A Study to Assess the Impact of Moderate/Significant Infiltrations on the Standardized Uptake Values of Target Lesions
Phase: NA
Conditions: Dose Response Relationship, Drug
Sponsor: Wake Forest University Health Sciences

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LUCERNO DYNAMICS, LLC 
 
A Study to Assess the Impact of Moderate/Significant Infiltrations on the 
Standardized Uptake Values of Target Lesions  
Protocol Number: 
LUC-2017-001 
Version: 
0 
Device: 
Lucerno Dynamics LaraTM System for  
QA/QC in Imaging 
Sponsor: 
Lucerno Dynamics, LLC 
142 Towerview Court 
Cary 
NC 27513  
Study Investigators:  
Name:  
Shane C. Masters, MD, PhD 
Telephone:    336-716-3590 
Fax:  
336-716-6108 
E-mail:           smasters@wakehealth.edu 
 
Name:  
A. William Blackstock, Jr, MD 
Telephone:    336-713-3600 
Fax:  
 
E-mail:           ablackst@wakehealth.edu 
 
 
 
 
 
Approval: 
 
 
 
Study Principal Investigator Signature (Name and 
Title)  
 
Study Co-Principal Investigator Signature (Name and 
Title) 
 
Date 
 
 
Date 

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This confidential information about a medical device product is provided for the exclusive 
use of Study PIs of this product and is subject to recall at any time.  The information in 
this document may not be disclosed unless federal or state law or regulations require 
such disclosure.  Subject to the foregoing, this information may be disclosed only to those 
persons involved in the study who have a need to know, with the obligation not to further 
disseminate this information.   
 
 
 

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PROTOCOL AGREEMENT 
 
I have read the protocol specified below. In my formal capacity as Study Principal 
Investigator, my duties include ensuring the safety of the study subjects enrolled under 
my supervision and providing Lucerno Dynamics with complete and timely information, 
as outlined in the protocol.  It is understood that all information pertaining to the study 
will be held strictly confidential and that this confidentiality requirement applies to all 
study staff at this site. Furthermore, on behalf of the study staff and myself, I agree to 
maintain the procedures required to carry out the study in accordance with accepted 
GCP principles and to abide by the terms of this protocol. 
 
Protocol Number: LUC-2017-001 
 
Protocol Title: A Study to Assess the Impact of Moderate/Significant Infiltrations on 
the Standardized Uptake Values of Target Lesions  
 
Protocol Date: December 19, 2017 
 
 
 
 
Study Principal Investigator Signature  
 
Date 
 
Print Name and Title 
 
   
 
 
 
Study Co-Principal Investigator Signature  
 
Date 
 
Print Name and Title 
 
        
   
Site # 
1 
 
Site Name 
Wake Forest Baptist Medical Center 
Address 
Medical Center Boulevard 
 
Winston-Salem, NC 27157 
 
 
 
 
 
 
 

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1.0 
INTRODUCTION AND BACKGROUND ................................................. 9 
2.0 
PURPOSE OF THE STUDY .................................................................. 10 
2.1 
Objectives of the study ....................................................................... 10 
2.1.1 Primary Objective ....................................................................................................... 10 
2.1.2 
Exploratory Objectives ........................................................................................ 11 
2.2.  Anticipated duration of the study ...................................................... 11 
3.0 
PROTOCOL .......................................................................................... 11 
3.1 
Protocol number and title ................................................................... 11 
3.2 
Protocol version number and date .................................................... 11 
3.3 
Project design ...................................................................................... 11 
3.4 
Subject selection ................................................................................. 11 
3.4.1 
Inclusion criteria .................................................................................................. 11 
3.4.2  
Exclusion criteria ................................................................................................. 11 
3.4.3 
Anticipated number of subjects ......................................................................... 12 
3.5 
Study procedure .................................................................................. 12 
3.5.1 
Withdrawal of subjects due to non-compliance ............................................... 13 
3.5.2 
Procedures to assess efficacy ........................................................................... 13 
3.5.3 
Procedures to assess safety ............................................................................... 13 
3.5.4 
Schedule of study visits ...................................................................................... 13 
3.6 
Study Objectives ................................................................................. 13 
3.6.1 
Primary Objective ................................................................................................. 13 
3.6.2 
Exploratory Objectives ........................................................................................ 13 
3.6.3 
Sample size determination .................................................................................. 13 
3.6.4 
Data Analysis ........................................................................................................ 13 
4.0 
RISK ANALYSIS ................................................................................... 15 
4.1 
Adverse event reporting ..................................................................... 15 
4.2 
Withdrawal of subjects ....................................................................... 15 
5.0 
MONITORING PROCEDURES ............................................................. 15 
6.0 
INFORMED CONSENT ......................................................................... 16 
7.0 
IRB INFORMATION .............................................................................. 16 
8.0 
ADDITIONAL RECORDS AND REPORTS .......................................... 17 
8.1 
Data handling and record-keeping ..................................................... 17 
8.2 
Record maintenance and retention .................................................... 18 
9.0 
STUDY RESULTS AND PUBLICATION .............................................. 19 

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9.1 
Ownership of Study Results ............................................................... 19 
9.2 
Communication of Study Results ...................................................... 19 
10.0 
PUBLICATIONS AND PRESENTATIONS ........................................... 19 
References ........................................................................................................ 19 
APPENDIX I ....................................................................................................... 20 

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LIST OF ABBREVIATIONS 
 
AE 
CRF 
CT 
Adverse Event 
Case Report Form 
Computed Tomography 
FDA 
Food and Drug Administration 
FDG 
18F-Fluorodeoxyglucose 
FOV 
Field of View 
GCP 
Good Clinical Practice 
IRB 
MTV 
NM 
PET 
Institutional Review Board 
Metabolic Tumor Volume 
Nuclear Medicine 
Positron Emission Tomography 
QA 
QC 
Quality Assurance 
Quality Control 
Study PIs 
Study Principal Investigators 
TLG 
VOI 
ROI 
WB 
SUV 
Total Lesion Glycolysis 
Volume of Interest 
Region of Interest 
Whole Body 
Standardized Uptake Value 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SYNOPSIS 
 
 
TITLE 
A Study to Assess the Impact of Moderate/Significant 
Infiltrations on the Standardized Uptake Values of Target 
Lesions 
SPONSOR 
Lucerno Dynamics, LLC 
NUMBER OF SITES 
1 
RATIONALE 
A widely used semi-quantitative parameter to assess 
tumor status is the standardized uptake value (SUV). 
SUV estimation accuracy can be impacted by many 
variables. Today there still exists a significant amount of 
variability in PET/CT results in test and re-test studies. 
This variability can be introduced by instrumentation and 
subject-specific factors. Variability reduces image quality 
and increases the required changes in tumor 
quantification to reflect real tumor response or 
progression.  
 
PET/CT scanning process requires that the entire net 
injected dose of radiolabeled tracer is administered 
intravenously as a bolus. The quality and quantification of 
a PET/CT image is highly dependent on the uptake of 
radiolabeled tracer. Boellaard et al. have indicated 
infiltrations could potentially underestimate SUV 
measurements by as much as 50%. Infiltrations and 
obstructions are not uncommon.  
STUDY DESIGN 
This is a prospective single-center study with no 
therapeutic intent. 
PRIMARY 
OBJECTIVE 
To characterize impact of moderate or greater infiltrations 
on standardized uptake values. 
EXPLORATORY 
OBJECTIVES 
To estimate the impact that infiltrations may have on 
initial assessment and/or response assessment in 
accordance with PERCIST criteria.  
To estimate the effect of moderate or greater infiltrations 
on metabolic tumor volume and total lesion glycolysis. 
 
 
 

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NUMBER OF 
SUBJECTS 
The number of subjects will be determined based on the 
number of moderate or greater infiltrations at the site. 
SUBJECT 
SELECTION 
CRITERIA 
Inclusion Criteria: Subjects with solid tumors or 
lymphoma undergoing PET/CT scan who have at least 
one measurable target lesion and sustain a moderate or 
greater infiltration.  
 
Exclusion Criteria: Subjects unwilling or unable to 
tolerate a repeat PET/CT scan. Subjects with meaningful 
medical intervention between PET/CT scans that would 
likely impact SUV. Subjects with follow up moderate or 
severe injection infiltrations that would likely impact the 
SUV. Patients for whom an infiltration score cannot be 
determined, such as when ports or other central lines are 
used. Pregnant patients. Subjects who are not able to 
read/understand English. 
 
DURATION OF 
SUBJECT 
PARTICIPATION AND 
DURATION OF 
STUDY 
Patients who experience a moderate or greater infiltration 
will be invited for a repeat PET/CT scan. Subject 
participation in this study is limited only to the few minutes 
they are questioned after their first scan and before their 
repeat scan, and for the time it will take for the repeat 
scan. These questions are designed to try and ensure 
both scans were conducted under similar subject 
conditions (fasting levels, prior activity levels, etc.) The 
questions should not require more than 15 minutes total. 
Final data analysis will be completed within 3 months of 
enrolment of the final subject. 
STATISTICS 
Primary Analysis 
Plan 
Analyses will be descriptive in nature because the sample 
size of the group who will return for re-testing is 
challenging to forecast a priori. We anticipate enrolling up 
to 20 patients in 12 months based on the infiltration rate 
at WFB and accounting for ongoing quality improvement 
efforts. 
Rationale for Number 
of Subjects 
All subjects undergoing PET/CT who experience a 
moderate or greater infiltration will be invited back for a 
repeat scan. 
 
 
 
 

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1.0 
INTRODUCTION AND BACKGROUND 
 
PET/CT scanning is becoming progressively more important to the management of 
patients with cancer due to its accuracy and convenience in presenting anatomical and 
functional information. Oncology PET/CT scans are often used to stage cancer and 
assess therapy response. Quantification of PET/CT results is increasingly being used. A 
widely used semi-quantitative parameter to assess tumor status is the standardized 
uptake value (SUV). SUV estimation accuracy can be impacted by many variables. 
Therefore, producing high quality PET/CT images requires rigorous protocols of image 
acquisition and analysis.  
 
Today, there still exists a significant amount of variability in PET/CT results in test and 
re-test studies [1]. This variability can be introduced by instrumentation and patient-
specific factors. Variability reduces image quality and increases the required changes in 
tumor quantification to reflect real tumor response or progression. Weber’s recent multi-
center study of NSCLC found a 30% SUV decrease (in defining therapeutic response) 
or a 40% SUV increase (in defining progression) is required to have confidence that the 
results are indicative of metabolic response or metabolic progression, rather than a 
reflection of variability in the measurement of the PET/CT process [2]. 
 
Accurate SUV calculation requires that the entire net injected dose of radiolabeled 
tracer is administered intravenously as a bolus. The quality and quantification of a 
PET/CT image is highly dependent on the uptake of radiolabeled tracer. Boellaard et al. 
have indicated infiltrations could potentially underestimate SUV measurements by as 
much as 50% [3]. Infiltrations and obstructions are not uncommon. Single center studies 
have demonstrated that improper injections of radiolabeled tracer for PET can occur in 
10 - 21% of cases [4, 5, 6].  
 
Recent studies using a novel QA/QC tool (LaraTM System) for the radiotracer injection 
process revealed that current means to detect infiltration do not completely identify all 
infiltrations/obstructions [7]. Since infiltrations may not be visible in the standard field of 
view (FOV) and since the impact of a peripheral circulatory obstruction may not be 
visible even if an injection site is in the FOV, it is possible for reading and treating 
physicians to be unaware that a patient’s image and quantification has been impacted. 
Additionally, when current means do detect an infiltration, they under-represent the 
severity because they are not capturing that infiltrations often resolve during the uptake 
period. As a result, infiltrations or obstructions may cause SUV inaccuracy and could 
adversely impact staging and tumor assessments.  
 
The FDA-listed Lucerno Dynamics LaraTM System is comprised of sensors, a reader and 
software. The sensors are connected to a reader that provides temporary data storage. 
By using similar principles as PET scanning technology (i.e., scintillating crystal and 
photomultiplier), the sensors measure the presence of radiolabeled tracer in target 
areas of interest. The system software that has been developed uses time activity 
curves (TACs) to provide a way to determine whether radiolabeled tracers commonly 
used in PET/CT remain pooled near the injection site during the uptake period, rather 

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than circulating in the vascular system. Past and ongoing studies using standard 
PET/CT and dynamic images have confirmed the Lara™ System is a better tool than 
current imaging to identify and characterize the presence of radiotracer near the 
injection site during uptake.  Because the LaraTM sensor is located near the injection 
site, it captures all infiltrations and obstructions and is agnostic to imaging FOV.  With a 
one second frame rate, LaraTM dynamically captures radiotracer presence during the 
entire uptake period, and therefore better characterizes infiltrations as compared to 
static images taken at 60 minutes post injection. Lara’s TAC feedback on the fidelity of 
an FDG injection of the entire uptake period could help reduce erroneous infiltration 
interpretations.  
 
Because Lara will be able to better identify and characterize moderate or greater 
infiltrations, Lucerno will assist the clinical site in the design and execution of a study to 
assess impacts of these infiltrations. All medical management of subjects participating 
in this research is at the discretion of the site medical care team and is not part of the 
research protocol. 
 
2.0 
PURPOSE OF THE STUDY 
 
A widely-used parameter to quantify uptake of radiolabeled tracer is the standardized 
uptake value (SUV), calculated by normalizing radiolabeled tracer activity concentration 
in a volume of interest (VOI) to the decay-corrected injected activity and body mass. 
SUVs allow semi-quantitative evaluation of disease and therapy response. Accuracy of 
SUV estimation assumes the entire net injected dose is administered intravenously as a 
bolus injection. Improper injections have been shown in previous studies to impact SUV 
measurements [3, 4]. In the few published studies measuring infiltration rates in PET, 
radiolabeled tracer infiltration occurs in 10–21% of clinical exams [4, 5, 6]. Phase 1 of 
an ongoing quality improvement project at Wake Forest Baptist Health using the LaraTM 
device has shown an infiltration rate of 13.3%. Additionally, infiltrations may impact a 
reading physician’s ability to properly stage a patient’s cancer, since metastatic lesions 
may not be visible in infiltrated cases.  
 
The purpose of this study will be to characterize the impact of moderate or greater 
infiltrations on standardized uptake values. 
 
 2.1 
Objectives of the study   
 
2.1.1 Primary Objective 
To characterize impact of moderate or greater infiltrations on standardized uptake 
values of solid tumors or lymphoma. 
 
 

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2.1.2 Exploratory Objectives 
• To estimate the impact that infiltrations may have on initial assessment and/or 
response assessment in accordance with PERCIST criteria. 
• To estimate the effect of moderate or greater infiltrations on metabolic tumor volume 
and total lesion glycolysis. 
 
2.2.  Anticipated duration of the study 
 
Participation in the study is limited to the time from the baseline PET/CT to the repeat 
PET/CT scan which is anticipated to be no more than one week. While subjects will only 
answer questions for a total of less than 15 minutes to try and ensure the conditions for 
each PET/CT scan are standardized as much as possible, these two sessions of 
questions may be 1 to 7 days apart. Patient accrual will be closed after 12 months. 
 
3.0 
PROTOCOL 
 
3.1 
Protocol number and title  
LUC-2017-001 A Study to Assess the Impact of Moderate/Significant Infiltrations on the 
Standardized Uptake Values of Target Lesions  
 
3.2 
Protocol version number and date  
Version 0, December 19, 2017 
   
3.3 
Project design 
This is a prospective, single-center, study with no therapeutic intent. 
 
3.4 
Subject selection 
 
3.4.1 Inclusion criteria 
Subjects with solid tumors or lymphoma undergoing F-18 FDG PET/CT scan who 
have at least one measurable target lesion and sustain a moderate or greater 
infiltration.  
 
3.4.2  Exclusion criteria 
• Subjects unwilling or unable to tolerate a repeat PET/CT scan.  
• Subjects with meaningful medical intervention between PET/CT scans that 
would likely impact SUV.  
• Subjects with follow-up moderate or greater infiltrations as determined by 
the PI and Lara score. 
• Patients for whom an infiltration score cannot be determined, such as 
when ports or other central lines are used. 

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• Pregnant women. 
• Subjects who are not able to read/understand English 
 
3.4.3 Anticipated number of subjects 
All subjects who experience a moderate or severe infiltration will be invited back 
for a repeat scan. Based on historical data, Wake Forest Baptist quality 
improvement initiatives have been implemented to reduce the number of 
infiltrations. We would therefore estimate up to 20 subjects in the next twelve 
months. Data will also be captured on the CRF for any patients who return for 
additional follow-up scans (after completing the test/re-test portion of the study). 
 
 
3.5 
Study procedure 
 
The LaraTM System is currently commercially available and is being used on site as part 
of a Quality Improvement project on all patients undergoing PET/CT studies. The LaraTM 
System will continue to be used on all patients undergoing PET/CT scans at the 
completion of the Quality Improvement Study to provide ongoing quality control and 
quality assurance of the injection process. Patients whose scans are determined by the 
Nuclear Medicine physician, or their designee, to have a moderate or greater infiltration 
based on review of the standard PET images and/or LaraTM TACs will be asked to 
return for a repeat PET/CT scan within 1-7 calendar days. In the event that the follow up 
scan shows any infiltration; the Nuclear Medicine physician or designee will be 
consulted to determine appropriate next steps. Site will duplicate the PET/CT protocol of 
the initial scan as carefully as possible for the follow up scan. Factors that will help 
ensure consistency of scan conditions to be recorded on the Case Report Form (CRF) 
(Appendix 1) include (but are not limited to): 
 
• Same pre-procedure process and instructions to subject 
• Time of day 
• Glucose 
• Time from injection to scanning 
• PET/CT bed protocol 
• Fasting and pre-scan activity level 
• Subject weight 
• BMI 
• Prescribed FDG dose 
• Flush volume 
• Concomitant medications 
• Any other data deemed pertinent by the technologist and/or Nuclear Medicine 
physician 
 

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3.5.1 Withdrawal of subjects due to non-compliance 
Non-compliance will only occur if a subject does not follow the same pre-PET/CT 
scan guidance that they followed for their initial scan. In the event of reported 
non-compliance by a subject, the Nuclear Medicine physician will be consulted 
on appropriate action to take. 
 
3.5.2 Procedures to assess efficacy 
The study does not involve evaluation of efficacy. 
 
3.5.3 Procedures to assess safety 
The study does not involve evaluation of safety. 
 
3.5.4 Schedule of study visits 
Patients who are determined to have a moderate or greater infiltration on their 
routinely ordered PET scan will be invited back for a repeat scan within 7 days of 
the initial scan. 
 
3.6 
Study Objectives 
 
3.6.1 Primary Objective 
To measure the impact of moderate (or greater) infiltrations on standardized 
uptake values. 
 
3.6.2 Exploratory Objectives 
• To estimate the impact that infiltrations may have on initial assessment 
and/or response criteria assessment in accordance with PERCIST criteria. 
• To measure the impact of moderate or greater infiltrations on metabolic 
tumor volume and total lesion glycolysis. 
 
3.6.3 Sample size determination 
The sample size of the group who will return for re-testing is challenging to 
forecast a priori due to ongoing quality improvement efforts to reduce infiltrations 
The study will enroll patients for up to 12 months, or will be terminated at 20 
patients if reached in less than 12 months. 
 
3.6.4 Data Analysis 
Upon the determination of an infiltrated subject, the technical staff will notify the 
Nuclear Medicine physician to determine the severity and appropriateness of the 
subject for the study. To qualify for the study, the subject will need:  
• at least one target lesion; and 

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• at least a moderate infiltration as determined by visual analysis and/or 
infiltration score from the Lucerno Dynamics’ LaraTM system software 
 
Data will be analyzed on each individual subject after the second imaging 
session. The scans will be presented in tandem such that simultaneous 
measurements may be performed using a qualified image analysis program, 
such as MIM version 6.5.  Up to five target lesions will be assessed, chosen to 
include the target lesion or lesions defined under the PERCIST criteria [8]. For 
each lesion, SUV peak will be measured, and a volume contour will be created 
using mean liver SUV+2SD as a threshold., SUVmean, metabolic tumor volume, 
and total lesion glycolysis will be measured from the contour. The lesions chosen 
will be the same for each scan, however differences in the scans may affect the 
volume contour. Liver and blood pool measurements will also be made as for 
PERCIST criteria. 
 
SUV will be descriptively compared for the original and re-test. Our expectation is 
that SUV will increase at the re-test, although we are not amply powered to 
conduct a rigorous statistical test. We will also evaluate the relationship between 
SUV values and the Lara score by computing a Pearson's correlation coefficient.   
We hypothesize this correlation will be positive. 
 
We hypothesize that presence of venous stasis (a cessation or impairment of 
venous flow) may have an influence on the relationship on SUV scores.   We will 
conduct a sensitivity analysis by conducting analyses with and without stasis 
cases.   Specifically, we will compare the % change in SUV values between test 
and re-test and the correlation coefficient of % SUV change and Lara score in the 
samples including and excluding stasis cases. 
 
To assess the exploratory objective of whether extravasation of radiotracer could 
influence initial staging, for patients where the type of primary solid tumor is 
known the T, N, and M stages will be assessed to the extent possible by PET/CT 
for each scan and an overall stage assigned. This will be done even if the scan 
was performed for response assessment or follow up. No additional imaging or 
clinical information will be used and it is recognized that this assessment may not 
generate the true clinical stage. However, the comparison between the two scans 
will still provide information regarding the risk of changing stage based on missed 
or mischaracterized lesions after an extravasation event. To provide more 
granular information, the number of FDG avid regional nodes and number of 
FDG avid non-nodal metastases (capped at 25 each) will also be recorded for 
each scan.  
 
For the exploratory objective of whether extravasation can influence apparent 
response to therapy, we will use the infiltrated and repeat scans to explore the 
impact of infiltrations on PERCIST criteria if there is an existing PET/CT scan for 

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comparison. This other PET/CT scan could either be a prior or a follow-on 
PET/CT scan that has a Lara-validated injection.  
 
All scans will be analyzed by a qualified Nuclear Medicine physician and reported 
using the study imaging charter. Any measurements made for the clinical reports 
will not be used for this analysis. To mitigate bias, a second blinded radiologist 
will independently analyze the scans.  
4.0 
RISK ANALYSIS 
 
Minimal risk to the patient arises from exposure to radiation from one additional 
PET/CT. There are no anticipated risks associated with the effort to help assure both 
PET/CT scans protocols are as similar as possible. It is possible that the repeat scan 
will reveal additional abnormalities not seen on the initial scan, which could cause 
psychological distress. There is a theoretical risk of disclosure of protected health 
information. To minimize this risk, all data collection will be performed in the Nuclear 
Medicine department. Limited PHI will be included in the research record, and all data 
will be stored on encrypted devices per heath center policy. A log of study accession 
numbers, which could reidentify patients through the electronic medical record, coupled 
to study patient identifier will be maintained on an encrypted device to allow auditing of 
the data. The study team will comply with all site procedures and policies to protect 
confidentiality and minimize any risk to subject privacy. 
 
4.1 
Adverse event reporting  
 
Serious Adverse Events will be reported and recorded with the patient data on the 
Adverse Event Form. Any serious adverse event, including loss of confidentiality, will be 
reported to the IRB per site requirements, and to the study sponsor within 24 hours of 
knowledge of the event. There are no experimental drugs or devices being used in this 
study.  
 
4.2 
Withdrawal of subjects  
Any subject in the study may withdraw from the study at any time. In such cases the 
reason for withdrawal will be recorded and determination will be made by the site PIs as 
to its association with the research.  
 
5.0 
MONITORING PROCEDURES 
Monitoring of the study for compliance with the clinical protocol and with FDA 
regulations will include at least one on-site visit by clinical staff of Lucerno. The Study 
PIs will permit direct access of the study monitor and appropriate regulatory authorities 
to the study data and any corresponding source documents to verify the accuracy of the 
data.  
 

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6.0 
INFORMED CONSENT 
 
Subject consent will be obtained for all subjects willing to participate in the clinical study. 
No study procedures (data collection) may be done until the subject has provided a signed 
informed consent. The consent form will contain non-technical language describing the 
study procedures.  
Once a potential subject has been identified for study participation (a moderate or greater 
infiltration has been noted), the Investigator or authorized designee will approach the 
subject to explain the purpose and scope of the clinical study, along with prospective 
risks, and benefits of participation. The subject must be given the opportunity to ask 
questions about the study and must be given sufficient time to decide to participate in the 
study or not. Any additional information requested by the prospective subject should be 
provided. 
If the subject agrees to participate, the informed consent form must be signed and 
personally dated by the subject. The investigator or an authorized member of the research 
team who has witnessed the subject’s signature must also sign and date the informed 
consent, prior to enrollment of the subject. A copy of the completed informed consent 
form must be provided to the subject. Local IRB regulations regarding obtaining informed 
consent must be followed. The subject’s medical record should have a notation regarding 
the signing of the informed consent. 
If a subject is unable to provide written consent due to limitations in ability to read or write, 
informed consent shall be obtained with the subject’s LAR (legally authorized 
representative) and an independent witness shall be present throughout the process. The 
written informed consent form and any other information shall be read aloud and 
explained to the subject and, whenever possible, the subject shall sign and personally 
date the informed consent form. The witness also signs and personally dates the informed 
consent form attesting that the information was accurately explained, and that informed 
consent was freely given. 
The consent form will include patient authorization to release PHI limited to that collected 
in the study to Lucerno Dynamics. 
7.0 
IRB INFORMATION 
The protocol will be reviewed and approved by the site IRB prior to study initiation.  
Adverse events will be reported to the IRB in accordance with the standard operating 
procedures and policies of the IRB. 
 
Any documents that the IRB may need to fulfill its responsibilities (such as protocol, 
protocol amendments, information concerning subject recruitment, payment or 
compensation procedures, or other pertinent information) will be submitted to the IRB.  
The IRB’s written unconditional approval of the study protocol will be in the possession 
of the Study PIs before the study is initiated.  The IRB’s unconditional approval 
statement will be transmitted by the Study PIs to Lucerno prior to study initiation.  This 

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approval must refer to the study by exact protocol title and number and should identify 
the documents reviewed and the date of review. 
 
Protocol modifications or changes may not be initiated without prior written IRB approval 
except when necessary to eliminate immediate hazards to the subjects or when the 
change(s) involves only logistical or administrative aspects of the study.  Such 
modifications will be submitted to the IRB and written verification that the modification 
was submitted and subsequently approved should be obtained.   
 
The IRB must be informed of revisions to other documents originally submitted for 
review; new information that may affect adversely the safety of the subjects of the 
conduct of the study; an annual update and/or request for re-approval; and when the 
study has been completed. 
 
 
8.0 
ADDITIONAL RECORDS AND REPORTS  
  
8.1 
Data handling and record-keeping 
Data will be captured using the LaraTM System, the site PET/CT scanner and a study 
CRF. Other than the scintillation data captured, the following information is also 
captured via drop down menus on the home screen at the time of data download: 
 
Subject Height - in or cm 
  
Subject Mass – lb. or kg 
 
Subject Age Group: <16, 16-49, 50-69, >70 
 
Subject Glucose: 
 
Radiotracer: 
 
Dose (mCi): 
 
NM Technologist performing the injection 
 
Flush Volume: 
Injection Orientation – Unknown, Right, Left 
    
Injection Locations – Unknown, Antecubital, Forearm, Hand, Wrist, Foot, Port, Other 
 
Injection Technique – Unknown, Butterfly, IV, IV Drip, Straight Stick, Other 
 
Auto Injection – Unknown, No, Yes 

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Needle Gauge – Unknown, 14, 16, 18, 20, 22, 23, 24, 25 
 
At the time of data entry, the NM Technologist enters the subject’s identifying hospital 
record number. This number is cross-referenced to a Lucerno identification number to 
allow the site to identify the subject and match the data with the subject. The cross 
reference between the hospital and Sponsor numbers is recorded at the site. Only 
Lucerno’s identification number is transmitted, with other collected data, to the Lucerno 
server. The transmission is encrypted and contains no Protected Health Information.  
 
Completed case report forms will be scanned and sent via secure e-mail to Lucerno 
Dynamics on a pre-determined schedule. All study documents, including paper case 
report forms will be kept in a secured, locked location at Wake Forest Baptist Medical 
Center.  
 
8.2 
Record maintenance and retention  
Lucerno and the Study PIs will maintain records to include: 
• 
IRB correspondence (including approval notifications) related to the clinical 
protocol including copies of adverse event reports and annual or interim reports 
• 
Current and past versions of the IRB-approved clinical protocol and any protocol 
amendments 
• 
Signed Study PIs Agreements and Certifications of Financial Interests of Clinical 
Investigators 
• 
Curriculum vitae (Study PIs and any clinical protocol sub-investigators) 
• 
Certificates of required training (e.g., human subject protections, Good Clinical 
Practice, etc.) for the Study PIs and key staff 
• 
Source Documents or certified copies of Source Documents 
• 
Monitoring visit reports 
• 
Copies of study correspondence including any notifications of adverse effect 
information 
• 
Subject screening and enrollment logs 
• 
Subject Case Report Forms 
• 
Signed Subject Informed Consent Forms 
• 
Subject identification code list 
• 
Final report 
 
Lucerno and Study PIs will retain the specified records and reports for at least two years 
following completion of the study. No records will be destroyed without explicit 
permission from Lucerno Dynamics. 

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9.0 
STUDY RESULTS AND PUBLICATION 
 
9.1 
Ownership of Study Results 
Site and Lucerno shall jointly own all study data, reports and the results of the study 
("study results") as described in the SUV Study Agreement. 
 
9.2 
Communication of Study Results  
Lucerno will abide by all applicable laws regarding communication of safety information 
and study results as described in the SUV Study Agreement. 
10.0 PUBLICATIONS AND PRESENTATIONS 
The Study PIs shall register the study on any appropriate public registries, such as 
clinicaltrials.gov, as required by applicable law or regulation. Publication of the study 
results will be a joint responsibility between Lucerno and the Study PIs. 
 
References 
 
1. 
Lodge, MA. Repeatability of SUV in Oncologic 18F-FDG PET. J Nucl. Med.  
2017;58:523-532 
2. 
Weber, WA, Gatsonis, CA, Mosley, PD et al. Repeatability of 18F-FDG 
PET/CT in advanced non-small cell lung cancer: prospective assessment in 2 
multi-center trials. J Nucl. Med.  2015;56:1137-1143. 
3. 
Boellard, R. Standards for PET image acquisition and quantitative data 
analysis. J. Nucl. Med. 2009;50 (Suppl. 1), 11S – 20S. 
4. 
Hall, N. C., Zhang, J., Reid, R., Hurley, D. and Knopp, M. V. (2006) 
Impact of FDG extravasation on SUV measurements in clinical PET/CT. 
Should we routinely scan the injection site? J. Nucl. Med. 47 (Suppl. 1) 115P 
5. 
Osman MM, Muzaffar R, Altinyay ME, Teymouri C. FDG dose extravasations 
in PET/CT: frequency and impact on SUV measurements. Front Oncol. 
2011;1:41. doi:10.3389/fonc.2011.00041. 
6. 
Silva-Rodriguez J, Aguiar P, Sanchez M, Mosquera J, Luna-Vega V, Cortes 
J, et al. Correction for FDG PET dose extravasations: Monte Carlo validation 
and quantitative evaluation of subject studies. Med Phys. 2014;41(5):052502. 
doi:10.1118/1.4870979. 
7. 
Data on file – Lucerno Dynamics, LLC. 
8. 
Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: 
Evolving Considerations for PET response criteria in solid tumors. J Nucl Med 
2009;50(Suppl 1):122S–150S. 
 
 
 
 

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APPENDIX I 
 
Case Report Form