Clinical trial NCT05280782
Conditions: Coronary Artery Disease
Keywords: myocardial perfusion imaging pharmacological stress biodistribution positron emission tomography myocardial blood flow
Sponsor: Washington University School of Medicine
Start date: 2022-01-05; Completion date: 2022-05-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is a single center, early phase 1 clinical imaging study designed to assess the dosimetry of 68Ga-Galmydar for PET/CT imaging.

Detailed description:
The objective is to evaluate dosimetry, biodistribution, safety, and imaging characteristics following a single 68Ga-Galmydar injection in normal healthy volunteers. Healthy adult normal volunteers (n=8, 4 males; 4 females) will undergo whole-body imaging (dosimetry group).

Healthy adult normal volunteers (n=8, 4 males; 4 females) will receive a single intravenous Ga-68 Galmydar administration of 8 mCi ± 20% (6.4-9.6 mCi) with a mass of ≤ 10 µg followed by whole-body PET/CT imaging.

Arms: arm 1: Normal Volunteers will receive a single intravenous injection of 8 mCi ± 20% (6.4-9.6 mCi) of the PET radiotracer 68Ga-Galmydar. They will undergo whole-body PET/CT imaging at three-time points, immediately post \[68Ga\]Galmydar injection, and at 2 hours and 4 hours after injection. Serum chemistries, complete blood count, EKG, vital signs, and physical examination will performed before injection and at the completion of the examinations.
Interventions: intervention 1: Ga-68 Galmydar
Intervention descriptions: intervention 1: Single intravenous injection of the PET radiotracer 68Ga-Galmydar.

Protocol documents:
Prot_SAP_000.pdf: 
Galmydar Protocol 
Version 4.1, 2022-12-06 
Confidential 
Page 1 of 49 
 
Protocol Title: Development and Translation of Generator-Produced PET Tracer for 
Myocardial Perfusion Imaging.  
Principal Investigator: 
Pamela K. Woodard, M.D.  
Professor of Radiology  
Washington University School of Medicine 
Mallinckrodt Institute of Radiology 
510 S. Kingshighway Blvd., Campus Box 8225 
St. Louis, Missouri, 63110 
Tel: 314-747-3386 
Fax: 314-362-6156 
E-mail: woodardp@wustl.edu  
IND Sponsor-Investigator: 
Vijay Sharma, Ph.D. 
Professor of Radiology 
Washington University School of Medicine  
Mallinckrodt Institute of Radiology 
510 S. Kingshighway Blvd., Campus Box 8225 
St. Louis, Missouri, 63110 
Tel: 314-362-9358 
Fax: 314-362-6156 
E-mail: sharmav@wustl.edu 
Exploratory Investigational New Drug (Sponsor-Investigator eIND) 
Investigational Drug: 
[68Ga]Galmydar 
FDA IND Number: 
157468 
IND Date of Activation: 
August 11, 2021 
IRB/HRPO: 
202107042 
RDRC: 
925  
Protocol Version Date, Number: 
December 06 2022, Version 4.1   
 
 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
Confidential 
Page 2 of 49 
REVISION HISTORY 
Date 
(yr-mo-day) 
Version 
Regulatory 
Committee 
Revision History 
2021-06-24 
1.0 
RDRC 
Original submission. Approvable letter received. 
2021-06-29 
2.0 
n/a 
RDRC revisions recommended to the Protocol, version 2.0 and 
Rest/Stress Consent, version 2.0: 
1. The interval between the rest and stress [68Ga]Galmydar PET 
acquisitions should be no less than 2 and no greater than 4 hours. 
2. Rest/Stress group: 13N-ammonia data acquisition revised to 10-min list-
mode (if the anterior-posterior diameter of the chest is >50cm increase 
to 15-min). 
2021-07-09 
2.0 
IRB 
Initial submission. 
2021-12-13 
2.1 
IRB 
Revised Protocol from version 2.0 to 2.1 
Bottom of pg. 20 
 
Whole-body PET image acquisition from head to mid-thigh. 
Imaging of subjects will be at three time points spanning from 
immediately after injection up to 4-hours after [68Ga]Galmydar 
injection. A low-dose spiral CT scan (120 kVp, 50 mAs) will be 
obtained for attenuation correction. Begin whole-body PET image 
acquisition from the head to mid-thigh immediately post 
[68Ga]Galmydar injection for 60-min and repeat at 2 hours and 4 
hours.  
2022-01-26 
3.0 
IRB 
Revising Protocol from version 2.1 to 3.0 
 
protocol on pages 18, 19, and 45. 
 
This is to add a second IV to the dosimetry group.  In this group we 
will use 1 IV to draw bloods, including the serum metabolites, and 
the second to inject the [68Ga]Galmydar. 
2022-07-26 
4.0 
IRB 
Revising protocol 3.0 to 4.0 
 
Protocol pages 16, 21, 36, 37, and 38.  
 
Reducing the dose of the radioactive tracer in the stress portion from 
8mCi to 6mCi on Day 1.  
Revising the reportable events table to page 36 as well.  
 
2022-12-6 
4.1 
IRB 
Increasing the reimbursement for rest/stress 
Changing galmydar imaging time from “up to 75 mins” to “90 mins” 
Changing rest/stress from 2 days to possibly 3 days 
Changing 2 IVs to possibly 1 IV 
  
 
 
 
 
 
 
 
 
 
 
 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
Confidential 
Page 3 of 49 
SUB-INVESTIGATORS 
Thomas H. Schindler, M.D.  
Authorized User 
Washington University School of Medicine  
510 S. Kingshighway Blvd. 
Campus Box 8225 
St. Louis, Missouri 63110 
Tel: 314-362-2809 
E-mail: thschindler@wustl.edu 
Robert J. Gropler, M.D. 
 
 
 
Washington University School of Medicine  
510 S. Kingshighway Blvd. 
Campus Box 8225 
St. Louis, Missouri, 63110 
Tel: 314-747-3878 
E-mail: rgropler@wustl.edu 
Richard Laforest, Ph.D. 
Washington University School of Medicine  
510 S. Kingshighway Blvd. 
Campus Box 8223 
St. Louis, Missouri, 63110 
Tel: 314-362-8423 
E-mail: rlaforest@wustl.edu 
Michael Nickels, Ph.D. 
Washington University School of Medicine  
510 S. Kingshighway Blvd. 
Campus Box 8225 
St. Louis, Missouri 63110 
Tel: 314-362-8246 
E-mail: mnickels@wustl.edu 
Richard Wahl, M.D. 
Washington University School of Medicine  
510 S. Kingshighway Blvd. 
Campus Box 8225 
St. Louis, Missouri, 63110 
Tel: 314-362-7100 
E-mail: rwahl@wustl.edu 
 
 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
Confidential 
Page 4 of 49 
TABLE OF CONTENTS 
REVISION HISTORY ..................................................................................................................2 
SUB-INVESTIGATORS ...............................................................................................................3 
TABLE OF CONTENTS ..............................................................................................................4 
1 
BACKGROUND ................................................................................................................7 
1.1SIGNIFICANCE .......................................................................................................................7 
1.2STUDY RATIONALE ...............................................................................................................9 
1.2.1 
Dosimetry Group ...................................................................................................... 9 
1.2.2 
Rest/stress Group ...................................................................................................... 9 
1.3RISKS AND BENEFITS ..........................................................................................................10 
2 
STUDY OBJECTIVES ....................................................................................................11 
2.1PRIMARY OBJECTIVE .........................................................................................................11 
2.2SECONDARY OBJECTIVES ..................................................................................................11 
3 
STATEMENT OF INVESTIGATOR ............................................................................11 
4 
STUDY DESIGN AND METHODS...............................................................................12 
4.1STUDY POPULATION ...........................................................................................................12 
4.2INCLUSION AND EXCLUSION CRITERIA .............................................................................12 
4.2.1 
Dosimetry Group .................................................................................................... 12 
4.2.2 
Rest/Stress Group.................................................................................................... 13 
4.3RECRUITMENT OF PARTICIPANTS ......................................................................................14 
4.4STUDY ENROLLMENT .........................................................................................................14 
4.4.1 
Dosimetry Group .................................................................................................... 15 
4.4.2 
Rest/Stress Group.................................................................................................... 15 
4.5EARLY DISCONTINUATION OF PARTICIPANTS ...................................................................15 
4.6PREMATURE WITHDRAWAL AND REPLACEMENT OF PARTICIPANTS ...............................15 
5 
INVESTIGATIONAL STUDY DRUG ..........................................................................16 
5.1DRUG DESCRIPTION ...........................................................................................................16 
5.2DRUG HANDLING, PREPARATION, AND RELEASE .............................................................16 
5.3DRUG ADMINISTRATION ....................................................................................................16 
5.3.1 
Dosage Variance ..................................................................................................... 16 
6 
STUDY PROCEDURES .................................................................................................17 
6.1SCREENING ASSESSMENTS .................................................................................................17 
6.2PET/CT IMAGING ..............................................................................................................18 
6.2.1 
PET Imaging Assessments and Preparation ........................................................... 18 
6.3DOSIMETRY GROUP - PET/CT IMAGING ..........................................................................20 
6.4REST/STRESS GROUP - PET/CT IMAGING ........................................................................21 
6.4.1 
Imaging Day-1, Rest/Stress [68Ga]Galmydar PET MPI ......................................... 21 
6.4.2 
Imaging Day-2, Rest/Stress 13N-Ammonia PET MPI ............................................ 22 
7 
SAFETY ASSESSMENTS ..............................................................................................23 
7.1CLINICAL LABORATORY TESTS .........................................................................................23 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 5 of 49 
7.2VITAL SIGN MEASUREMENTS ............................................................................................23 
7.312-LEAD ELECTROCARDIOGRAM .......................................................................................24 
7.4FOLLOW-UP ........................................................................................................................24 
7.4.1 
Dosimetry group ..................................................................................................... 25 
7.4.2 
Rest/Stress group .................................................................................................... 25 
8 
IMAGE PROCESSING AND ANALYSIS ....................................................................25 
8.1REST STRESS GROUP ..........................................................................................................25 
8.1.1 
PET Images ............................................................................................................. 25 
8.1.2 
MPI Interpretation ................................................................................................... 25 
8.1.3 
Coronary Angiography Interpretation..................................................................... 26 
8.1.4 
Kinetic Modeling for Imaging Quantification to Calculate Myocardial Uptake, MBF, 
and Retention ....................................................................................................................... 26 
9 
STATISTICAL PLAN .....................................................................................................27 
9.1SAMPLE SIZE JUSTIFICATION .............................................................................................27 
10 
REGULATORY AND SAFETY REPORTING ...........................................................28 
10.1 
REGULATORY COMPLIANCE.......................................................................................28 
10.2 
SAFETY EVENT DEFINITIONS ......................................................................................28 
10.2.1 Investigational Drug................................................................................................ 28 
10.2.2 Adverse Event ......................................................................................................... 28 
10.2.3 Suspected Adverse Reaction ................................................................................... 28 
10.2.4 Adverse Reaction .................................................................................................... 29 
10.2.5 Serious Adverse Event ............................................................................................ 29 
10.2.6 Life-threatening....................................................................................................... 29 
10.2.7 Unexpected ............................................................................................................. 30 
10.3 
CAUSALITY AND SEVERITY ASSESSMENT...................................................................30 
10.3.1 Severity/Intensity .................................................................................................... 30 
10.3.2 Attribution ............................................................................................................... 31 
10.4 
DOCUMENTING ADVERSE EVENTS .............................................................................31 
10.5 
FOOD AND DRUG ADMINISTRATION MANDATORY REPORTING ...............................31 
10.5.1 “7-day” Reportable Events ..................................................................................... 32 
10.5.2 “15-day” Reportable Events ................................................................................... 32 
10.5.3 Follow-up Reporting ............................................................................................... 32 
10.5.4 Annual Report ......................................................................................................... 32 
10.5.5 Reporting Events to the FDA .................................................................................. 32 
10.6 
INSTITUTIONAL REVIEW BOARD MANDATORY REPORTING .....................................33 
10.6.1 IRB/HRPO Definitions ........................................................................................... 33 
10.6.2 Reporting Events to IRB/HRPO ............................................................................. 34 
10.7 
REPORTING TO RADIOACTIVE RESEARCH DRUG COMMITTEE ................................35 
10.8 
TIMEFRAME FOR REPORTING REQUIRED EVENTS ....................................................35 
TABLE 1 - REPORTABLE EVENTS ......................................... ERROR! BOOKMARK NOT DEFINED. 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 6 of 49 
11 
EXPECTED RISKS .........................................................................................................37 
11.1 
[68GA]GALMYDAR RISKS ............................................................................................37 
11.2 
13N-AMMONIA RISKS ..................................................................................................37 
11.3 
RADIATION EXPOSURE................................................................................................37 
11.3.1 Low-dose CT .......................................................................................................... 37 
11.3.2 [68Ga]Galmydar and 13N-Ammonia PET ................................................................ 38 
11.4 
REGADENOSON ............................................................................................................39 
11.5 
PET/CT IMAGING SCANNER ......................................................................................39 
11.6 
INTRAVENOUS CATHETER PLACEMENT .....................................................................39 
11.7 
QUESTIONNAIRES ........................................................................................................39 
11.8 
BREACH OF CONFIDENTIALITY ..................................................................................39 
11.9 
OTHER RISKS ...............................................................................................................40 
12 
DATA SAFETY MONITORING PLAN .......................................................................40 
13 
DATA COLLECTION, RETENTION, AND DATA MANAGEMENT ....................40 
13.1 
DATA COLLECTION FORMS ........................................................................................40 
13.2 
RECORDS MANAGEMENT ............................................................................................41 
13.3 
RETENTION AND AVAILABILITY OF RECORDS ...........................................................41 
13.3.1 Archival of Imaging Data ....................................................................................... 41 
14 
PROTECTIONS, RIGHTS, AND CONFIDENTIALITY ...........................................42 
14.1 
INFORMED CONSENT ...................................................................................................42 
14.2 
CONFIDENTIALITY ......................................................................................................42 
14.2.1 Certificate of Confidentiality .................................................................................. 43 
14.3 
DATA PROTECTION .....................................................................................................43 
14.4 
DATA SECURITY ..........................................................................................................43 
14.5 
FUTURE USE OF DATA/ DATA SHARING .....................................................................43 
15 
ETHICAL AND FINANCIAL CONSIDERATIONS ..................................................44 
15.1 
WASHINGTON UNIVERSITY INSTITUTIONAL REVIEW BOARD...................................44 
15.2 
FUNDING SOURCE .......................................................................................................44 
15.3 
CONFLICT OF INTEREST ..............................................................................................44 
15.4 
PARTICIPANT COMPENSATION ...................................................................................45 
16 
ATTACHMENTS ............................................................................................................45 
TABLE 2. SCHEDULE OF ACTIVITIES–DOSIMETRY GROUP ...................................................46 
TABLE 3. SCHEDULE OF ACTIVITIES–REST/STRESS GROUP .................................................47 
17 
REFERENCES .................................................................................................................49 
 
 
 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 7 of 49 
1 
BACKGROUND 
While exploring structure-activity relationships of organic ligands possessing an N4O2 donor core  
[1-3], we identified a gallium-68-radiopharmaceutical (named herein as 68Ga-Galmydar) that 
demonstrates high extraction into the myocardium of mice, rats, and rabbits while also displaying 
efficient clearance from the blood pool. Additionally, [68Ga]Galmydar is recognized by MDR1 P-
glycoprotein (Pgp) [4] and Breast Cancer Resistance Protein (BCRP, ABCG2) [5] as their efficient 
transport substrate, and thus it exploits transporter-mediated excretion pathways from the blood 
and liver, resulting in high heart/blood and heart/liver ratios 60-minute post injection. Live cell-
imaging of rat cardiomyoblasts using Galmydar (fluorescent probe) shows  its localization within 
the mitochondria following permeation within cells indicating excellent correlation with 
radiotracer uptake data [4,5]. [68Ga]Galmydar micro positron emission tomography 
(PET)/computed tomography (CT) imaging of rat and rabbit hearts show high myocardial uptake 
and high target/background contrast. Following ligation of the left anterior descending (LAD) 
coronary artery in rat and rabbits, PET/CT imaging clearly showed the hypoperfused region of the 
left ventricle wall. These hypoperfused regions of the myocardium correlated well to the same ex 
vivo regions by histochemical staining post imaging. [68Ga]Galmydar has also shown sensitivity 
in monitoring ischemia caused by transient ligation of LAD in rabbits on PET imaging, also with 
positive correlation of the ischemic region with ex vivo histology. Radiation dosimetry studies in 
mice extrapolated to human dosimetry estimates using Medical Internal Radiation Dosimetry 
(MIRD) methodology and employing FDA guidelines (21 CFR 312) of maximum allowable dose 
to any organ of 50 mSV indicate an allowable maximum injection dose of 8 mCi in humans. This 
is comparable to 18F-Flurpiridaz, another myocardial perfusion imaging (MPI) agent undergoing 
Phase 3 studies. Importantly, 6[68Ga]Galmydar does not demonstrate any remarkable clinical 
pathology (toxicology) in critical organs following intravenous administration of a single dose 
(1000 fold excess of an IV imaging dose) of an unlabeled agent into rats over 14 days. Finally, 
compared to 13N-ammonia (a positive control), [68Ga]Galmydar also demonstrates similar 
radiotracer characteristics and, in particular, comparable  myocardial first pass extraction of about 
70-90% so that regadenosone-induced stress myocardial perfusion and myocardial blood flow 
(MBF) quantification employing kinetic modeling should be comparable [6,7,8 ]  
Thus, this study is designed to demonstrate feasibility of [68Ga]Galmydar for the noninvasive 
detection and characterization of subclinical and clinically-manifest coronary artery disease 
(CAD) in conjunction with PET by its comparative analysis to 13N-ammonia PET rest and stress 
studies in human subjects (n=20, 10 males and 10 females). Secondary aims are to evaluate 
dosimetry, biodistribution, and safety, and imaging characteristics following a single injection in 
normal healthy volunteers at rest (n=8, 4 males; 4 females). 
1.1 
Significance  
Existing state-of-the art MPI tracers have certain limitations, such as low sensitivity, poor spatial 
resolution, attenuation artifacts, slow liver clearance, and nonlinearity of MBF at high flow rates. 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 8 of 49 
To overcome these shortcomings, new MPI agents are desired. Utility of PET MPI agents, such as 
13N-ammonia, and H215O is limited due to the requirement for proximity to a multimillion dollar 
cyclotron. In addition, myocardial perfusion examinations using 82RbCl3 suffer from low first pass 
extraction, low spatial resolution because of the higher positron range, and short radionuclide half-
life due to both potential oversaturation of the detectors at the beginning of the acquisition due to 
injected high dose, and low count statics and suboptimal signal/noise ratios at later time points. 
Conversely, Gallium-68 based agents offer tremendous advantages as potential PET MPI agents 
and are likely to widely resolve these shortcomings.  
Using Gallium-68, Galmydar incorporates four important components into its pharmacophore 
design: a) a rationale built upon exploiting transporter-mediated efflux pathways (Pgp and BCRP 
substrates) to facilitate excretion from neighboring tissues, such as liver and blood, to allow high 
heart-to-liver and heart-to-blood ratios enabling  high target/ background ratios, b) moderately 
hydrophobic cationic probes possessing a delocalized positive charge on their molecular surface 
to allow penetration of myocardium in response to favorable negative plasma- and mitochondrial 
transmembrane potentials, thereby producing high first-pass extraction and minimal washout from 
myocardium during imaging sessions, c) a PET agent that incorporates a generator-produced 
radionuclide, 68Ga (t1/2 = 68 min), to allow production of the radiopharmaceutical independent of 
the availability of a nearby cyclotron, and d) a potential technology conducive for business models 
of kit distributions comprising a ligand with a long shelf-life, thereby enabling onsite production 
for imaging in clinics. These combined elements indicate that further development of 
[68Ga]Galmydar and its translation is based upon the strong scientific premise.  
Also, using both rats and rabbits, micro-PET and nano-single photon emission computed 
tomography (SPECT) imaging directly showed high heart uptake of [67Ga]Galmydar and rapid 
clearance from the liver within 30 min post injection, indicating its ability to serve as a potential 
myocardial perfusion agent for both PET and SPECT. In this regard, the faster kinetics and short 
half-life of [68Ga]Galmydar may lead to improved dosimetry over 18F-Flurpiridaz, another 
mitochondrial complex I targeted MPI agent. Moreover, Complex I deficiency, which is clinically 
and genetically heterogeneous, can present with hypertrophic cardiomyopathy that could either be 
isolated or associated with other comorbidities.  . Therefore, the lower uptake of a given 
mitochondrial Complex I targeted agent, such as 18F-Flurpiridaz could also potentially be 
influenced by these complications. Compared with the performance of 18F-Flurpiridaz in these 
areas, the design of [68Ga]Galmydar is based upon an established and successful biochemical 
model for development of MPI agents.  Importantly, the robust biochemical validation of 
Galmydar in  cellulo  (radiotracer,  and  optical imaging assays) and in mice, rat, and rabbit models 
of both permanent and transient LAD ischemia, with response to pharmacological stress, 
toxicology studies in rats, and  dosimetry  studies  in  vivo,  provide  us  with  a  sound  platform  
for  further versatile molecular imaging probes for quantifying myocardial perfusion and MBF in 
humans.  


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 9 of 49 
1.2 
Study Rationale 
1.2.1 Dosimetry Group 
The successful implementation of [68Ga]Galmydar in humans could provide a new mechanism-
driven tracer for PET MPI, and successful realization of aims could ultimately take PET MPI to 
underserved regions nationwide and developing countries worldwide, where an 18F-distribution 
business model would have limitations. [68Ga]Galmydar PET MPI could enable quantification of 
myocardial flow reserve (MFR= stress MBF / rest MBF that carries important diagnostic and 
prognostic information) that may play an additional important role to evaluate or monitor the 
effectiveness of preventive medical care or the treatment response on the function of the heart 
vessels in CAD individuals. These benefits combined with the minimal risks weight the ratio in 
favor of moving the PET radiotracer [68Ga]Galmydar into human subjects. This component of the 
study will determine the biodistribution and calculate the radiation dosimetry of [68Ga]Galmydar 
in normal healthy volunteers. Our radiation dosimetry studies in mice [9] extrapolated to human 
dosimetry estimates using MIRD methodology suggest an allowable maximum injection dose of 
8 mCi in humans. The maximum Effective Dose for one 8 mCi intravenous administration of 
[68Ga]Galmydar and three whole-body CT scans with CT attenuation scans results in a gender 
average radiation dose of 2.84 rem that is well within 57% of the allowable annual dose for 
radiation workers.  
1.2.2 Rest/stress Group 
A rest/stress myocardial 13N-ammonia PET/CT is clinically indicated for the detection of flow-
limiting, obstructive coronary artery disease (CAD). Myocardial perfusion PET provides images 
of a higher quality than SPECT, due to higher spatial and contrast resolution, higher scanner 
sensitivity, and accurate attenuation correction. In addition, the concurrent quantification of 
myocardial blood flow (MBF) affords the assessment of hyperemic MBF during pharmacologic 
vasodilation and at rest and, thus, the computation of the myocardial flow reserve (MFR= MBF 
stress/MBF rest). The concurrent assessment of hyperemic MBF and/or MFR aids in the 
identification and characterization of multi-vessel CAD, microvascular dysfunction, and 
prognostication.   
We will compare the results of [68Ga]Galmydar PET/CT MPI to the results of 13N-ammonia 
PET/CT MPI in a group of 20 symptomatic patients and 10 normal control subjects without 
symptomatology. Half of the symptomatic patients recruited will have  a SPECT MPI study 
positive for ischemia in two myocardial segments with referral for invasive coronary angiography 
(ICA) as part of their routine standard-of-care (n=10), and half with normal SPECT MPI and no 
ICA referral (n=10).  Patients referred for ICA will undergo their [68Ga]Galmydar and 13N-
ammonia PET/CT MPI studies prior to intervention. In addition, as a completely normal control, 
another 10 subjects without symptomatology or known cardiovascular disease will also undergo 
both 13N-ammonia PET/CT MPI and [68Ga]Galmydar PET/CT MPI.  In total 30 patients or normal 
human subjects will be studied. 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 10 of 49 
1.3 
Risks and Benefits  
[68Ga]Galmydar shows critical traits desirable in PET MPI. Additionally, despite the fact that 
concentrations of radiotracer needed for PET imaging are extremely low and rarely a concern, 
preclinical toxicity studies were conducted and thoroughly investigated according to FDA 
guidelines for new radiopharmaceuticals. The small animal toxicity report is located in the 
appendices of the initial IND submission.  
In summary, a non-GLP 14-day single dose exploratory toxicity study of Galmydar was performed 
in male and female Sprague Dawley rats (study number, 2682-207370NI, Innotiv Maryland 
Heights, Missouri). The toxicity of Galmydar, a radiopharmaceutical diagnostic drug, was studied 
when administered as a single intravenous (IV) dose to male and female Sprague Dawley rats.  Ten 
animals per sex from each group were euthanized for postmortem examination 24 hours after dose 
administration and 5 animals per sex from each group were euthanized for postmortem 
examination on Day 14 after administration. 
Each treatment group (Group 1 and Group 2) was comprised of 15 male and 15 female Sprague 
Dawley rats.  On Day 1, rats were administered either the vehicle control (Group 1) or 0.8 mg/kg 
Galmydar (Group 2) via IV injection at a dose volume of 1 mL/kg. 
Physical examinations were conducted prior to randomization into groups. Clinical observations 
were recorded hourly at 1, 2, and 3 hours post-dose and once daily on Days 2–14.  Body weights 
were measured prior to initiation of dosing on Day 1 and daily thereafter.  Mortality observations 
were recorded once daily (PM observations).  Blood samples for the evaluation of clinical 
chemistry and hematology endpoints were collected on Day 2 and Day 14 from both groups. 
Following blood sample collections, necropsy was conducted.  Protocol-specified tissues were 
collected and evaluated grossly, select organs were weighed, and tissues were fixed for 
microscopic evaluation.  A subset of fixed tissues were subsequently processed and evaluated 
microscopically.  
Based on the absence of test article-related effects on body weight, clinical observations, clinical 
pathology or microscopic findings, a single IV administration of 0.8 mg/kg of Galmydar was well-
tolerated in male and female Sprague Dawley Rats at both 24 hours (Day 2) and 14 days after 
dosing.  
The findings above decrease the likelihood that human toxicity will be a hurdle. While information 
in humans is not yet available, our preliminary animal data shows high agreement in MPI 
performed with [68Ga]Galmydar and 13N-ammonia. The success of this study of [68Ga]Galmydar 
in human subjects could provide a mechanism-driven tracer for PET MPI, and ultimately take PET 
MPI to underserved regions nationwide and developing countries worldwide, wherein 18Fluorine 
distribution business models have limitations, with requirements for nearby cyclotron facilities. 
Overall, [68Ga]Galmydar PET MPI could enable quantification of myocardial flow reserve that 
carries important diagnostic and prognostic information and that may play an important role in the 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 11 of 49 
diagnosis of coronary artery disease and in the evaluation and monitoring of the effectiveness of 
treatment response. These benefits and minimal risks weight the ratio in favor of this hypothesis-
driven diagnostic imaging research project. 
2 
STUDY OBJECTIVES 
2.1 
Primary Objective 
The primary objective of the proposed study is to evaluate the potential of [68Ga]Galmydar 
PET/CT MPI for the noninvasive detection of coronary artery disease. We will evaluate 
[68Ga]Galmydar PET/CT MPI in comparison to 13N-ammonia PET/CT MPI to quantitatively 
assess myocardial blood flow (MBF) in patients with suspected or known coronary artery disease 
(CAD) undergoing clinical SPECT MPI. In addition, perfusion and MBF findings with 
[68Ga]Galmydar will be compared to the results of coronary morphology or stenosis severity in 
those patients undergoing invasive coronary angiography (ICA) based on abnormal SPECT MPI. 
The performance of rest/stress [68Ga]Galmydar PET/CT in comparison to 13N-ammonia PET/CT 
in normal subjects without cardiovascular disease will be performed as a control. 
2.2 
Secondary Objectives 
To evaluate dosimetry, biodistribution, and safety, and imaging characteristics following a single 
[68Ga]Galmydar injection in normal healthy volunteers at rest. 
3 
STATEMENT OF INVESTIGATOR  
Vijay Sharma, Ph.D, the Sponsor-Investigator of the IND, Pamela K. Woodard, M.D., Principal 
Investigator, and Thomas Schindler, M.D., Authorized User will comply with the state and federal 
regulations related to the conduct of all clinical investigations with the administration of 
[68Ga]Galmydar. A Form FDA 1572 is included with the IND application. 
The study protocol will not be initiated before receiving all required regulatory approvals obtained 
from the Institutional Review Board (IRB)/Human Research Protection Office (HRPO), the 
Radioactive Drug Research Committee (RDRC), and receipt of the study activation letter from the 
Food and Drug Administration (FDA). 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 12 of 49 
4 
STUDY DESIGN AND METHODS 
A single center, phase 0/1 clinical imaging study designed to assess the role of [68Ga]Galmydar 
PET/CT imaging in human subjects.  
4.1 
Study Population  
We will recruit up to 38 participants for the dosimetry and rest/stress groups. Healthy adult normal 
volunteers (n=8, 4 males; 4 females) for whole-body imaging (dosimetry group) and patients who 
had a prior clinical SPECT MPI examination that is positive or negative for ischemia.  
Thirty (30) subjects will be enrolled in the rest/stress group. Symptomatic patients (n=20) will 
have undergone a SPECT MPI examination. Ten patients in this group will have had a study 
positive for ischemia in two myocardial segments and referred for invasive coronary angiography 
(ICA) as part of their routine standard-of-care. [68Ga]Galmydar PET imaging will occur prior to 
intervention. The other ten patients will have a normal SPECT MPI and no ICA referral. Subjects 
(n=10) who are asymptomatic and without history of cardiovascular disease will serve as a normal 
controls. 
4.2 
Inclusion and Exclusion Criteria  
In order for participants to be eligible for study enrollment, an individual must meet the inclusion 
criteria. An individual who meets any of the exclusion criteria will be excluded from participation 
in the study. 
4.2.1 Dosimetry Group 
Healthy adult normal volunteers will be enrolled in the dosimetry group.   
4.2.1.1 Inclusion criteria 
• Healthy men and women, 18–99 years of age and any race;  
4.2.1.2 Exclusion criteria 
• Inability to receive and sign informed consent;  
• Positive urine screen for drugs of abuse at screening or before dosing or over-the-counter 
drug use or herbal preparations within the 2-week period prior to enrollment;  
• Participation in another research study with a study drug, including a diagnostic or 
therapeutic radiopharmaceutical, to be administered during this study or which was or 
will be administered within 10 half-lives of the radiopharmaceutical. 
• Severe claustrophobia; 
• Pregnant or breastfeeding. 
• Body mass index < 18 kg/m2 or > 40 kg/m2. 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 13 of 49 
4.2.2 Rest/Stress Group 
Twenty symptomatic patients will have undergone a SPECT MPI examination. Ten of these 
patients will have had a study positive for ischemia in two myocardial segments and referred for 
invasive coronary angiography (ICA) as part of their routine standard-of-care. [68Ga]Galmydar 
PET imaging will occur prior to intervention. The other ten patients will have had a negative for 
ischemia SPECT MPI and no ICA referral. Ten healthy adult normal volunteers, who are 
asymptomatic, without history of cardiovascular disease or significant cardiovascular risk factors, 
will serve as control subjects. 
Asymptomatic normal controls and symptomatic patients who have undergone a SPECT MPI 
examination that is normal or positive and prior to ICA intervention, will undergo a rest/stress 
[68Ga]Galmydar PET MPI and rest/stress 13N-ammonia PET MPI with a minimum of a 3-day 
separation.  
4.2.2.1 Inclusion Criteria  
• Male and female, 18-99 years of age and any race;  
• Have had a prior clinical SPECT MPI positive for ischemia in two myocardial segments 
and referred for invasive coronary angiography (ICA) or have had a prior clinical SPECT 
MPI negative for ischemia; 
4.2.2.2 Exclusion Criteria 
• Inability to receive and sign informed consent;  
• Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) 
within 6-months prior to SPECT or in the intervening days between SPECT and PET 
examination; 
• Participants who have received chemotherapeutic agents within 6 months of enrollment; 
• Heart failure (left ventricular ejection fraction ≤ 35%); 
• Known non-ischemic cardiomyopathy;  
• Inability to undergo pharmacologic stress testing with regadenoson (Lexiscan). 
Contraindications include:  
o Symptomatic bradycardia or second to third degree atrioventricular (AV) block;  
o Pre-existing obstructive lung disease with active wheezing, i.e., COPD, asthma 
with active wheezing that precludes the safe administration of the pharmacological 
stress agent according to the approved label; 
o Uncontrolled and severe hypertension (e.g. systolic blood pressure >200 mmHg, 
diastolic blood pressure >110 mmHg); 
o Baseline hypotension (e.g. systolic blood pressure < 90 mmHg, diastolic blood 
pressure <50 mmHg); 
• Women who are pregnant or  breastfeeding; 
• Severe claustrophobia; 
• Weight ≥ 500 lbs (weight limit of PET/CT table) 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 14 of 49 
• Administration of any diagnostic or therapeutic radiopharmaceutical, not part of this 
study, within a period either prior to or after equal to 10 half-lives of the 
radiopharmaceutical. 
• Any condition that in the opinion of the Principal Investigator or designee could increase 
risk to the participant, limit the participant’s ability to tolerate the research procedures or 
interfere with collection of the data such as: 
o Inability to lie still or unable to tolerate a supine position with arms up over the 
head for up to a 60-minute PET scan due to chronic back/shoulder pain or arthritis 
as assessed by physical examination and/or medical history; 
o Current or past history of major medical illness, i.e., severe kidney or liver 
problems; 
o Patients who suffer an intervening clinical event such as worsening angina pectoris 
or myocardial infarction or whom undergo a myocardial revascularization 
procedure or have myocardial ischemia at rest; 
4.3 
Recruitment of Participants 
We will recruit healthy adult normal volunteers for the Dosimetry group and Rest/Stress group 
from the community through the Research Participant Registry/Volunteer for Health (VFH) 
Program at Washington University in St. Louis (https://vfh.wustl.edu). 
Study patients enrolled in the rest/stress group will be for the assessment of the efficacy of 68Ga-
Galmydar. Patients referred for routine SPECT MPI in the Division of Nuclear Medicine or from 
the cardiology inpatient/outpatient clinics at Barnes-Jewish Hospital/Washington University in St. 
Louis will be recruited.  
Participants’ electronic health records (EHR) will be accessed to review general health information 
for contraindications to planned study procedures and confirm pre-eligibility. A study team 
member will call potential subjects to discuss the study and answer any questions. Participants 
who verbally agree to participate will be scheduled for study visits. 
4.4 
Study Enrollment 
Upon arrival to the imaging facility, participants will be provided the informed consent for review. 
The study coordinator will review the informed consent form with the participant and address any 
questions or concerns prior to obtaining written consent or performing any research procedures.  
Participants must be willing and able to undergo all procedures. 
Imaging will begin with the healthy adult normal volunteers enrolled in the dosimetry group. The 
first two, (2) normal volunteers will be separated by 2-3 days to ensure participant safety data is 
ascertained during the post-injection phone follow-up. Upon completion of the review, the study 
will continue with imaging of the remaining dosimetry subjects with simultaneous entry of the 
rest/stress group. 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 15 of 49 
4.4.1 Dosimetry Group  
Eight healthy adult normal volunteers (4 males and 4 females) will be enrolled in the dosimetry 
group and undergo whole-body PET/CT imaging with 68Ga-Galmydar.  
4.4.2 Rest/Stress Group 
For the rest/stress group, we will recruit 30 subjects. The first set will be symptomatic patients 
(n=20) who have undergone a SPECT MPI examination. Half of these patients will have had a 
study positive for ischemia in two myocardial segments and referred for invasive coronary 
angiography (ICA) as part of their routine standard-of-care (n=10). Subjects will undergo 
[68Ga]Galmydar PET/CT prior to any intervention. The second half of these patients will have had 
a normal SPECT MPI and no ICA referral (n=10). A second set of subjects who are normal, 
asymptomatic, and without a history of cardiovascular disease will serve as controls (n=10). 
4.5 
Early Discontinuation of Participants  
The Principal Investigator or designee may prematurely discontinue a participant at any time if the 
constraints of the protocol are considered to be not in the best interest of the participant, i.e., 
increased risks jeopardizes the safety of the participant. Reasons maybe related to an adverse event 
that in the opinion of the Principal Investigator or designee requires the participant should be 
withdrawn. Other reasons may include non-compliance with study procedures, lost to follow-up, 
or a positive pregnancy test. 
Participants who develop hypertension, hypotension, or other adverse event secondary to the  
regadenoson administration during the PET/CT MPI stress component and if in the Principal 
Investigator or designee’s opinion the enrolled participant is deemed ineligible to safely undergo 
the stress 13N-ammonia PET study, the participant may be allowed to continue participation. The 
stress portion of the 13N-ammonia PET study will be removed. The participant will only undergo 
the rest portion of the 13N-ammonia PET study. 
4.6 
Premature Withdrawal and Replacement of Participants 
Any participant who no longer wishes to continue participation may withdraw consent at any time 
and for any reason without prejudice. Withdrawal will not interfere with routine clinical care. 
Participants are informed to contact a study team member, e.g., study coordinator or by sending a 
withdrawal letter to the Principal Investigator or designee as listed in the Informed Consent Form. 
Attempts will be made to discuss with the participant the reasons for withdrawal and the 
importance of the study evaluations.  
Include documentation of reason(s) for discontinuation or withdrawal in the enrollment log. 
Withdrawn participants are not allowed to re-enroll into the study. Participants who do not 
complete all protocol-required procedures are replaced to ensure adequate evaluable data. 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 16 of 49 
5 
INVESTIGATIONAL STUDY DRUG 
5.1 
Drug Description 
The investigational study drug is 68Ga-Galmydar. Gallium-68 is a positron-emitting radioisotope 
that is produced from a 68Ge/68Ga generator with a physical half-life of 67.7 minutes. An 
Investigator’s Brochure does not exist for this radioactive drug. The pharmacological properties 
and formulation are described in detail in the Chemistry, Manufacturing, and Control Data section 
of the IND application. 
5.2 
Drug Handling, Preparation, and Release 
Handling of all radioisotopes will be conducted under the auspices of the Radiation Safety Office 
at Washington University School of Medicine (WUSM). [68Ga]Galmydar will be produced under 
the leadership of the Director of the WUSM Cyclotron Facility, and under the supervision of the 
Associate Director of the Cyclotron Production and the Director of the Radiopharmacy. Trained 
personnel perform the preparation and quality control tests for the release of [68Ga]Galmydar under 
the supervision of the radiopharmacist in charge. 
5.3 
Drug Administration 
The Sponsor-Investigator will adhere to the procedures and requirements in accordance with 
applicable policies of the Radiation Safety Committee (RSC) at Washington University and the 
U.S. Nuclear Regulatory Commission (NRC). 
A PET-certified medical professional will draw, administer, and assay the dosage in a dose 
calibrator before and after the administration of all radiotracers.   
The Dosimetry group will receive one single intravenous administration of 8 mCi ± 20% (6.4‒9.6 
mCi) of 68Ga-Galmydar. The Rest/Stress Group will receive two intravenous administrations of 
68Ga-Galmydar, 4 mCi ± 20% (3.2‒4.8 mCi) during rest and 6 mCi ± 20% (4.8-7.2 mCi) during 
the stress of  [68Ga]Galmydar on the PET MPI Imaging Day-1. The acceptable mass for each 
[68Ga]Galmydar administration is ≤ 10 µg. On Imaging Day-2, subjects will receive two single 
intravenous administrations each of 10 mCi ± 20% (8‒12 mCi) of N-13 Ammonia.  
5.3.1 Dosage Variance  
If a required administered dosage is outside the allowable range because of unforeseen 
circumstances, i.e., lack of radiopharmaceutical activity, an authorized user physician before 
administration of the tracer must approve a dosage in writing or verbally as a variance. The 
authorized user must provide written approval to the imaging facility within 48-hours after a verbal 
approval. All members of the research team will comply with the Washington University Radiation 
Safety Committee Policy on Dispensing of Radiopharmaceutical Dosages for Human Research 
Subjects. 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 17 of 49 
6 
STUDY PROCEDURES 
The Schedule of Activities (SoA) tables for the Dosimetry group and Rest/Stress group 
summarizes the study assessments and procedures, see Attachments. The results of all assessments 
and evaluations will be recorded on the case report forms. The PI or sub-investigator delegated by 
the PI will review screening and evaluations to confirm eligibility criteria of all enrolled subjects. 
The research study team will be maintain study logs, e.g., screening and enrollment logs of 
participants with details of screen failures, dropouts and adverse event log.   
6.1 
Screening Assessments 
The coordinator will review the informed consent form and address questions or concerns with the 
participant and family/friends. Relevant medical history includes current and past 
diseases/illnesses and concurrent medications, as well as surgical and family medical history. A 
brief physical exam will be conducted by the Principal Investigator or designee. A designee is one 
who is a qualified, engaged member and protocol trained to assess participants. Exams are 
performed at baseline prior to the [68Ga]Galmydar injection to determine if the participant is 
suitable to undergo study procedures and for subject readiness prior to discharge from the imaging 
center. 
Screening will include the following procedures and evaluations to ensure participants meet 
inclusion and exclusion criteria. 
• Written informed consent will be obtained prior to performing any research procedures; 
• Demographics, including gender, date of birth, race, and ethnicity; 
• Medical history, including family history and surgical history (e.g., pre-existing conditions 
and shoulder or chest trauma) as obtained from participants and available medical records, 
as described below; 
• PET/CT contraindications; 
• Concomitant medications review, including non-prescription medicines, vitamins, herbs, 
and supplements; 
• Body weight and height measurements; 
• A brief physical exam; 
• Vital sign measurements, including systolic and diastolic blood pressure, heart rate, and 
respiratory rate, body temperature; 
• 12-lead ECG; 
• For women of childbearing potential, a urine pregnancy test must be completed, 
documented, and confirmed as negative within 24-hrs or on the day of the PET scan. 
Confirm participant is not breastfeeding and agrees not to become pregnant (refrain from 
sexual activity or is currently using a medically approved method of contraception) to 
continue for at least 24-hours post-injection of 68Ga-Galmydar;  


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 18 of 49 
• Clinical Laboratory Testing: clinical safety labs includes a complete blood count, 
comprehensive metabolic panel, and urinalysis. All participants will have up to two IV 
catheters inserted one in each arm. In dosimetry patients, one IV will be used for the 
collection of blood samples for the lab tests to include serum metabolites, and the second 
will be used for the administration of 68Ga-Galmydar. For patients enrolled in the rest/stress 
group, one IV catheter will be used for the [68Ga]Galmydar administration and the second 
IV will be used for the administration of the pharmacological stress agent, regadenoson.  
 
6.2 
PET/CT Imaging 
Imaging will be conducted on the preferred scanner, the Siemens Biograph Vision PET/CT. The 
Biograph TruePoint/TrueView may be used alternatively in the event of a schedule conflict or 
scanner problem. The scanners are located adjacent to each other in the Center for Clinical Imaging 
Research (CCIR) at the Washington University School of Medicine (WUSM) and Barnes-Jewish 
Hospital (BJH) in St. Louis.  
The CCIR allows participants to undergo research-related imaging protocols in a safe environment. 
The CCIR is fully equipped for the treatment of medical emergencies, including cardiac arrest 
(crash-cart, intubation equipment, and defibrillator), and is served by BJH emergency code team. 
The CCIR Facility operates in compliance with the Joint Commission on Accreditation of 
Healthcare Organization (JCAHO), and the American College of Radiology (ACR). All facilities 
operate in compliance with the safety guidelines for imaging and for privacy as directed by the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Nuclear Regulatory 
Commission (NRC).  
PET radiopharmaceuticals will be produced at Washington University School of Medicine 
(WUMS)-Mallinckrodt Institute of Radiology (MIR) Cyclotron Facility.  For investigational PET 
drugs for human use produced under an Investigational New Drug (IND) application in 
accordance with 21 CFR Part 312. WUMS MIR Cyclotron Facility follows the requirement for 
production of research radiopharmaceuticals in 21 CFR Part 212, Current Good Manufacturing 
Practice (CGMP) For Positron Emission Tomography Drugs, by complying with the 
regulations in Chapter <823>, Radiopharmaceuticals for Positron Emission Tomography 
(PET)—Compounding, Investigational, and Research Uses.  
6.2.1 PET Imaging Assessments and Preparation 
Subjects will be instructed to fast overnight for a minimum of 6-hours prior to the scheduled 
appointment time. The Rest/Stress group subjects who undergo the stress PET MPI will be 
instructed to avoid theophylline-containing medication or dipyridamole for at least 48 hours prior 
to the stress imaging scan. Vasoactive medications such as calcium-channel blockers, angiotensin-
converting enzyme inhibitors, β-blockers, and nitrates should be discontinued at least 24 hours before 
the PET perfusion examination. 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 19 of 49 
The following assessments and procedures will be performed for PET imaging visits: 
• Confirm eligibility. Review concomitant medications and any changes in health since the 
screening if assessments were performed on a separate day. Repeat between imaging days; 
• Confirm or perform and document a negative urine pregnancy test for women of 
childbearing potential for each imaging day; 
• Subjects will be requested to use the restroom to empty their bladder prior to radiotracer 
injection and discharge from the imaging facility;  
• Place one peripheral intravenous (IV) catheter for the administration of radiotracer 
injection and draw blood samples for safety labs. Both the dosimetry group and the 
rest/stress group will have a second contralateral IV catheter placed. In the dosimetry 
group, one IV will be used for collection of safety labs and radiotracer metabolites and one 
IV will be used for the administration of [68Ga]Galmydar.  In the rest/stress patients, one 
IV will be used for the administration of [68Ga]Galmydar  and one for the administration 
of the pharmacological stress agent, regadenoson; 
• Collect blood and urine samples for clinical safety lab tests for [68Ga]Galmydar participants 
at screening to be used for a baseline pre-injection measurement and repeated after the 
imaging prior to discharge post [68Ga]Galmydar injection and; 
• Perform a brief physical exam for [68Ga]Galmydar participants. The screening exam may 
be used for baseline pre-injection measurement and repeated post [68Ga]Galmydar 
administration; 
• Place the participant on the imaging table in supine position with both arms 
positioned above the head.  To ensure participant comfort, place a pillow or folded towels 
under elbows and pillows or foam wedge under legs of the participant to maintain their 
position for the duration of the scan; 
• Place electrodes on the participant’s chest for continuous ECG monitoring and capturing 
of 12-lead ECG. Place a blood pressure cuff on the opposite arm used for the 
administration of the radiotracer. Continue to monitor ECG-rhythm and HR until imaging 
is completed; 
• Obtain vital sign (VS) measurements and 12-lead ECG at the time points listed below and 
repeat as needed for [68Ga]Galmydar participants. VS include heart rate, respiratory rate, 
and diastolic and systolic blood pressure, body temperature. Obtain vital signs (BP and 
HR) and 12-lead ECG as required per clinical protocol for the rest/stress Ammonia PET 
MPI study.  
o Baseline:  VS (BP, HR, RR, and body temperature) and a 12-lead ECG within 60-
min prior to injection, repeat if >60-min; 
o Pre-injection: BP, HR, and RR within 15-min; 
o Post-injection: BP, HR, and RR within 5-min and 15-min, and hourly during 
imaging visit; 
o End of imaging scan:  BP, HR, and RR; 
o Prior to Discharge:  VS (BP, HR, RR, and body temperature) and a 12-lead ECG. 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 20 of 49 
• Instruct participants to not move arms, head, or bend knees throughout the study to reduce 
motion artifacts;  
• To reduce respiratory motion on the CTAC and stabilize heart rate, have participant lie 
quietly for 2-3 minutes before acquiring scout image; 
• Participants will undergo a CT scan for attenuation correction (CT-AC) (50 mAs). Prior to 
acquiring each CT-AC, provide participant specific instructions to not take deep breaths 
during the CT-AC acquisition. This is to reduce respiratory motion on each CTAC. During 
the CT-AC scan, the participants will be instructed to perform normal end-expiration 
breath-holds;   
• After completion of the PET/CT study, alignment of the heart as seen on the PET and the 
CT images should be inspected. In the case of a misalignment, the heart should be 
re-aligned manually and image reconstruction repeated to ensure there are no artifacts of 
attenuation correction created by mis-registration of the CT and PET data. Images will 
be inspected by the technologists; 
• Prior to discharge from the CCIR to home or transfer to the CTRU, confirm participants’ 
contact information for the phone follow-up. Provide the participant study team contact 
information, (i.e., phone number) should an untoward reaction occur; 
• For all regadenoson stress PET MPI studies: 
o A physician (cardiologist) will be present; 
o Obtain 12-lead ECG, BP and HR pre and post regadenoson injection. 
o Obtain BP and HR every minute for at least 10-min post regadenoson injection and 
monitor ECG rhythm strip. 
o Aminophylline will be readily available to attenuate severe or persistent adverse 
reactions. Administer slow intravenous injection (50 mg to 100 mg over 30 to 60 
seconds) at least 1-minute after radiotracer injection. 
6.3 
Dosimetry Group - PET/CT Imaging 
Healthy adult normal volunteers enrolled in the dosimetry group will come to the Center for 
Clinical Imaging Research (CCIR) facility, a Washington University facility, located on the 10th 
floor of Barnes-Jewish Hospital for screening and PET imaging.  
The following assessments and procedures will be performed: 
• VS, 12-lead ECG, safety labs, and a brief physical exam pre and post injection and prior to 
discharge from the CCIR to home or transfer to the CTRU as described above; 
• All required safety assessments prior to the administration of [68Ga]Galmydar and monitor 
ECG rhythm and HR as described above. Monitor ECG-rhythm and HR during imaging; 
• Administer an intravenous bolus injection of  8 mCi ± 20% (6.4‒9.6 mCi) with a mass of 
≤ 10 µg of [68Ga]Galmydar followed by a 10 mL normal saline flush; 
• Whole-body PET image acquisition from head to mid-thigh. Imaging of subjects will be at 
three time points spanning from immediately after injection up to 4-hours after 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 21 of 49 
[68Ga]Galmydar injection. A low-dose spiral CT scan (120 kVp, 50 mAs) will be obtained 
for attenuation correction. Begin whole-body PET image acquisition from the head to mid-
thigh immediately post [68Ga]Galmydar injection for 60-min and repeat at 2 hours and 4 
hours.  
6.4 
Rest/Stress Group - PET/CT Imaging 
On Imaging Day-1, all participants enrolled in the rest/stress group will come to the CCIR facility 
for < 24-hours for screening, pre and post rest/stress [68Ga]Galmydar PET MPI safety assessments.  
On Imaging Day-2, all participants will report directly to the CCIR facility for the rest/stress 
13N-Ammonia PET MPI. [68Ga]Galmydar and 13N-ammonia imaging visits will be separated by a 
minimum of 3-days and not before the follow-up phone call is complete for capturing participant 
adverse events following the administration of 68Ga-Galmydar. 
In some instances, participants may be split the Day-1 imaging into two visits and complete a Day-
3 study. Therefore, on imaging Day-1, participants enrolled in the rest/stress group will come to 
the CCIR for screening, pre [68Ga]Galmydar PET MPI safety assessments and the rest imaging. 
On Day-2 participants will return to the CCIR for their stress imaging and post  [68Ga]Galmydar 
PET MPI safety assessments. On Imaging Day-3,  participants will report to the CCIR facility for 
the rest/stress 13N-Ammonia PET MPI. 
6.4.1 Imaging Day-1, Rest/Stress [68Ga]Galmydar PET MPI 
6.4.1.1 Rest [68Ga]Galmydar PET 
• Perform all required safety assessments pre-injection of [68Ga]Galmydar and monitor ECG 
rhythm and HR as described above. Obtain baseline VS and ECG (BP, HR, and RR) within 
15-min [68Ga]Galmydar pre-injection;   
• Administer an intravenous bolus injection of 4 mCi ± 20% (3.2‒4.8 mCi) with a mass of 
≤ 10 µg of [68Ga]Galmydar followed by a 10 mL normal saline flush. 
• Begin up to a 30-min list-mode data acquisition for a single bed position at the level of the 
heart immediately post-injection; 
• Remove subject from the scanner. Transfer participant to CTRU for a break. 
• The interval between the rest and stress [68Ga]Galmydar PET acquisitions should be no 
less than 2 hours and no greater than 4 hours.  
6.4.1.2 Stress [68Ga]Galmydar PET 
• Perform all required safety assessments pre-injection of regadenoson and [68Ga]Galmydar 
as described above. Monitor ECG rhythm and HR continuously during the PET scan; 
• Administer a rapid (10-sec) regadenoson intravenous injection (0.4 mg/5 mL), followed by 
5 mL saline flush; 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 22 of 49 
• 30-sec post regadenoson injection, administer a maximum intravenous bolus injection of  
6 mCi ± 20% (4.8-7.2 mCi) with a mass of ≤ 10 µg of [68Ga]Galmydar followed by a 10 
mL normal saline flush. If the same IV line is used for both the regadenoson and radiotracer 
injection, wait 10 to 20 seconds after the normal saline flush post regadenoson injection 
before injecting the radiotracer;  
• Begin up to a 30-min list-mode data acquisition for a single bed position at the level of the 
heart immediately post-injection; 
• Perform all required safety assessments post-injection of 68Ga-Galmydar, end of imaging 
and prior to discharge from the imaging facility as described above; 
• Transfer participant to CTRU for post imaging assessments and procedures prior to 
discharge as described above. 
6.4.2 Imaging Day-2, Rest/Stress 13N-Ammonia PET MPI 
[68Ga]Galmydar and 13N-ammonia imaging visits will be separated by a minimum of 3-days but 
not before the participant follow-up phone call is complete for capturing adverse events following 
the administration of 68Ga-Galmydar. Participants will report to the CCIR.  The PI, study 
cardiologist or trained designee will evaluate symptomatic patients to confirm there has been no 
change in clinical status since the [68Ga]Galmydar PET MPI. If in the judgment of the 
investigator/designee the patient’s clinical condition has changed since the [68Ga]Galmydar 
imaging day, the patient may undergo the rest only 13N-ammonia PET imaging scan or be 
rescheduled for Imaging Day-2, 13N-ammonia PET MPI. 
6.4.2.1 Rest 13N-Ammonia PET 
• Review of concomitant medications and any changes in health between the rest/stress PET 
MPI imaging day-1, 68Ga-Galmydar, and imaging day-2, 13N-ammonia; 
• Confirm a negative urine pregnancy test for women of childbearing potential; 
• Obtain baseline vital signs (BP and HR) pre and post 13N-ammonia injection as described 
above. Continue to monitor ECG-rhythm and HR until imaging is completed; 
• Administer an intravenous bolus injection of 10 mCi ± 20% (8‒12 mCi) of 13N-ammonia 
followed by a 10 mL normal saline flush. 
• Begin a 10-min list-mode data acquisition (if the anterior-posterior diameter of the chest is 
>50cm increase to 15-min) for a single bed position at the level of the heart immediately 
post-injection; 
• Obtain vital signs (BP and HR) and 12-lead ECG as required per clinical protocol; 
• Remove patient from scanner for a break. The interval between the rest and stress 
13N-ammonia acquisitions should be per the clinical protocol (no less than 1-hour).  


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
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6.4.2.2 Stress 13N-Ammonia PET 
• Obtain baseline vital sign measurements and 12-lead ECG pre-injection of regadenoson or 
13N-ammonia administrations. Continue to monitor ECG-rhythm, and HR, until stress PET 
MPI is completed; 
• Administer regadenoson intravenous injection (0.4 mg/5 mL) over 10 sec, followed by 
5-10 mL saline flush; 
• Obtain vital signs (BP and HR) and 12-lead ECG as required per clinical protocol; 
• 30 sec post regadenoson injection, administer an intravenous bolus injection of 10 mCi ± 
20% (8‒12 mCi) of 13N-ammonia followed by a 10 mL normal saline flush. If the same IV 
line is used for both the regadenoson and radiotracer injection, wait 10 to 20 seconds after 
the normal saline flush post regadenoson injection before injecting the radiotracer;  
• Begin a 10-min list-mode data acquisition (if the anterior-posterior diameter of the chest is 
>50cm increase to 15-min) for a single bed position at the level of the heart immediately 
post-injection; 
• Obtain vital signs (BP and HR) as described above prior to discharge.  
7 
SAFETY ASSESSMENTS 
Safety will be evaluated by monitoring changes from screening or baseline assessments in vital 
signs, physical findings, electrocardiograms, clinical laboratory tests values, and the incidence of 
adverse events (AE). AEs will be reviewed for potential significance and clinical importance.  
7.1 
Clinical Laboratory Tests 
The Department of Laboratories, Barnes-Jewish Hospital, is an accredited and Clinical Laboratory 
Improvement Act (CLIA) certified lab that will perform all laboratory blood tests for this study. A 
list of the current established reference ranges are available on the General Information page of 
the Barnes-Jewish Hospital (BJH) Lab website, https://bjhlab.testcatalog.org/.  
All participants will have baseline blood and urine samples obtained for screening and for 
comparison with post-imaging complete blood count, comprehensive metabolic panel, and 
urinalysis. For abnormal changes from baseline, the Investigator or designee will determine if 
additional assessments for clinical significance or change in participant management if needed. 
Any adverse events/serious adverse events must also be documented in the case report forms 
(source documents) and appropriately reported. 
Participants may request to receive a copy of their lab results or their rest/stress 13N-Ammonia 
PET MPI results to become part of their medical record at Barnes-Jewish Hospital. 
7.2 
Vital Sign Measurements 
Vital sign (VS) measurements will be obtained at screening to determine eligibility, at baseline 
within 60-min, within 15-min pre-injection and within 5 min, 15-min, and hourly post-injection of 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 24 of 49 
68Ga-Galmydar, and end of imaging prior to discharge. VS measurements may be repeated as 
needed. Follow standard-of-care stress regadenoson and rest imaging clinical protocol for the N-
ammonia imaging. VS measurements include heart rate (HR), systolic and diastolic blood pressure 
(BP), respiratory rate (RR), and body temperature. Temperature will be taken at baseline and prior 
to discharge on imaging days and as needed. Time points listed may only include BP and HR; see 
Imaging PET Assessments section for details. BP and HR must be obtained at least once prior to 
injection and once post-injection before discharge with the participant in the supine position. Care 
will be taken to obtain subsequent recordings with the participant in the same position (supine or 
upright).    
 
The following variables are considered clinically significant if changes occur from baseline. A 
systolic BP of < 90 or > 160 mmHg or a diastolic BP of < 50 or > 100 mmHg or a 20 mmHg change 
from baseline in the SBP or DBP. A heart rate of < 50 BPM or > 100 or a 20 BPM change from 
baseline. A respiratory rate of < 12 or > 20 breaths/min and oral temperature of >100oF.  
 
Participants who develop bradycardia (heart rate < 40 BPM, Mobitz 2:1 AV Block (Type 1 or 
Type 2) or QTc ≥ 500ms) will be monitored until heart rate and conduction returns to baseline. Any 
abnormalities that meet the definition of an adverse event/ serious adverse event must be 
documented and appropriately reported. 
7.3 
12-lead electrocardiogram  
A standard 12-lead electrocardiogram (ECG) will be obtained at screening for all participants. 
Baseline is within 60-min pre-injection, within 5-min post-injection, and prior to discharge, and 
repeated as needed. For the Rest/Stress group, ECGs will be obtained per standard-of-care 
rest/stress regadenoson imaging clinical protocol. A study cardiologist delegated by the PI will 
review and interpret the ECG, sign, and date.   
 
The following variables are considered abnormal if changes occur from baseline. A PR interval of 
<120 or >200 msec, QRS interval <50 or >100 msec, RR interval  <600 or >1000 msec, or QT 
interval ≥500 msec. Participants who develop second or third degree AV block and/or 
QTc  ≥500  post-injection, will be monitored until the ECG returns to normal and will be excluded 
from additional study procedures. Any abnormalities that meet the definition of an adverse event/ 
serious adverse event must be documented and appropriately reported. 
7.4 
Follow-up 
Study staff will contact dosimetry and rest/stress participants by phone following the administration 
of [68Ga]Galmydar to confirm the subject’s well-being and to ascertain if an adverse event (AE) 
occurred post-imaging procedures. If any of the specified days are not business days, the phone 
call may occur the following business day. In the event of a serious AE or unanticipated problem, 
we will ask participants to return to the imaging facility for evaluation/safety visit. Follow-up may 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 25 of 49 
consist of an in-person visit(s) or additional telephone contact. Study staff may access medical 
records during the study to follow AE/problems that developed because of study participation. We 
will follow all participant AEs until resolution or stabilization, as evaluated by the PI or designee. 
Study participation is complete at the end of the follow-up or the ﬁnal monitoring visit of serious 
AEs. 
7.4.1 Dosimetry group 
Dosimetry subjects will receive a phone call within 2-3 days and repeated at 5-7 days or as late as 
14 days post [68Ga]Galmydar injection.  
7.4.2 Rest/Stress group 
Rest/stress participants will receive a phone call within 2-3 days post [68Ga]Galmydar injection. 
The follow-up phone call to collect safety data must be complete before scheduling a participant 
for the rest/stress 13N-ammonia PET imaging visit. 
8 
IMAGE PROCESSING AND ANALYSIS 
8.1 
Rest Stress Group 
8.1.1 PET Images 
All images will be reconstructed at 5-min (a delay to allow for blood-pool clearance) using 
reconstruction matrix at 168 × 168 × 109, with a pixel size (2 × 2 × 2 mm). Scatter, decay, and 
random corrections will also be applied to the reconstructed images. Static myocardium perfusion 
and gated myocardial function images will be generated by skipping the first 5 minutes of the list 
mode data acquisition. Dynamic image sequence will be reconstructed for quantitative blood flow 
evaluation. Comparative quantitative blood flow will be evaluated with Carimas and also using 
QPET or 4DM software65 available through our departmental image processing servers 
(MIM/Vista and Hermes). Myocardial image processing techniques will then be applied to the 
gated datasets. The myocardial wall segment analysis will be performed using the 17-segment 
American Heart Association model66.  
8.1.2 MPI Interpretation  
All images will be interpreted and blindly scored by a board certified radiologists (Drs. Schindler, 
Woodard, and Gropler) in nuclear medicine. Both overall qualitative diagnosis and semi-
quantitative 17 segment with 5 point (0=normal, 4=absent tracer uptake) scoring will be employed 
in the independent blind read out by 3 expert radiologists in PET MPI interpretation. To maintain 
consistency, the same three readers will interpret all PET studies in independent reading sessions. 
Importantly, these readers will be blinded to type of radiotracer, the presence or absence of stress 
agent, and all clinically relevant data. Image quality will also be classified as excellent, good, fair, 
poor, or uninterpretable. For purpose of assessing diagnostic efficacy, each blinded reader will 
rate the rest/stress perfusion and gated images as normal, ischemic, ischemic and scar, or scar. A 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 26 of 49 
patient will be defined as MPI negative if the rating will be normal. Summed stress scores (SSS), 
summed rest scores (SRS), and summed difference scores (SDS) will also be calculated 64. 
Absolute regional myocardial blood flow will also be reported. 
8.1.3 Coronary Angiography Interpretation 
All coronary angiograms will be interpreted using quantitative coronary analysis (QCA).  Separate 
research analysis of the anonymized data will be performed. A coronary stenosis will be considered 
present when there is = 50% diameter stenosis in any epicardial coronary artery. The presence of 
one or more coronary stenosis will be used to define the presence of significant CAD. Presence or 
absence of wall motion abnormality will not be considered in interpreting the presence or absence 
of CAD. The determination of the presence or absence of CAD will be strictly related to coronary 
stenosis in the native coronary arteries; arteries with patent stents will be classified as no significant 
CAD, regardless of evidence of prior myocardial infarction. Arteries with bypass grafts but native 
coronary stenosis will be classified as significant CAD. 
8.1.4 Kinetic Modeling for Imaging Quantification to Calculate Myocardial Uptake, MBF, 
and Retention 
Carimas software incorporates the needed compartmental models suitable for this study. 
[68Ga]Galmydar MBF (at rest and stress) will be quantitatively analyzed using a 1-compartment 
tracer kinetic model as used previously for other mitochondrial targeted agents.52 The standard 1-
compartment model is governed by two rate constants: K1 represents activity from blood to 
myocardium, and is related to blood flow and K2 characterizes the activity from myocardium to 
the blood. In general, blood flow is related to K1 by a flow-dependent extraction fraction with a 
relationship of the form: K1 = EF (Extraction Fraction).MBF with EF = (1-exp(-(αMBF + β)/MBF) 
with α and β being tracer dependent parameters. Importantly, [13N]-NH3 is a validated quantitative 
blood flow tracer which will be modeled using the 2-compartment model described earlier. 
Further, [13N]-NH3 shows first pass extraction of 90% and will serve as a reliable reference control. 
In both of these models, the effects of partial recovery of the counts in the myocardium and spill-
over from the blood pool have been fitted along the model parameters.  
To investigate the relationship between the radiotracer extraction and flow, the tracer-derived MBF 
data will be plotted against both the absolute microsphere-derived MBF values and 13N-ammonia 
MBF values. This relationship will allow us to characterize the flow dependent extraction fraction 
for the radiotracer. We will first determine K1 from compartmental modeling and then determine 
the extraction fraction parameters (α and β) by relating [68Ga]Galmydar K1 to radioactive 
microsphere MBF and [13N]-NH3 derived MBF. We will then compare and analyze this extraction 
fraction to flow dependent extraction of other known MBF tracers, such as 99mTc-sestamibi, 
99mTc-Tetrafosmin, 201Tl or 82Rb. Furthermore, [68Ga]Galmydar excretes from blood pool much 
faster than 99mTc-sestamibi due to low logP value, and heart/blood (5min/60 min) ratios in mice 
are also superior to that of 18F-Flurpiridaz ([68Ga]Galmydar: %ID/g; 12.0/0.1= 120 REF; 
18F-BMS-747158: 9.5/0.5 = 1914; 120/19 = 6.3 folds), these data point to superior flow dependent 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 27 of 49 
extraction fraction of [68Ga]Galmydar than 99mTc-sestamibi. Furthermore, the MFR (myocardial 
flow reserve), which is defined as the ratio of maximal to basal MBF, will be compared between 
the myocardial retention (MFRretention) and SUV-derived data (MFRSUV) versus both either 
[68Ga]Galmydar MFR (MFRGalmydar) or 13N-Ammonia MFR (MFRAmmonia). Because myocardial 
perfusion will be homogeneous, only mean values in the left ventricle will be used in the analysis. 
These proposed experiments will allow us to accurately measure this factor in an animal model 
closer to an anatomical reference for application in humans thus providing modeling paradigms to 
enable quantification of the myocardial blood flow in humans. MBF will also be evaluated with 
clinically approved software such as QPET or 4DM software65 available through our departmental 
image processing servers (MIM/Vista and Hermes). 
9 
STATISTICAL PLAN 
Continuous variables will be expressed as mean (or median) and range or standard deviations. 
Categorical variables will be expressed as frequencies. The diagnostic efficacy of [68Ga]Galmydar 
and 13N-ammonia PET MPI will be assessed following blinded and independent reads of PET MPI 
data using ICA as the truth standard. Analysis of diagnostic efficacy will be performed by the 
reader. The analysis of diagnostic certainty will be a modified majority rule in which the median 
rating will be used when three readers have 3 different ratings. Similarly, summaries and 
comparisons of Summed Stress Score (SSS), the Summed Rest Score (SRS), and the Summed 
Difference Score (SDS) measures will use the median of the results of 3 blinded readers. The 
sensitivity and specificity and corresponding 95% confidence interval of each radiotracer will be 
reported. Normalcy rate will be determined in the patients with a low likelihood of CAD and no 
ICA and be calculated as % of patients with normal/probably normal studies. Agreement for the 
diagnostic efficacy (presence/absence of CAD) between [68Ga]Galmydar and 13N-ammonia PET 
MPI will be compared using a kappa statistic. The agreement between the quality of scan will be 
assessed using a weighted kappa and the SUV uptake will be assessed using an intra-class 
correlation coefficient. The ROC analysis will be performed using 17 segment model (according 
to the American Heart Association Guidelines) to assess the diagnostic efficacy in detection of 
obstructive coronary disease. The area under ROC and confidence intervals will use the empirical 
approach developed by DeLong, et al.68 The inter-reader agreement between 3 blinded readers will 
be estimated by comparison of dichotomized ratings (normal/abnormal) and presented using kappa 
and percent agreement. Intra-reader agreement in each of the reader will be performed by 
randomizing 10% of the repeat images in the blinded read and will be estimated using kappa and 
percent agreement. All tests will be two-sided and a significance level of 5%.  
9.1 
Sample size justification 
While information in humans is not available, our preliminary animal data shows high agreement 
between [68Ga]Galmydar and 13N-ammonia. Therefore, we expect to see strong agreement 
between the diagnostic efficacies of these two radiotracers in this sample of patients. A sample 
size of 20 patients results in a two-sided 95% confidence interval with a width of 0.26 (lower 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
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limit=0.669, upper limit=0.931) assuming strong agreement between the radiotracers (a kappa of 
0.8) and a standard deviation of 0.3. Sample size calculations were conducted in PASS v14. 
10 
REGULATORY AND SAFETY REPORTING 
10.1 
Regulatory Compliance 
The Sponsor-Investigator and Principal Investigator will conduct the protocol in adherence to the 
guidelines set forth by the Institutional Review Board (IRB) /Human Research Protection Office 
(HRPO) and the Radioactive Drug Research Committee (RDRC)/Radiation Safety Office at 
Washington University and the U.S. Food and Drug Administration (FDA). The Sponsor-
Investigator will ensure members of the research team will comply with the adverse event 
reporting as described below. 
The Principal Investigator, Sponsor-Investigator, Authorized User, and members of the research 
team will promptly review all available safety information relevant to the safety of the drug, 
including any ﬁndings from another source not related to this study that suggest a significant risk 
for human subjects. Subjects will be instructed to inform a member of the research team as soon 
as possible should they experience symptoms of an adverse event to begin an adverse event 
evaluation. AE follow-up will occur as ordered by the Principal Investigator or designee. 
Additional follow-up will occur until the abnormal measurements return to baseline or acceptable 
limits, or until monitoring is no longer warranted or stabilization as evaluated by a physician. A 
study team member will review the subject’s medical record for clinical history and, if applicable, 
monitor for test results as made available.   
10.2 
Safety Event Definitions 
For this study, the following standard definitions for reporting will be used: 
10.2.1 Investigational Drug 
The investigational drug named [68Ga]Galmydar is a radioactive drug held under an Investigational 
New Drug (IND) application.  
10.2.2 Adverse Event  
Adverse Event (AE) is any untoward medical occurrence in human subjects who receive the 
investigational radioactive drug 68Ga-Galmydar, whether or not considered related to the drug. An 
AE (also referred to as an adverse experience) may include any unfavorable and unintended sign 
(i.e., abnormal lab test finding), symptom, or disease temporally associated with the use of the 
drug, and does not imply any judgement about causality.  
10.2.3 Suspected Adverse Reaction 


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Galmydar Protocol 
Version 4.1, 2022-12-06 
 
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A suspected adverse reaction is any adverse event that is determined that there is a reasonable 
possibility that the investigational drug caused the adverse event. For IND safety reporting, 
'reasonable possibility' means there is evidence to suggest a causal relationship between the drug 
and the adverse event. A suspected adverse reaction implies a lesser degree of certainty about 
causality than an adverse reaction. 
 
 
 
10.2.4 Adverse Reaction  
Adverse Reaction means any adverse event caused by the investigational drug. Adverse reactions 
are a subset of all suspected adverse reactions where there is a reason to conclude that the drug 
caused the event. 
10.2.5 Serious Adverse Event 
An adverse event or suspected adverse reaction is considered serious if the event or reaction, in 
the view of the Principal Investigator, results in any of the following serious outcomes: 
• Death,  
• A life-threatening adverse event as defined as placing the participant at immediate risk of 
death from the AE as it occurred,  
• Initial or prolonged inpatient hospitalization (hospital admission defined as ≥ 24 hours or 
prolongation of a hospital stay due to adverse event),  
• Persistent or significant incapacity or substantial disruption of the ability to conduct normal 
life functions, or 
• Congenital anomaly or birth defect.  
10.2.6 Life-threatening 
An adverse event or suspected adverse reaction is “life-threatening” if, in the view of the Principal 
Investigator, its occurrence places the participant at immediate risk of death. It does not include an 
adverse event or suspected adverse reaction that, had it occurred in a more severe form, might have 
caused death. 
Important Medical Events (IMEs) are not immediately life-threatening, nor do they place a 
participant at immediate risk of death or require hospitalization. Examples of IMEs include allergic 
bronchospasm requiring intensive treatment in the emergency room or at home, or convulsions 
that do not result in inpatient hospitalization. IMEs may be serious if in the judgement of the 
Principal Investigator or designee they require medical or surgical intervention to prevent one of 
the above serious outcomes.  


Drug: [68Ga]Galmydar 
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 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
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10.2.7 Unexpected 
An adverse event or suspected adverse reaction is unexpected if is not listed at the specificity or 
severity that is currently 
 observed, or the event is not consistent with the risk information described in the protocol, 
informed consent form, general investigational plan or elsewhere in the current IND application. 
An Investigator's Brochure does not exist nor is it required for this IND.  The Principal Investigator 
or designee will determine if an adverse event is unexpected. 
Expected adverse reactions are adverse events that are known to occur for the investigational drug 
and should be collected in a standard, systematic format using a severity grading scale. 
Expectedness is assessed based on the awareness of AEs previously observed, not on the basis of 
what might be anticipated from the properties of the study drug. For risk related to this IND 
protocol, see Expected Risks section below.  
10.3 
Causality and Severity Assessment  
The Principal Investigator or designee will make a clinical determination as to the likelihood that 
an AE is related to the administration of the radioactive drug or research visit procedure. Other 
etiologies such as pre-existing conditions, concomitant therapy, study-related procedures, 
accidents that occur while on study, and other external factors will be considered during the 
evaluation of relatedness.  
Pre-existing Conditions that are present at the time of informed consent will be considered 
participant baseline. All baseline conditions will be recorded on the medical history in the source 
document forms. Worsening of the severity or frequency of a pre-existing condition in a research 
participant which does not necessarily have a causal relationship with the investigational drug is a 
reportable adverse event. Any changes, i.e., deterioration or worsening in these condition(s) shall 
be documented and evaluated by the Principal Investigator or designee. AEs with signs and 
symptoms that are believed to be due to the pre-existing condition(s) will not be reported as an AE 
unless there is an increase in frequency and severity.  
10.3.1 Severity/Intensity 
An adverse event will be classified as one of the following to describe the severity (intensity) and 
any necessary action taken in an attempt to resolve the event:  
• Mild: A mild AE is usually transient in nature and generally not interfering with normal 
activities. Participants are asymptomatic or have mild symptoms; intervention is not 
indicated. 
• Moderate: A moderate AE is sufficiently discomforting to interfere with normal daily 
activities. Participants may need minimal, local, or noninvasive intervention;  


Drug: [68Ga]Galmydar 
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 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
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• Severe: Also referred to as medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization is indicated; disabling; limiting self-care 
activities of daily living (ADL). Note that a severe event is not necessarily a serious event. 
10.3.2 Attribution 
The degree of certainty about causality will be graded using the following relationship categories: 
• Unrelated: An adverse event is clearly not related to the drug or procedure.  
• Unlikely Related: An adverse event is doubtfully related to the drug procedure.  
• Possibly Related: An adverse event is may be related to the drug or procedure.  
• Probably Related: An adverse event is likely related to the drug or procedure.  
• Definitely Related: An adverse event is clearly related to the drug or procedure.  
For the purposes of regulatory reporting, a causality assessment of unlikely related will be 
managed as “unrelated.” An adverse event that is definitely, probably, or possibly related will be 
managed as “related” and considered a “reasonable possibility” that the drug caused the adverse 
event and, therefore, meets the criteria for reporting to the FDA. 
10.4 
Documenting Adverse Events  
All serious and non-serious adverse events as well as abnormal test results/findings, regardless of 
suspected causal relationship will be documented in the subjects’ research record. Complete 
appropriate reporting forms according to the guidelines set forth by the Institutional Review Board 
(IRB) at Washington University Human Research Protection Office (HRPO) and the U.S. Food 
and Drug Administration (FDA).  
Adverse events that are classified as reportable will be followed until resolution or stabilization as 
evaluated by a physician. Any new relevant clinically significant findings/abnormalities or 
changes from the subjects’ baseline that meet the definition of an adverse event must also be 
recorded and documented as an adverse event. All clinically significant changes, relevant medical 
history and concomitant medications and action taken will be documented in the subjects’ case 
report forms (source document forms). Events that which do not meet the requirements of SAE 
reporting will be reviewed and confirmed by the Investigator and reported with the IRB annual 
continuing review, Data Safety and Monitoring report and the FDA annual report.  
The investigator’s clinical determination of any adverse event will be recorded and maintained in 
the subjects’ research record. All AEs shall be documented on the adverse event log maintained in 
the regulatory binder. 
10.5 
Food and Drug Administration Mandatory Reporting 
The Principal Investigator and Sponsor Investigator will promptly review all study information 
relevant to the safety of the drug obtained or otherwise received from any source, foreign or 
domestic, including information derived from clinical investigations, animal investigations, 


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commercial marketing experience, reports in the scientific literature, and unpublished scientific 
papers. The Principal Investigator and Sponsor Investigator will identify previously reported 
similar adverse events in IND safety reports and analyze the significance of the current event in 
light of the previous reports. 
The Sponsor-Investigator must notify the Food and Drug Administration (FDA) of any adverse 
events that are observed or voluntarily reported according to the reporting criteria and timeframe 
as described below.  
10.5.1  “7-day” Reportable Events  
Report any study event that is serious (fatal or life-threatening), unexpected, and associated with 
the use of the investigational drug. Report as soon as possible but no later than 7-calendar days 
following the Sponsor-Investigator/ Principal Investigator’s initial receipt of the information. 
Identify the submission as “7-day IND Safety Report.” 
10.5.2 “15-day” Reportable Events  
Report any study event that is serious, but not fatal or life-threatening, unexpected, and associated 
with the use of the investigational drug. Other findings that suggest significant risk to human 
subjects, any clinically important increased rate of events or any previous unreported adverse event 
that was not initially reportable because the event did not fit the criteria for reporting. Report within 
15-calendar days from when Sponsor-Investigator/Principal Investigator’s initial receipt of the 
information or determination of the previous event is currently reportable. Identify the submission 
as “IND Safety Report.” 
10.5.3 Follow-up Reporting 
The Sponsor-Investigator/ Principal Investigator will report any additional information that 
pertains to an IND safety report previously submitted. Any relevant follow-up information that 
pertains to an IND safety report previously submitted will be submitted within 15-calendar days 
from day zero, date of the 7-day report. Identify the submission as “Follow-up IND Safety Report.” 
10.5.4 Annual Report 
A summary of all IND safety reports, including the most frequent and most serious AEs, will be 
submitted each year within 60 days of the anniversary of the date that the IND became active, the 
date clinical studies were permitted to begin. 
10.5.5 Reporting Events to the FDA  
IND safety reports may be submitted electronically on an FDA Form 3500A (MedWatch) or in a 
narrative format via secure e-mail, facsimile transmission or telephone to the FDA Regulatory 
Project Manager in accordance with 21 CFR 312.32 to the address below.  
Division Director 


Drug: [68Ga]Galmydar 
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 Exploratory Investigational New Drug Application 
Galmydar Protocol 
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U.S. FDA CDER - Division of Medical Imaging Products 
Attention: FDA Central Document Room 
5901-B Ammendale Road 
Beltsville, MD 20705-1266 
FAX: 301-796-9899 
10.6 
Institutional Review Board Mandatory Reporting 
The Principal Investigator or designee will report to the Institutional Review Board (IRB) at 
Washington University (WU) and the Human Research Protection Office (HRPO) in accordance 
with WU IRB policies and procedures. The Investigator or designee will report immediately to the 
IRB any observed or volunteered self-reported adverse event that meets the unanticipated problem 
criteria or if the Investigator believes, the information meets the exception criteria as described 
below. 
10.6.1 IRB/HRPO Definitions 
10.6.1.1 
Unanticipated Problem (UP) involving risks to participants or others:  
• Are unexpected in terms of nature, severity, and/or frequency given the research 
procedures that are described in the protocol and consent form and the characteristics of 
the subject population being studied; and 
• Are related or possibly related to participation in the research; and  
• Suggest that the research places participants or others at a greater risk of harm including 
physical, psychological, economic, or social harm, than previously known or recognized. 
10.6.1.2 
Unexpected adverse drug event:  
Any adverse drug experience, associated with the use of the drug, of which the frequency, 
specificity, or severity is not consistent with the current investigator brochure; or, if an investigator 
brochure is not required or available, the specificity or severity of which is not consistent with the 
risk information provided to the participants and the IRB. 
10.6.1.3 
Protocol Exceptions and Deviations 
• Protocol exceptions apply only to a single participant or a singular situation. The IRB is 
required to review and approve a planned protocol change before initiation or 
implementation of a change, except when necessary to eliminate immediate hazards to a 
participant. In the event a situation occurs which requires deviation from the protocol, the 
Principal Investigator or designee will make the final judgement on whether a participant 
has completed the study. The PI should report the change after the occurrence as a 
reportable event within 10 working days. 
• Protocol deviations from the investigational plan or protocol that affect the life or physical 
well-being of a participant in any emergency, the Principal Investigator or designee will 
promptly notify the FDA and IRB as required. Deviations because of unforeseen 


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circumstances, .e.g., low yield tracer production, technical problems with a scanner, or 
participant unable to complete the full imaging protocol will not result in cancellation of 
the scan and is not reportable as a protocol deviation. Data analysis will account for a 
shorter imaging protocol. The Authorized User verbally approves a dose variance before 
the administration of a low dosage that is outside the approved allowable range. A shorter 
imaging protocol or dose variance will be documented in the participant research record, 
but will not be reported as a protocol deviation. 
10.6.1.4 
Non-Compliance and Serious Non-Compliance 
• Noncompliance may occur due to lack of knowledge or due to deliberate choice to ignore 
regulations, institutional policies, or determinations of the IRB. Noncompliance is the 
failure to follow any applicable regulation or institutional policies that govern human 
subjects research or failure to follow the determinations of the IRB.  
• Serious noncompliance is noncompliance that materially increases risks that results in 
substantial harm to subjects or others, or that materially compromises the rights or welfare 
of participants. 
10.6.2 Reporting Events to IRB/HRPO  
Table 1 is a summary of reportable events that do not meet the unanticipated problem definition 
will be reported with the IRB annual continuing review, i.e., IND external safety reports. Federal 
regulations do not require immediate reporting to the IRB of IND/outside safety reports for events 
that do not meet the criteria outlined in 21 CFR 312.32(c). Thus, IND Safety reports that do not 
meet the regulatory requirement for immediate reporting will be reported in an aggregate summary 
format at the time of IRB continuing review. 
10.6.2.1 
“1-day” Reportable Events 
The Principal Investigator or designee will promptly notify the IRB of the events below within one 
working day of the occurrence or notification of the event to the PI or a member of the research 
team.  
• Any unanticipated problem involving risk to participants or others and results in the death 
of a participant at WU. 
• An unexpected adverse drug event that results in the death of a participant at WU. 
• A major deviation that results in the death of a participant at WU. 
10.6.2.2 
“10-day” Reportable Events 
The Principal Investigator or designee will promptly notify the IRB of the events below within 
10 working days of the occurrence or notification of the event to the PI or a member of the research 
team.  


Drug: [68Ga]Galmydar 
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Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 35 of 49 
• An unanticipated problem involving risk to participants or others, or a major deviation that 
does NOT result in the death of a participant at WU. 
• A series of minor deviations that represent a systemic issue with the conduct of the study. 
• New information that may influence the willingness of subjects to participate in the 
research study, e.g., an interim analysis or safety monitoring report that indicates the 
frequency or magnitude of harms or benefits, or a paper published from another study that 
shows a difference in risks or potential benefits. 
• Participant complaints that result from an unanticipated problem or noncompliance. 
• Breach of confidentiality 
• Incarceration of a participant enrolled in the protocol  
• Withdrawal of the participant poses a safety issue 
10.7 
Reporting to Radioactive Research Drug Committee 
According to applicable policies of the Radioactive Research Drug Committee (RDRC) at 
Washington University (WU), the Sponsor-Investigator/ Principal Investigator or designee will 
notify the RDRC of any excessive radiation exposure or serious adverse reaction to the radioactive 
drug within 24 hours to the Chairman of the RDRC. 
10.8 
Timeframe for Reporting Required Events 
Table 1 below summarizes the timeframe requirements for reportable events after initial receipt of 
the information by the Sponsor-Investigator (Vijay Sharma, Ph.D.), Principal Investigator (Pamela 
K. Woodard, M.D.), Authorized User (Thomas Schindler, M.D.), and Sub-Investigators, or a 
member of the research team as described above.  
 
 
 
 
 
 
 
 
 
 
 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 36 of 49 
 
 
 
Table 1 - Reportable Events 
IRB and RDRC REPORTING 
FDA REPORTING 
• Any unanticipated problem 
involving risk to participants or 
others and results in the death 
of a participant. 
• An unexpected adverse drug 
event that results in the death of 
a participant. 
• A major deviation that results in 
the death of a participant. 
The PI will report to 
the IRB and the AU 
will report to RDRC 
within “1-working 
day”. 
• Any serious (fatal or 
life-threatening), 
unexpected suspected 
adverse reactions.  
 
The IND Sponsor-
Investigator will report 
to the FDA as soon as 
possible but no later than 
“7-calendar days” 
following initial receipt 
of the information. 
• An unanticipated problem 
involving risk to participants or 
others, or a major deviation that 
does not result in the death of a 
participant.  
• New information that may 
influence the willingness of 
participants to take part in the 
study, e.g., an interim analysis 
or safety monitoring report that 
shows the frequency or 
magnitude of harms or benefits, 
or a published paper from 
another study that shows a 
difference in risks or potential 
benefits, revised Investigator’s 
Brochure (IB), FDA labeling 
change, a marketing drug 
withdrawal, or DSMB reported 
safety issue. 
• A series of minor deviations 
that represent a systemic issue 
with the conduct of the study.  
• Participant complaints that 
result from an unanticipated 
problem or noncompliance. 
• Breach of confidentiality. 
• Participant withdrawal poses a 
safety issue. 
• Incarceration of an enrolled 
participant. 
The PI will report to 
the IRB and the AU 
will report to RDRC if 
deemed reportable 
within “10-working 
days”. 
• Any serious, 
unexpected, 
suspected adverse 
reactions.  
• Findings from other 
clinical, animal, or in-
vitro studies that 
suggest significant 
human risks. 
• Any clinically 
important increased 
rate of serious 
suspected adverse 
reaction. 
The IND Sponsor-
Investigator will report 
to the FDA and all 
investigators within 
“15-calendar days” 
after determining the 
information qualifies for 
reporting.  
• Adverse events that do not meet 
the definition of unanticipated 
problem.   
 
The PI will include an 
adverse event 
summary in the IRB 
annual continuing 
review. 
• Adverse events that 
do not meet the 
definition of serious, 
unexpected, and 
suspected adverse 
reaction.   
The IND Sponsor-
Investigator will include 
a summary of adverse 
events in the FDA 
annual report. 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
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• External IND Safety reports 
(non-WU) for a cross-
referenced IND drug that does 
not meet the above reporting 
requirements.  
The PI will include a 
summary of external 
IND Safety reports in 
the IRB annual 
continuing review. 
• Adverse events that 
do not meet the 
definition of serious, 
unexpected, and 
suspected adverse 
reaction.   
The IND Sponsor-
Investigator will include 
a summary of external 
IND Safety reports in the 
FDA annual report. 
 
11 
EXPECTED RISKS 
11.1 
[68Ga]Galmydar Risks 
We consider the risk associated with an investigational new PET radioactive drug extremely low 
based on the short half-life of [68Ga]Galmydar of 68 minutes, the prescribed dosage is at the 
required microdose level, and observations made from the preclinical toxicity studies that no 
histopathologic changes were attributable to drug toxicity nor were there abnormalities attributable 
to the single drug dose. Despite this, there is nevertheless the possibility of a rare allergic reaction. 
See IND application appendices for the toxicity report. 
Based on common responses to other tracers, we anticipate that some participants may experience 
dysgeusia (bad taste in mouth), flushing, headache, dizziness or lightheadedness, mild 
gastroenteritis, pruritus, urticaria. 
11.2 
13N-Ammonia Risks 
13N-Ammonia is an FDA approved drug. There are no known side/adverse effects associated with 
the use of 13N-Ammonia other than radiation exposure. 
11.3 
Radiation Exposure 
Participants will be exposed to radiation from 68Ga-Galmydar, 13N-ammonia, and low-dose 
computerized tomography (CT) imaging conducted on the Vision Edge PET/CT or Biograph-40 
TruePoint PET/CT scanner. The effective dose (ED) calculations are for worst-case scenarios 
depending on the number of CT-attenuation correction (CT-AC) scans with topogram. An 
additional CT-AC scan with topogram will be performed for participants who may need to be 
rescheduled due to technical problems, e.g., scanner issues, radiotracer failure, or for participants 
who require a break during a scan and resume imaging after the break. The risk associated with 
the amount of radiation exposure participants receive during this research study is low and 
comparable to other everyday risk.  
11.3.1 Low-dose CT  
The effective dose (ED) for one whole-body CT protocol conducted at a single time point is 0.49 
rem (50 mAs). A one-bed position low dose CT (50 mAs) over the heart for attenuation correction 
(CT-AC) is 0.18 rem.  


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 38 of 49 
11.3.2 [68Ga]Galmydar and 13N-Ammonia PET  
The effective dose for [68Ga]Galmydar is 0.103 rem/mCi (gender averaged). The effective dose 
for 13N-ammonia is 0.007 rem/mCi. 
 
11.3.2.1 
Dosimetry Group 
A single dosage of 8 mCi ± 20% (6.4‒9.6 mCi) with a mass of ≤ 10 µg is planned for 
[68Ga]Galmydar administration for the Dosimetry group. The effective dose for a whole-body 
PET/CT imaging protocol includes a single intravenous administration of 8 mCi of 
[68Ga]Galmydar, three whole-body CT scans and four CT-AC scans is 2.81 rem and 2.87 rem for 
male and females. 
11.3.2.2 
Rest/Stress Group 
Participants will receive two [68Ga]Galmydar intravenous administrations, 4 mCi during rest and 
6 mCi during stress for the PET MPI performed on Imaging Day-1. The effective dose for a single 
intravenous administration of 6 mCi of [68Ga]Galmydar is 0.62 rem and 0.41 rem for a 4 mCi 
administration performed. The acceptable mass of [68Ga]Galmydar is ≤ 10 µg per administration. 
On Imaging Day-2, participants will receive two single administrations each of 10 mCi of 13N-
Ammonia during the rest and stress PET MPI. 
 
• Rest/Stress [68Ga]Galmydar PET MPI 
The effective dose for a rest and stress PET MPI study includes an intravenous 
administration of 4 mCi during the rest PET and an 6 mCi administration during the stress 
PET MPI, and two CT-AC scans with topogram is 1.40  rem. 
• Rest/Stress 13N-Ammonia PET MPI 
The effective dose for a single intravenous administration of 10 mCi of 13N-Ammonia is 
0.07 rem. The effective dose for a rest/stress 13N-Ammonia PET MPI study includes two 
administrations each of 10 mCi of 13N-Ammonia and two CT-AC scans is 0.51 rem. 
• Total Rest/Stress PET MPI  
The total effective dose for Imaging Day-1, rest/stress [68Ga]Galmydar PET MPI and 
Imaging Day-2, rest/stress 13N-Ammonia PET MPI study is 1.91 rem. This includes one 
administration each of 68Ga-Galmydar, 4.0 mCi during rest and 6 mCi during stress, and 
two CT-AC scans and two administrations each of 10 mCi of 13N-Ammonia and two CT-
AC scans. 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 39 of 49 
11.4 
Regadenoson  
Regadenoson, the pharmacological stress agent may cause a flushed feeling during the intravenous 
injection. After injection of regadenoson, mild headache, nausea, or dizziness, an irregular and/or 
fast heartbeat, shortness of breath, mild chest pressure or chest pain may ensue for a short while. 
If needed as prescribed by the study doctor (cardiologist), intravenous aminophylline may be given 
to resolve these side effects. 
11.5 
PET/CT Imaging Scanner 
Other risks may include feeling uncomfortable while lying down during the scan. Participants may 
experience claustrophobia (anxiety due to being restrained in a confined area) while some 
experience dizziness or feel faint. If the participant experiences these symptoms and does not wish 
to continue, the study will be stopped immediately. 
There is a rare risk of malfunction of worn or implanted electronic medical devices during the low-
dose CT attenuation scan conducted prior to the PET scan. Participant screening of such devices 
will be performed by the investigator or designee and trained research staff. The CT scan may 
cause a malfunction of worn or implanted electronic medical devices, i.e., pacemaker or a drug 
pump. 
11.6 
Intravenous Catheter Placement 
Participants may experience pain, bruising, and/or bleeding at the site of needle insertion for the 
intravenous (IV) catheter.  There is a rare risk of infection from the needle insertion. 
11.7 
Questionnaires 
Participants may experience emotional discomfort when answering some questions in the 
questionnaires (i.e., PET/CT safety screening assessments). If any particular question makes the 
participant uncomfortable, the participant may discuss its importance and the need to answer it 
with a trained interviewer. Participants have the right to refuse to answer any question for any 
reason. If safety screening cannot be completed, the imaging exams will be canceled. 
11.8 
Breach of Confidentiality 
Disclosure of confidential information may occur accidentally during participation in this study. 
We will use our best efforts to keep the information about participants secure. All private 
information is stored in secured areas inside locked cabinets or on encrypted and password 
protected Washington University computers.  
A radiologist will review all CT scans. If there is a clinically meaningful abnormality identified or 
other medical need for sharing, workflows have been established for sharing the images and 
reports. The Principal Investigator or a designee communicates any potentially clinically 
meaningful abnormal findings to the participant and, if the participant permits, to their primary 


Drug: [68Ga]Galmydar 
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Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 40 of 49 
physician. If requested for clinical use, following hospital HIPAA policies, a copy of the CT scan 
and the report will be uploaded to the participant’s electronic health record (EHR). Once the CT 
is part of the EHR, then participants may request additional copies to be sent to additional 
physicians using a standard medical record request. 
11.9 
Other risks 
There may also be unknown risks. Although allergic or other immediate adverse reactions are not 
anticipated, participants will be monitored in an area where emergency equipment is available. 
There are no alternative methods to gather comparable data. 
12 
DATA SAFETY MONITORING PLAN 
In compliance with the Washington University School of Medicine Institutional Data Safety 
Monitoring (DSM) Plan, the PI will provide a DSM report to the IRB/HRPO annually. All 
members of the research team will review safety data as it becomes available. The DSM report 
will include, but not be limited to the protocol title, IRB protocol number, IND number, the 
activation date of the study, the number of subjects enrolled to date, a summary of all adverse 
events, number of subjects who dropped out/withdrew for any reason whether thought to drug 
related with a corresponding reason for dropout, and any new information related to the 
investigational drug or that may affect the safety or ethics of the study.  
Drs. Woodard (PI) and Wahl and the Sponsor-Investigator, and at least one additional sub-
investigator, will review and assess drug biodistribution and safety data through the 2-3 day post-
injection phone follow-up from the first two (2) normal volunteers prior to imaging of the 
remaining normal volunteers. Upon completion of the review, the study will continue with imaging 
of the remaining dosimetry subjects with simultaneous entry of the rest/stress group. 
Asymptomatic normal controls and symptomatic patients who have undergone a SPECT MPI 
examination that is normal or positive and prior to ICA intervention, will undergo a rest/stress 
[68Ga]Galmydar PET MPI and rest/stress 13N-ammonia PET MPI with a minimum of a 3-day 
separation.  
13 
DATA COLLECTION, RETENTION, AND DATA MANAGEMENT  
13.1 
Data Collection Forms 
Each participant will have a research chart with case report forms (source document forms) 
designed for documenting all observations and other pertinent study related activity. The research 
coordinator or designee will document eligibility criteria and other pertinent information such as 
demographic information, imaging visit sessions with pregnancy test results, if applicable and 
administration of radiopharmaceutical, adverse events and any in-person or correspondence with 
participants. 


Drug: [68Ga]Galmydar 
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Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
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13.2 
Records Management 
The Sponsor-Investigator/ Principal Investigator will maintain records in accordance with Good 
Clinical Practice Guidelines. The Investigator will delegate such tasks to research team members 
to ensure all study files are accurate and organized at all times. The study coordinator will review 
participant research records, including hard copy and electronic, for completion and accuracy. The 
study team will follow best practice guidance with implementation of electronic storage of research 
study documents. Electronic records may be created, maintained, and stored where possible. A 
certified copy of the signed informed consent form may be stored in a secure web-based data 
storage application that is HIPAA compliant. All electronic records are password protected in an 
electronic data capture system that is on a (the?) Washington University Secure Network and in 
compliance with university policies. Paper records that are required for the study will be stored 
under a 2-tiered locked system. 
Imaging Safety questionnaires and other imaging data required for radiation safety will be 
collected in accordance with the Code of Federal Regulations (21 CFR 312) procedures and 
requirements governing the use of investigational new drugs and the monitoring of serious adverse 
events per for the protocol to allow for oversight of annual radiation exposure of participants. We 
may share the data with other investigators if a participant takes part in future studies requiring 
imaging procedures. 
 
13.3 
Retention and Availability of Records 
The Sponsor-Investigator/ Principal Investigator will maintain records in accordance with 
standards of Good Clinical Practice, and applicable local institutional policies and procedures. IND 
records and reports will be retained for a minimum of 2 years after study discontinuation, or the 
FDA has been formally notified (21 CFR 312.57). Participants provide consent to authorization 
for the use of private health information. Therefore, all research records, including signed consent 
forms and data/case report forms (source documents) will be retained for at least seven, (7) years 
beyond the close of the study.  
The Sponsor-Investigator/ Principal Investigator will make study data and research records 
available for audit purposes and inspections if so requested by authorized representatives of 
Washington University Institutional Review Board, the Human Research Protection Office or 
Regulatory Agencies, i.e., Food and Drug Administration or National Institutes of Health, the 
source of grant funding. 
13.3.1 Archival of Imaging Data  
Only code numbers will appear on any data and documents to be used for evaluation or statistical 
analysis. Publications emanating from this research will not identify individual patients.  HIPAA 
compliance will be enforced as per Washington University policy and HRPO approval.  


Drug: [68Ga]Galmydar 
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 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
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Processed and raw PET/CT data will be transferred to the Central Neuroimaging Data Archive 
(CNDA). Request for access to CNDA must be reviewed and approved by the Principal 
Investigator or an engaged sub-investigator.  Data access is limited to approved user roles as well 
as assigned access privileges. CNDA complies with Section 164.310 of the Health Information 
Portability and Accountability Act (HIPAA) that specifies physical safeguards that are required 
for protection of Electronic Protected Health Information (EPHI) to avoid unauthorized disclosure, 
modification, or destruction. The CNDA system has the functionality to create audit tables used to 
monitor traffic through the system and to identify unauthorized attempts to upload or change 
information or otherwise cause damage. 
14 
PROTECTIONS, RIGHTS, AND CONFIDENTIALITY 
14.1 
Informed Consent 
The informed consent process will occur in accordance with the Declaration of Helsinki, ICH 
GCP, U.S. Code of Federal Regulations for Protection of Human Subjects (21 CFR 50.25[a,b], 
CFR 50.27, and CFR Part 56, Subpart A), the Health Insurance Portability and Accountability Act 
(HIPAA), and applicable institutional research policies and procedures. 
Written informed consent will be obtained from each research participant prior to the initiation of 
any research procedure. All participants will be given ample opportunity to review the informed 
consent form to consider participation in the study, under circumstances that would eliminate 
undue influence, and time to discuss with family and the research team. Participants will be 
informed of the right to refuse to participate that will not involve a penalty or loss of benefits. A 
participant may withdraw from study participation at any time without interfering with routine 
clinical care.  The informed consent process will take place in a private area. The Investigator or 
designee will review the consent form with the participant, confirm eligibility criteria and assess 
the participants’ level of understanding. The informed consent process shall be documented, and 
a copy of the consent will be provided to the participant. 
14.2 
Confidentiality 
See the Data Archiving section for details. All data are safeguarded in accordance with the Health 
Insurance Portability and Accountability Act (HIPAA) and by the principles and practices of strict 
confidentiality. Protected Health Information (PHI) on study participants will be managed 
according to Washington University Policies and Security Requirements. Studies are done for 
research purposes only. Reports from patients’ records concerning research observations will not 
be available to outside medical facilities without written consent of the participant. Participants 
will be given the contact information for the University’s Privacy Officer for questions or concerns 
about privacy and the use of PHI. 
Electronic data obtained as part of the research project will be stored on a secure network with 
password access.  Hardcopy data will be stored in a 2-tiered locked system. The research team will 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 43 of 49 
follow state and federal laws. The research team will obtain consent to use and share the subject’s 
information. When possible, the research team will de-identify information that could be linked to 
the subject. 
Participant study related electronic data may be saved to Box, a HIPAA compliant cloud-based 
file storage and collaboration tool that allows for file sharing. Any electronic data saved to local 
computers are encrypted, password-protected with limited access. Participant hardcopy data (e.g., 
participant signed consent forms) will be stored under a 2-tiered locked system with limited access 
to only research team members. 
14.2.1 Certificate of Confidentiality  
To further protect the privacy of study participants, a Certificate of Confidentiality (CoC) will be 
issued by the National Institutes of Health (NIH). This certificate protects identifiable research 
information from forced disclosure of research participants. It allows the investigator and study 
team members or others who have access to research records to refuse to disclose identifying 
information on research participants in any civil, criminal, administrative, legislative, or other 
proceedings, regardless of the type of whether at the federal, state, or local level. 
14.3 
Data Protection 
Participants will be assigned a unique research ID code for the research study. Imaging scans and 
the data and study documents produced as a result of the research and used for evaluation or 
statistical analysis are labeled with the ID code and the date of the scan.  
Publications emanating from this research will not identify individual participants. Reports from 
patients’ records concerning research observations will not be available to outside medical 
facilities without the written consent of the participant.  
14.4 
Data Security  
Informed consent will be obtained to use and share information. When possible, the research team 
will de-identify information that could be linked to the participant. Signed hard copy consent forms 
will be stored in a 2-tiered locked system with limited access to research team members. 
14.5 
Future Use of Data/ Data Sharing 
Important elements for data sharing are included in the consent form and are discussed during the 
informed consent process. All data is coded and linked with the subject’s unique identifier. 
Information generated by this study, including data and stored blood samples, if applicable will be  
to be used now and in the future to address research questions in similar fields or other unrelated 
areas. Research investigators may be at Washington University or outside the university at other 
research centers, institutions, or industry sponsor of the research.  


Drug: [68Ga]Galmydar 
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Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
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Version 4.1, 2022-12-06 
 
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Coded study data will be maintained at Washington University. This coded data may also be shared 
with other investigators doing research in similar fields. These investigators may be at Washington 
University or other research institutions. We may also share coded data with large repositories for 
broad sharing with the research community. If the participant’s research data is placed in one of 
these repositories, only qualified researchers who have received prior approval from individuals 
that monitor the use of the data will be able to look at this information.  
15 
ETHICAL AND FINANCIAL CONSIDERATIONS 
15.1 
Washington University Institutional Review Board 
This imaging study will be conducted in compliance with the protocol approved by Washington 
University Institutional Review Board, the Human Research Protection Office (HRPO) and in 
accordance with state and federal government regulations standards of Good Clinical Practice, and 
applicable institutional research policies and procedures. 
The Sponsor-Investigator/ Principal Investigator agrees the study will not be initiated prior FDA 
correspondence to proceed and not before receipt of IRB or other required regulatory committee 
approvals. The protocol and informed consent form will be reviewed and approved by IRB/HRPO 
and the Radioactive Research Drug Committee (RDRC) at Washington University. All subsequent 
amendments will be submitted to IRB/HRPO and if applicable, the RDRC for approval and other 
applicable committees as needed. 
Washington University complies with the regulations outlined in 45 CFR 46, 21 CFR 50, and 21 
CFR 56. The Association for the Accreditation of Human Research Protection Programs has 
accredited the Institutional Human Research Protection Program since 2004. WU HRPO has two 
duly appointed IRBs established and is registered in accordance with 45 CFR 46.107, 21 CFR 
56.106, and 21 CFR 56.107. 
15.2 
Funding Source 
The U.S. National Institutes of Health is funding this imaging study.  
15.3 
Conflict of Interest 
The Sponsor-Investigator, Principal Investigator, and Sub-Investigators of the research team will 
follow applicable University Conflict of Interest policies statements as required under Part 54 of 
Title 21 of the CFR. All members of the research team will verify their financial interests related 
to the study. The Sponsor-Investigator will promptly report any changes to financial disclosure 
information according to institutional policies and FDA guidelines for financial interest under 21 
CFR 312.57b and 312.64. 


Drug: [68Ga]Galmydar 
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 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
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15.4 
Participant Compensation  
Research participants are compensated for their time, research‐related inconveniences and 
discomforts experienced during the study. Any expenses incurred in reimbursing participants are 
for reasonable and customary medical costs incurred related to the treatment of an adverse event 
experienced that is determined, in consultation with the Sponsor-Investigator/Principal 
Investigator, was reasonably related to the administration of the investigational radiotracer, 
68Ga-Galmydar. 
16 
ATTACHMENTS  
The Schedule of Activities (SoA) tables for each group begins on the next page, see Table 2 for 
the Dosimetry group and the Table 3 for the Rest/Stress group. 
  
 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 46 of 49 
Table 2. Schedule of Activities–Dosimetry Group 
 
 
 
Whole-Body PET Imaging  
 
Procedure 
Pre-
Screen(a) 
Screening 
Visit(b,c) 
[68Ga]Galmydar 
PET/CT(i) 
Delayed     
Imaging(i) 
Discharge(i) 
Phone  
Follow-
up(j) 
Written Informed Consent(b) 
 
X 
 
 
 
 
Inclusion/Exclusion Criteria(b) 
X 
X 
 
 
 
 
Adverse Events Monitoring(b) 
 
X 
X 
X 
X 
X 
Medical Records (EHR)(c)  
X 
X 
X 
X 
X 
X 
Demographics(b) 
X 
X 
 
 
 
 
Medical History(b) 
X 
X 
 
 
 
 
Concomitant Medication(b) 
X 
X 
 
 
 
X 
Physical Exam/Evaluation(b) 
 
X 
 
 
X 
 
Body Weight and Height(b) 
 
X 
 
 
 
 
IV line placement(d)  
 
X 
 
 
 
 
Clinical safety labs(e) 
 
X 
X 
 
X 
 
Vital Signs(f,h,i) 
 
X 
X 
X 
X 
 
12-lead Electrocardiogram(h,j) 
 
X 
X 
 
X 
 
Safety Monitoring(j) 
 
 
X 
X 
 
 
Whole-Body PET/CT imaging(i,k) 
 
 
X 
X 
 
 
a) A phone call will be conducted to determine participant interest, eligibility, and schedule study visits.  
b) Screening will occur in the CCIR facility.  
c) Safety monitoring for adverse events (AE) will occur from the time of injection to the end of 
participation. Participants’ medical records (EHR) are followed in the event of an adverse 
event.                                                                                                                                                                                   
A physician or designee must evaluate participants at baseline or [68Ga]Galmydar pre-injection and 
post-imaging before discharge. 
d) Two peripheral IV catheters will be placed for the [68Ga]Galmydar injection and collection of blood 
samples.  
e) Blood and urine samples will be obtained for clinical safety labs (complete blood count, 
comprehensive metabolic panel, and urinalysis) at screening and post imaging prior to discharge. For 
women of child-bearing potential, a urine pregnancy test must be obtained and confirmed as 
negative. See Safety Assessments section. 
f) Vital signs will be obtained at screening, baseline within 5 to 15-min pre-injection and within 5 to 
15-min -min post injection, end of first imaging session, beginning of each delayed imaging session, 
and prior to discharge from the imaging facility. Repeat as needed.  
g) A 12-lead ECG will be performed at screening, baseline within 60-min prior to injection, within 5 to 
15-min post-injection, end of first imaging session, and prior to discharge from imaging facility. 
Repeat as needed.  
h) Monitoring during the PET study:  Place a blood pressure cuff on the opposite arm used for the 
radiotracer administration to measure blood pressure and heart rate. Place electrodes on the 
participant’s chest for continuous ECG monitoring and electrodes to obtain 12-lead ECG. 
i) Obtain a low-dose CT-AC (50 mAs) prior to the 8 mCi ±20% (6.4‒9.6 mCi) IV injection of 
[68Ga]Galmydar followed by a 10 mL saline flush. Begin whole-body PET image acquisition from 
the head to mid-thigh immediately post [68Ga]Galmydar injection for 30-min and repeat at 2 hours 
and 4 hours.  
j) 
Phone follow-up will occur within 2-3 days and repeated at 5-7 days or as late as 14-days post 
[68Ga]Galmydar injection. If any of the days are not business days, the follow-up phone call may 
occur the following business day.   
 
 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 47 of 49 
Table 3. Schedule of Activities–Rest/Stress Group 
Procedure 
Pre- 
Screen(a) 
Screening 
Visit(b) 
IMAGING DAY-1 
[68Ga]Galmydar      
PET/CT(k) 
IMAGING DAY-2 
13N-Ammonia 
     PET/CT(l) 
Phone 
 Follow-
up(o) 
Rest  Stress Discharge(m) Rest  Stress Discharge(m) 
Written Informed Consent 
 
X 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
X 
 
 
 
 
 
 
 
Adverse Events(b) 
 
X 
X 
X 
X 
X 
X 
X 
X 
Medical Records (EHR)(c)  
X 
X 
X 
X 
X 
X 
X 
X 
X 
Demographics 
X 
X 
 
 
X 
 
 
 
 
Medical History(a,d) 
X 
X 
 
 
 
 
 
 
 
Concomitant Medication(b) 
X 
X 
X 
X 
 
X 
X 
 
X 
Physical Exam/Evaluation(d) 
 
X 
 
 
 
 
 
X 
 
Body Weight and Height(b) 
 
X 
 
 
X 
 
 
 
 
IV placement(e)  
 
 
X 
 
 
X 
 
 
 
Clinical safety labs(f) 
 
X 
X 
X 
 
 
 
X 
 
Vital Signs(g) 
 
X 
X 
X 
X 
X 
X 
X 
 
12-lead Electrocardiogram(h,i)  
X 
X 
 
X 
X 
 
X 
 
Safety Monitoring(g,h,i) 
 
 
X 
X 
X 
X 
X 
X 
 
PET/CT imaging(j,k,l,m) 
 
 
X 
X 
 
X 
X 
 
 
a) A phone call will be conducted to determine participant interest, eligibility, and schedule study visits.  
b) Participants will be admitted to the Clinical and Translational Research Unit (CTRU) facility for 
screening, during the break between rest and stress [68Ga]Galmydar PET, and post-imaging safety 
assessments before discharge.  
c) Safety monitoring for adverse events (AE) will occur from the time of injection to the end of 
participation. Participants’ medical records are followed in the case of an adverse 
event.                                                                                                                                                                                   
d) A physician or designee must evaluate participants at baseline or[68Ga]Galmydar pre-injection and 
post-imaging before discharge. 
e) Two peripheral IV lines will be placed for the radiotracer injections, collection of blood samples and 
for the regadenoson administration during the stress PET imaging.   
f) Confirm fasting (≥ 6 hrs). Collect blood and urine samples for [68Ga]Galmydar safety labs (complete 
blood count, comprehensive metabolic panel, and urinalysis) at screening, baseline, and post imaging 
prior to discharge from the imaging facility. For all women of childbearing potential, a urine 
pregnancy test must be obtained and confirmed as negative. See Safety Assessments section. 
g) Obtain vital signs at screening, baseline rest [68Ga]Galmydar scan within 5 to15-min pre-injection and 
within 5 to 15-min post injection, end of rest imaging, and prior to participant transfer to the CTRU or 
discharge from the imaging facility. Repeat as needed. Follow standard-of-care clinical protocol for 
regadenoson stress imaging scans for both radiotracers, [68Ga]Galmydar and 13N-ammonia. 
h) A 12-lead ECG will be performed at screening/baseline, within 60-min prior to injection, within 5 to 
15-min pre-injection, and within 5 to 15-min post injection and end of imaging prior to discharge 
from imaging facility. For both radiotracer stress regadenoson imaging, follow the standard-of-care 
clinical protocol.  
i) Monitoring: Place a blood pressure cuff on the opposite arm used for the radiotracer administration 
to measure blood pressure and heart rate. Place electrodes on the participant’s chest for continuous 
ECG monitoring and electrodes to obtain 12-lead ECG.  
j) PET/CT imaging: Obtain a low-dose CT-AC (50 mAs) prior to each rest and stress radiotracer 
injection. If the same IV line is used for both the regadenoson and radiotracer injections, wait 
10-20 sec after the normal saline flush post regadenoson injection before injecting the radiotracer. 
 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 48 of 49 
 
 
k) [68Ga]Galmydar Imaging Day-1:  
• Rest PET: Administer 4 mCi ±20% (3.2‒4.8 mCi) of [68Ga]Galmydar IV injection followed by 
a 10 mL saline flush and immediately begin up to a 30-min list-mode data acquisition for a 
single bed position at the level of the heart. The interval between the rest and stress 
[68Ga]Galmydar PET acquisitions should be no less than 2 hours and no greater than 4 hours.  
• Stress PET MPI: Administer a rapid (10-sec) regadenoson IV injection (0.4 mg/5 mL), followed 
by 5 mL saline flush; 30-sec post regadenoson injection, administer 8 mCi ±20% (6.4‒9.6 mCi) 
of [68Ga]Galmydar IV injection followed by a 10 mL saline flush. Begin up to a 30-min list-
mode data acquisition for a single bed position at the level of the heart.  
l) 13N-Ammonia Imaging Day-2:  
• Rest PET: Administer an IV bolus injection of 10 mCi ±20% (8‒12 mCi) of 13N-Ammonia 
followed by a 10 mL saline flush and immediately begin a 10-min list-mode data acquisition (if 
the anterior-posterior diameter of the chest is >50cm increase to 15-min) for a single bed position 
at the level of the heart. The interval between the rest and stress 13N-ammonia acquisitions should 
be no less than 1-hour. 
• Stress PET MPI: Administer a rapid (10-sec) regadenoson IV injection (0.4 mg/5 mL), followed 
by 5 mL saline flush; 30-sec post regadenoson injection, administer 10 mCi ±20% (8‒12 mCi) 
of 13N-Ammonia IV bolus injection followed by a 10 mL saline flush. Begin a 10-min list-mode 
data acquisition (if the anterior-posterior diameter of the chest is >50cm increase to 15-min) for 
a single bed position at the level of the heart.  
m) Transfer [68Ga]Galmydar participants to CTRU for post imaging safety assessments and discharge. 
Discharge 13N-Ammonia participants from the CCIR. 
n) Contact [68Ga]Galmydar participants by phone within 2-3 days post [68Ga]Galmydar injection. 
[68Ga]Galmydar and 13N-ammonia imaging visits will be separated by a minimum of 3-days and not 
before the follow-up phone call is complete for capturing participant adverse events following the 
administration of [68Ga]Galmydar. If any of the days are not business days, the phone call may occur 
the following business day. 
 
 


Drug: [68Ga]Galmydar 
Serial Number 0000 
Sponsor-Investigator: Vijay Sharma, Ph.D.  
 Exploratory Investigational New Drug Application 
Galmydar Protocol 
Version 4.1, 2022-12-06 
 
Page 49 of 49 
17 
REFERENCES 
1) Sharma, V. et al. Novel gallium (III) complexes transported by MDR1 P-glycoprotein: 
potential PET imaging agents for probing P-glycoprotein-mediated transport activity in 
vivo. Chem & Biol 7, 335-343 (2000). 
2) Sharma, V. Radiopharmaceuticals for assessment of multidrug resistance P-glycoprotein-
mediated transport activity. Bioconjug .Chem. 15, 1464-1474 (2004). 
3) Sharma, V., Prior, J., Belinsky, M., Kruh, G. & Piwnica-Worms, D. Characterization of 
67Ga/68Ga-radiopharmaceutical for SPECT and PET of MDR1 P-glycoprotein transport 
activity in vivo: validation in multidrug-resistant tumors and at the blood-brain barrier. J. 
Nucl. Med. 46, 354-364 (2005). 
4) Sharma, V. et al. A Generator-Produced Gallium-68 Radiopharmaceutical for PET 
Imaging of Myocardial Perfusion. PloS one 9, e109361, doi:10.1371/journal.pone.0109361 
(2014). 
5) Sivapackiam, J., Harpstrite, S. E., Prior, J. L., Mattingly, S. & Sharma, V. 
(67/68)Galmydar: A metalloprobe for monitoring breast cancer resistance protein (BCRP)-
mediated 
functional 
transport 
activity. 
Nucl. 
Med. 
Biol. 
43, 
191-197, 
doi:10.1016/j.nucmedbio.2015.12.001 (2016). 
6) Sivapackiam J, Sharma M, Schindler TH, Sharma V. PET Radiopharmaceuticals for 
Imaging Chemotherapy-Induced Cardiotoxicity. Curr Cardiol Rep, 19;22(8):62. doi: 
10.1007/s11886-020-01315-z. (2020). 
7) Sivapackiam J., Laforest R., Sharma V. 68Ga-Galmydar: Preliminary Assessment of its 
Imaging Potential for Monitoring Acute Myocardial Infarction in Rabbits, J Nuc Medicine, 
(2017), 58 (Supplement 1): 797. 
8) Sivapackiam J., Laforest R., Sharma V. 68Ga-Galmydar: PET Imaging of Myocardial 
Infarction in Rabbits and Comparative Blood Flow Analysis in Rats, J Nuc Medicine, 
(2020), 61 (Supplement 1): 3126. 
9) Sivapackiam, J., Laforest, R. & Sharma, V. 68Ga-Galmydar: Biodistribution and Radiation 
Dosimetry Studies in Rodents Nucl Med Biol, 59, 29–35 (2018).  
 
 

ICF_001.pdf: 
 
FOR IRB USE ONLY 
IRB ID #: 202107042 
APPROVAL DATE: 08/25/22 
RELEASED DATE: 08/29/22 
EXPIRATION DATE: 08/24/23 
 
Galmydar_V1.4_26Jan2022 
 
Page 1 of 12 
INFORMED CONSENT DOCUMENT 
 
Project Title: Development and Translation of Generator-Produced PET Tracer for Myocardial 
Perfusion Imaging (Dosimetry Group) 
 
Principal Investigator: 
Pamela Woodard, MD 
 
Research Team Contact: 
Dakkota Thies at (314) 747-3839 
Kitty Harrison, RN at (314) 747-0183  
 
Molly Mohrman, RRT at (314) 747-4633 
 
This consent form describes the research study and helps you decide if you want to participate.  It 
provides important information about what you will be asked to do during the study, about the risks and 
benefits of the study, and about your rights and responsibilities as a research participant. By signing this 
form you are agreeing to participate in this study. 
• You should read and understand the information in this document including the procedures, 
risks and potential benefits.  
• If you have questions about anything in this form, you should ask the research team for more 
information before you agree to participate.   
• You may also wish to talk to your family or friends about your participation in this study. 
• Do not agree to participate in this study unless the research team has answered your 
questions and you decide that you want to be part of this study.  
 
KEY INFORMATION 
    
This is a research study conducted by Pamela Woodard, MD having to do with testing the safety of a 
new radioactive drug called 68Ga-Galmydar in healthy individuals. You should carefully consider the 
information in this consent document and discuss it with the research team. Be sure you understand 
why you might want to participate, or why you might not want to participate. You may choose to 
participate or not. 
 
If you agree and sign this consent, you will be volunteering to participate in the research study. All of 
the information below will be explained and is listed in more detail in the consent document below. The 
research team must give you a copy of this signed consent document. 
 
HOW WILL THIS STUDY AFFECT ME? 
 
• The purpose of this study is to evaluate a new radioactive drug called 68Ga-Galmydar in 
healthy individuals, to test the safety and determine the distribution of the tracer in the body 
during PET imaging at three different imaging time sessions, immediately after injection, and 
repeated at 2-hours and 4-hours later. 68Ga-Galmydar is investigational.  This means that it has 
not been approved by the U.S. Food and Drug Administration (FDA). 
• You were selected because you are a healthy adult over 18 years of age without cardiovascular 
risk factors or cardiovascular disease.  


 
FOR IRB USE ONLY 
IRB ID #: 202107042 
APPROVAL DATE: 08/25/22 
RELEASED DATE: 08/29/22 
EXPIRATION DATE: 08/24/23 
 
Galmydar_V1.4_26Jan2022  
 
Page 2 of 12 
• You will be in this study for up to 14 days depending on the completion of your follow-up phone 
call after your imaging visit. 
o As a voluntary participant, you will be asked to spend up to about 8 hours during a visit 
for screening followed by the whole-body Galmydar PET imaging.  This will all be done 
on the same day.  
• You will need to come to in the Center for Clinical Imaging Research (CCIR), a Washington 
University facility located on the 10th floor of Barnes-Jewish Hospital.  
• The main risks to you that some participants may experience are stiffness from lying still in the 
PET/CT scanner and discomfort from venous placement. More detail regarding risks are 
provided below. 
• You will be paid for participating in the study. You will not receive any charges for participating 
in this study. You will receive $400.00 for the Galmydar PET imaging scan. If your study visits 
are prematurely canceled, for example, because of technical difficulties with the imaging scanner 
or radiotracer failure and must be rescheduled for an additional study visit, you will be 
reimbursed an additional $100. If you withdraw early from the study, you will be reimbursed for 
the portion of the study you completed. If you withdraw early from the study, the research team 
may continue to use information already collected about you in this study.  
• This study is sponsored by the National Institutes of Health. 
 
WHAT IS THE PURPOSE OF THIS STUDY? 
 
This is a research study. We invite you to participate in this research study because you are a healthy 
adult over 18 years of age without cardiovascular risk factors.  
 
The purpose of this research study is to assess the role of 68Ga-Galmydar Positron Emission 
Tomography/Computed Tomography (PET/CT) imaging in human subjects to improve the likelihood of 
understanding of the atherosclerotic disease of the heart muscle.   This radiotracer may work better to image 
heart muscle (not heart vessels) because it looks at how well mitochondria (the “energy” center) inside the cell are 
working. This may help to prevent development of heart disease, heart attacks or even sudden cardiac 
death in individuals with cardiovascular risk.  
 
68Ga-Galmydar, a radioactive tracer, is considered investigational, which means that it has not been 
approved by the U.S. Food and Drug Administration.   
 
WHAT WILL HAPPEN DURING THIS STUDY? 
 
You will be asked to come to the Center for Clinical Imaging Research (CCIR) facility, a Washington 
University facility, located on the 10th floor of Barnes-Jewish Hospital for your PET study for your 
screening and whole-body 68Ga-Galmydar PET imaging scan. The screening visit will be done on the 
same day as your imaging visit. 
 
The screening visit will begin in a private consultation room where the Study Coordinator will review 
the consent with you and go over what will happen during the study. You will have the opportunity to 
review the consent in private and to ask further questions before signing the consent form. 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 202107042 
APPROVAL DATE: 08/25/22 
RELEASED DATE: 08/29/22 
EXPIRATION DATE: 08/24/23 
 
Galmydar_V1.4_26Jan2022  
 
Page 3 of 12 
For your safety, we will ask questions about your medical history, prior surgical procedures, current 
medications, and family history. If you are a woman of child-bearing potential, a urine pregnancy test 
will be conducted. Women who are pregnant or breast-feeding will not be eligible to participate in the 
study. Women must avoid becoming pregnant and must agree to refrain from sexual activity or to use 
reliable contraceptive methods for 24 hours following administration of 68Ga-Galmydar. We will also 
obtain a blood sample, ECG, height, weight, and vital signs.  
 
HOW SHOULD I PREPARE FOR MY VISIT? 
 
Prior to the Screening and PET/CT Visit: 
• Leave your jewelry at home, if possible. 
• Bring an updated medication list. 
• Eat only a light meal 6-hours prior to your imaging visit.  
 
On the day of your Screening and PET/CT Visit: 
 
Screening 
• If you are a woman of child-bearing potential, a urine pregnancy test must be completed and 
confirmed as negative prior to the PET scan. 
• You can stow your personal possessions in a secure locker in the CCIR imaging facility.   
• Vital sign measurements (blood pressure, breathing rate, heart rate, and body temperature) will 
be obtained screening, baseline within 5 to 15-min pre-injection and within 5 to 15-min -min 
post injection, end of first imaging session, beginning of each imaging session, and prior to 
discharge from the imaging facility. 
• Before imaging 12-lead Electrocardiogram (ECG) lead wires will be placed on your chest to 
monitor your heart rhythm. A 12-lead ECG will be performed at screening, baseline within 60-
min prior to injection, within 5 to 15-min post-injection, end of first imaging session, and prior to 
discharge from imaging facility. A total of 5 ECGs will be performed. 
• You will have two catheters (IV) placed in your veins of your arms, one on the right and a 
second on the left. One IV will be used to inject the 68Ga-Galmydar tracer and the second IV 
will be used to obtain blood samples.  
• Safety lab testing: Blood samples will be drawn for safety testing prior to the injection of 68Ga-
Galmydar, shortly after the injection, and again after your PET scan is completed 
(approximately 2 tablespoons). You will be asked to provide a urine sample before and after the 
PET scan. We will compare the before and after test results to see whether or not the 68Ga-
Galmydar tracer made any changes your safety labs. 
• Screening will take up to about 2 hours. 
 
PET/CT Imaging 
• This study will use a combined PET/CT scanner to take pictures of your body. PET scanners 
allow us to image the radiotracer uptake throughout your body after you are injected with a 
radiotracer. The CT scan (Computed Tomography) is a type of x-ray scanner that images of your 
body. The combined PET/CT scanner is a special type of scanner that allows us to perform 
whole body imaging, from the top of your head to your mid-thigh following the injection of a 
radiotracer. 


 
FOR IRB USE ONLY 
IRB ID #: 202107042 
APPROVAL DATE: 08/25/22 
RELEASED DATE: 08/29/22 
EXPIRATION DATE: 08/24/23 
 
Galmydar_V1.4_26Jan2022  
 
Page 4 of 12 
• PET imaging will occur in three different imaging time sessions, immediately after injection for 
about one hour, and repeated at 2-hours and 4-hours later. You will be removed from the scanner 
for a break between imaging sessions. 
• For your safety, your electrocardiogram (heart rhythm) and blood pressure will be monitored 
throughout the PET/CT exam. Research staff will be available at all times in the scanner room or 
in the console room. A room next to the scanner room during your imaging scan. 
• PET imaging will take up to about 6 hours.  
 
After the PET/CT Visit:  
• Research staff will call you within 2-3 business days of your Galmydar PET/CT imaging scan to 
ask if you have any changes in your health since the scan, which should take approximately 5-10 
minutes. If both days are not business days, the follow-up phone call can occur the following 
business day.  
• You will have a second telephone follow-up phone call 5-7 days and as late as 14 days for 
monitoring of adverse events. Additional telephone calls may be conducted as necessary.  
 
• The PET/CT images you will have for this study are for specific research purposes and are not 
being used to evaluate your health or find medical abnormalities. These images will not be 
reviewed by a radiology physician to diagnose existing abnormalities. 
 
Will you save my research information to use in future research studies? 
 
We would like to use the data we are obtaining in this study for studies going on right now as well as 
studies that are conducted in the future. These studies may provide additional information that will be 
helpful in understanding disease, or other diseases or conditions, including research to develop 
investigational tests, treatments, drugs or devices that are not yet approved by the U.S. Food and Drug 
Administration. It is unlikely that what we learn from these studies will have a direct benefit to you.  
There are no plans to provide financial compensation to you should this occur. By allowing us to use 
your data you give up any property rights you may have in the data. 
 
We will share your data with other researchers. They may be doing research in areas similar to this 
research or in other unrelated areas. These researchers may be at Washington University, at other 
research centers and institutions, or industry sponsors of research. We may also share your research data 
with large data repositories (a repository is a database of information) for broad sharing with the 
research community. If your individual research data is placed in one of these repositories only qualified 
researchers, who have received prior approval from individuals that monitor the use of the data, will be 
able to look at your information.   
 
If you change your mind and do not want us to store and use your data for future research you should 
contact the research team member identified at the top of this document. The data will no longer be used 
for research purposes. However, if some research with your data has already been completed, the 
information from that research may still be used. Also, if the data has been shared with other researchers 
it might not be possible to withdraw the data to the extent it has been shared. 
 


 
FOR IRB USE ONLY 
IRB ID #: 202107042 
APPROVAL DATE: 08/25/22 
RELEASED DATE: 08/29/22 
EXPIRATION DATE: 08/24/23 
 
Galmydar_V1.4_26Jan2022  
 
Page 5 of 12 
HOW MANY PEOPLE WILL PARTICIPATE? 
 
We plan to enroll 38 people in this study conducted at Washington University. About 8 people will take 
part in the dosimetry group. 
 
HOW LONG WILL I BE IN THIS STUDY? 
 
If you agree to take part in this study, your involvement will last for up to 14 days. 
 
WHAT ARE THE RISKS OF THIS STUDY? 
 
You may experience one or more of the risks stated below from being in this study. Besides these, there 
may be other unknown risks, or risks that we did not expect, associated with being in this study.  
 
Some risks described in this consent document, if severe, may cause death.  
 
Risks associated with 68Ga-Galmydar Radiotracer: 
 
Less Likely: There are no known adverse reactions to 68Ga-Galmydar.  68Ga-Galmydar will be given 
in minimal amounts. Based on common responses to other tracers, we expect some 
participants may experience dysgeusia (bad taste in mouth), flushing, headache, dizziness 
or lightheadedness, mild gastroenteritis, pruritus, urticaria. 
Rare: 
There is a possibility of a severe allergic reaction. Such a reaction could be serious and 
even cause death. Symptoms include low blood pressure, difficulty breathing, swelling of 
your tongue, mouth and or throat, body itching or rashes. If you experience any of these 
or any other symptoms, please notify the study team right away. 
 
Risks associated with PET/CT Imaging Scanner 
 
Likely: 
You may experience aching in your joints and muscles from lying still. Study staff will 
be nearby to stop the study in case you become uncomfortable. We will try to 
minimize any discomfort. 
Less Likely: 
Some participants experience claustrophobia (anxiety because of being confined to a 
small space) and may experience dizziness or feel faint. The scanner will be stopped 
immediately if you experience these symptoms and do not wish to continue the study. 
Laying on the PET scanner table for a prolonged time may worsen this condition if you 
have pre-existing back, joint or muscle problems. 
 
Rare:   
Malfunction of worn or implanted electronic medical devices. 
 
If you have electronic medical devices implanted such as a pacemaker or a drug pump, please make sure 
you tell your study doctors and research staff.  The CT scan may cause a malfunction of electronic 
medical devices. 
 


 
FOR IRB USE ONLY 
IRB ID #: 202107042 
APPROVAL DATE: 08/25/22 
RELEASED DATE: 08/29/22 
EXPIRATION DATE: 08/24/23 
 
Galmydar_V1.4_26Jan2022  
 
Page 6 of 12 
Risks associated with Radiation Exposure  
 
The risk associated with the amount of radiation exposure participants receive during the research study 
is low and comparable to other everyday risks.  
 
68Ga-Galmydar Whole-Body PET Imaging 
 
Likely:  
This study will expose you to radiation from the administration of 68Ga-Galmydar 
(galmydar labeled with gallium-68 radioactivity) and the low-dose whole-body 
computerized tomography (CT) scan performed during the PET scan. The maximum 
amount of radiation from a single administration of 68Ga-Galmydar and three whole-body 
CT scans, when averaged over the entire body, is about 57% of the amount that a person 
who works with radiation is allowed to have in one year. It is not a big risk when 
compared with other risks you take every day. If you want to know more about radiation 
exposure, please see the “Radiation Fact sheet” at http://hrpo.wustl.edu or ask the study 
staff for a copy.    
 
Risks associated with IV insertion and blood drawing 
 
Likely: 
The placement of an IV (small plastic catheter tube) in your arm may be associated with a 
small amount of discomfort and bleeding. 
Less likely: 
Bruising and/or bleeding at the site of the initial IV catheter placement. Occasionally 
some people experience dizziness or feel faint. 
Rare: 
Infection at the site of the initial IV catheter placement.  
 
Risks of Electrocardiogram 
 
Likely: 
 
You may feel discomfort from the placement and removal of the electrode patches (small 
patches with sticky adhesive on one side that allows the patch to stick to your skin).  
Remaining still while the ECG is taken (less than 1 minute) may cause anxiety.  
 
Women Capable of Becoming Pregnant 
 
If you are a woman capable of becoming pregnant, we will ask you to have a pregnancy test before 
beginning this study. You must use effective birth control methods and try not to become pregnant while 
participating in this study. If you become pregnant, there may be unknown risks to your unborn child, or 
risks to your unborn child that we did not anticipate. There may be long-term effects of the treatment 
being studied that could increase the risk of harm to an unborn child. You must tell the doctor if your 
birth control method fails while you are on the study. If you believe or know you have become pregnant 
while participating in this research study, please contact the research team member identified at the top 
of this document as soon as possible. Please discuss with the research team how long you need to wait 
before becoming pregnant after completing the treatment or procedures on this study. 
 
 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 202107042 
APPROVAL DATE: 08/25/22 
RELEASED DATE: 08/29/22 
EXPIRATION DATE: 08/24/23 
 
Galmydar_V1.4_26Jan2022  
 
Page 7 of 12 
Radiation Exposure in Women Capable of Becoming Pregnant 
 
You may not participate in this study if you are pregnant.  If you are capable of becoming pregnant, we 
will perform a pregnancy test before exposing you to research-related radiation.  You must tell us if you 
may have become pregnant within the previous 14 days because the pregnancy test is unreliable during 
that time. 
 
Breach of Confidentiality 
 
One risk of participating in this study is that confidential information about you may be accidentally 
disclosed.  We will use our best efforts to keep the information about you secure.  Please see the section 
in this consent form titled “How will you keep my information confidential?” for more information. 
 
WHAT ARE THE BENEFITS OF THIS STUDY? 
 
You will not benefit from being in this study. However, we hope that, in the future, other people might 
benefit from this study because information from this research may improve the understanding of the 
atherosclerotic disease of the heart vessels, which may help to prevent development of heart disease, 
heart attacks or even sudden cardiac death in individuals with cardiovascular risk. 
 
WILL IT COST ME ANYTHING TO BE IN THIS STUDY? 
 
You will not have any additional costs for being in this research study. 
             
You and/or your medical/hospital insurance provider will remain responsible for your regular medical 
care expenses. 
 
WILL I BE PAID FOR PARTICIPATING? 
 
You will be paid for being in this research study. You will need to provide your social security number 
(SSN) in order for us to pay you. You may choose to participate without being paid if you do not wish to 
provide your social security number (SSN) for this purpose.  You may also need to provide your address 
if a check will be mailed to you. Your check will be mailed to you approximately 3 weeks after your 
research visit. If your social security number is obtained for payment purposes only, it will not be 
retained for research purposes.    
 
• $400 for the screening and whole body Galmydar PET/CT visit 
• If your study visits are prematurely canceled, for example, due to technical difficulties with the 
imaging scanner or radiotracer failure and must be rescheduled for an additional study visit, you 
will be reimbursed an additional $100. 
• If you complete only part of a study your reimbursement will be prorated proportionately. 
 
WHO IS FUNDING THIS STUDY? 
 
National Institute of Health (NIH) is funding this research study.  This means that Washington 
University is receiving payments from NIH to support the activities that are required to conduct the 


 
FOR IRB USE ONLY 
IRB ID #: 202107042 
APPROVAL DATE: 08/25/22 
RELEASED DATE: 08/29/22 
EXPIRATION DATE: 08/24/23 
 
Galmydar_V1.4_26Jan2022  
 
Page 8 of 12 
study.  No one on the research team will receive a direct payment or increase in salary from NIH for 
conducting this study. 
 
WHAT IF I AM INJURED AS A RESULT OF THIS STUDY? 
 
Washington University investigators and staff will try to reduce, control, and treat any complications 
from this research. If you feel you are injured because of the study, please contact the investigator at Dr. 
Pamela Woodard at (314) 747-3878 or (314) 362-3386 and/or the Human Research Protection Office at 
1-(800)-438-0445.  
 
Decisions about whether payment for medical treatment for injuries relating to your participation in 
research will be made by Washington University. If you need to seek medical care for a research-related 
injury, please notify the investigator as soon as possible.  
 
 HOW WILL YOU KEEP MY INFORMATION CONFIDENTIAL? 
 
Other people such as those indicated below may become aware of your participation in this study and 
may inspect and copy records pertaining to this research.  Some of these records could contain 
information that personally identifies you.  
• Government representatives (including the Office for Human Research Protections) to complete 
federal or state responsibilities 
• The U.S. Food and Drug Administration (FDA) 
• National Institutes of Health (NIH) 
• Your primary care physician if a medical condition that needs urgent attention is discovered  
• Hospital or University representatives to complete Hospital or University responsibilities 
• Information about your participation in this study may be documented in your health care records 
and will be available to anyone with access to your health care record, including your health 
insurance company.  This information may also be released as part of a release of information 
request. 
• The last four digits of your social security number may be used in hospital or University systems 
to track billing information for research procedures. 
• Washington University’s Institutional Review Board (a committee that oversees the conduct of 
research involving human participants) and the Human Research Protection Office. The 
Institutional Review Board has reviewed and approved this study.  
• Any report or article that we write will not include information that can directly identify you.  
The journals that publish these reports or articles require that we share your information that was 
collected for this study with others to make sure the results of this study are correct and help 
develop new ideas for research. Your information will be shared in a way that cannot directly 
identify you. 
 
To help protect your confidentiality, we will make sure information cannot be linked to you (de-
identified).  This means that identifying information such as name or date of birth will not be included 
with the information and, instead, you will be referenced by a number or ‘anonymous identifier’.  
Patient information, including anonymous identifiers used to link to research data, will be kept in a 
separate encrypted and password-protected database that will be accessible only to engaged team 


 
FOR IRB USE ONLY 
IRB ID #: 202107042 
APPROVAL DATE: 08/25/22 
RELEASED DATE: 08/29/22 
EXPIRATION DATE: 08/24/23 
 
Galmydar_V1.4_26Jan2022  
 
Page 9 of 12 
members.  Any documents which include patient information, including anonymous identifiers used to 
link to research data will be kept in a locked filing cabinet in a locked office suite; that will be accessible 
only to engaged team members.  
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time.  
 
To further protect your privacy, this research is covered by a Certificate of Confidentiality from the 
federal government. This means that the researchers can refuse to disclose information that may identify 
you in any legal or court proceeding or to anyone who is not connected with the research except if:  
• there is a law that requires disclosure, such as to report child abuse and neglect, or harm to self or 
others;  
• you give permission to disclose your information, including as described in this consent form; or 
• it is used for other scientific research allowed by federal law. 
 
This Certificate may not be effective for information held in foreign countries. 
 
You have the right to share your information or involvement in this study with anyone at any time. You 
may also give the research team permission to disclose your information to a third party or any other 
person not connected with the research.  
 
Are there additional protections for my health information? 
 
Protected Health Information (PHI) is health information that identifies you. PHI is protected by federal 
law under HIPAA (the Health Insurance Portability and Accountability Act). To take part in this 
research, you must give the research team permission to use and disclose (share) your PHI for the study 
as explained in this consent form.  The research team will follow state and federal laws and may share 
your health information with the agencies and people listed under the previous section titled, “How will 
you keep my information confidential?” 
 
Once your health information is shared with someone outside of the research team, it may no longer be 
protected by HIPAA.   
 
The research team will only use and share your information as talked about in this form or as permitted 
or required by law.  When possible, the research team will make sure information cannot be linked to 
you (de-identified).  Once information is de-identified, it may be used and shared for other purposes not 
discussed in this consent form. If you have questions or concerns about your privacy and the use of your 
PHI, please contact the University’s Privacy Officer at 866-747-4975.  
 
Although you will not be allowed to see the study information, you may be given access to your health 
care records by contacting your health care provider.  
 
If you decide not to sign this form, it will not affect 
• your treatment or the care given by your health provider. 


 
FOR IRB USE ONLY 
IRB ID #: 202107042 
APPROVAL DATE: 08/25/22 
RELEASED DATE: 08/29/22 
EXPIRATION DATE: 08/24/23 
 
Galmydar_V1.4_26Jan2022  
 
Page 10 of 12 
• your insurance payment or enrollment in any health plans.   
• any benefits to which you are entitled. 
However, it will not be possible for you to take part in the study. 
 
If you sign this form: 
• You authorize the use of your PHI for this research 
• This authorization does not expire. 
• You may later change your mind and not let the research team use or share your information 
(you may revoke your authorization).  
• To revoke your authorization, complete the withdrawal letter, found in the Participant section 
of the Human Research Protection Office website at 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ or you may request that the 
investigator send you a copy of the letter.    
 
 
 
o If you revoke your authorization: 
 The research team may only use and share information already collected for 
the study. 
 Your information may still be used and shared as necessary to maintain the 
integrity of the research, for example, to account for a participant’s 
withdrawal from the research study or for safety reasons. 
 You will not be allowed to continue to participate in the study. 
 
IS BEING IN THIS STUDY VOLUNTARY? 
 
Taking part in this research study is completely voluntary.  You may choose not to take part at all.  If 
you decide to be in this study, you may stop participating at any time. Any data that was collected as 
part of your participation in the study will remain as part of the study records and cannot be removed.   
 
If you decide not to be in this study, or if you stop participating at any time, you won’t be penalized or 
lose any benefits for which you otherwise qualify.   
 
What if I decide to withdraw from the study? 
 
You may withdraw by telling the study team you are no longer interested in participating in the study or 
you may send in a withdrawal letter. A sample withdrawal letter can be found at 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ under Withdrawing from a Research 
Study. 
 
Will I receive new information about the study while participating? 
 
If we obtain any new information during this study that might affect your willingness to continue 
participating in the study, we’ll promptly provide you with that information. 
 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 202107042 
APPROVAL DATE: 08/25/22 
RELEASED DATE: 08/29/22 
EXPIRATION DATE: 08/24/23 
 
Galmydar_V1.4_26Jan2022  
 
Page 11 of 12 
Can someone else end my participation in this study? 
 
Under certain circumstances, the investigator might decide to end your participation in this research 
study earlier than planned.  This might happen for no reason or because in our judgment it would not be 
safe for you to continue.  Circumstances would include adverse reaction to administered radioactive 
tracers.  The PI will share any new information that could change how you feel about continuing in the 
study. 
WHAT IF I HAVE QUESTIONS? 
 
We encourage you to ask questions.  If you have any questions about the research study itself, please 
contact: Dr. Pamela Woodard at (314) 747-3878 or (314) 362-3386, Dakkota Thies at (314) 747-3839,  
Kitty Harrison, RN at (314) 747-0183 or Molly Mohrman at (314) 747-4633. If you experience a 
research-related injury, please contact: Dr. Pamela Woodard at (314) 747-3878 or (314) 362-3386, 
Dakkota Thies at (314) 747-3839, Kitty Harrison, RN at (314) 747-0183 or Molly Mohrman at (314) 
747-4633. 
 
If you have questions, concerns, or complaints about your rights as a research participant, please contact 
the Human Research Protection Office 1-(800)-438-0445, or email hrpo@wustl.edu.   General 
information about being a research participant can be found on the Human Research Protection Office 
web site, http://hrpo.wustl.edu.  To offer input about your experiences as a research participant or to 
speak to someone other than the research staff, call the Human Research Protection Office at the number 
above. 
 
 
This consent form is not a contract. It is a written explanation of what will happen during the study if 
you decide to participate. You are not waiving any legal rights by agreeing to participate in this study. 
As a participant you have rights and responsibilities as described in this document and including: 
• To be given enough time before signing below to weigh the risks and potential benefits and 
decide if you want to participate without any pressure from the research team or others. 
• To understand all of the information included in the document, have your questions answered, 
and receive an explanation of anything you do not understand. 
• To follow the procedures described in this document and the instructions of the research team to 
the best of your ability unless you choose to stop your participation in the research study. 
• To give the research team accurate and complete information. 
• To tell the research team promptly about any problems you have related to your participation, or 
if you are unable to continue and wish to stop participating in the research study. 
 


 
FOR IRB USE ONLY 
IRB ID #: 202107042 
APPROVAL DATE: 08/25/22 
RELEASED DATE: 08/29/22 
EXPIRATION DATE: 08/24/23 
 
Galmydar_V1.4_26Jan2022  
 
Page 12 of 12 
Your signature indicates that this research study has been explained to you, that your questions have 
been answered, and that you agree to take part in this study.  You will receive a signed and dated copy 
of this form. 
 
 
Do not sign this form if today’s date is after EXPIRATION DATE: 08/24/23. 
 
 
__________________________________________ 
_______________________________ 
(Signature of Participant) 
 
 
 
 
(Date) 
 
 
____________________________________________ 
(Participant's name – printed) 
 
 
 
 
Statement of Person Who Obtained Consent 
 
The information in this document has been discussed with the participant or, where appropriate, with the 
participant’s legally authorized representative.  The participant has indicated that they understand the 
risks, benefits, and procedures involved with participation in this research study. 
 
 
__________________________________________ 
_______________________________ 
(Signature of Person who Obtained Consent) 
 
(Date) 
 
 
___________________________________________ 
(Name of Person who Obtained Consent - printed)