Clinical trial NCT03125629
Conditions: Cancer Diagnosis Diagnostic Techniques and Procedures Diagnostic Imaging
Sponsor: Stanford University
Start date: 2014-05-27; Completion date: 2020-02-05
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial studies how well positron emission tomography (PET)/computed tomography (CT) works compared to PET/magnetic resonance imaging (MRI) in evaluating patients with cancer. PET/CT and PET/MRI may determine which scanner is best for the patient's type of cancer and other types of cancers.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate if PET/CT and PET/MRI scanners provide equivalent results for evaluation of cancer patients.

OUTLINE:

Patients receive standard of care 18F-fludeoxyglucose (FDG) or Ga68-DOTA-TATE intravenously (IV). Within 45-60 minutes, patients then undergo PET/CT imaging immediately followed by PET/MRI. Each participant is to receive 18-FDG or 68Ga-DOTA-TATE only, no participant was to receive both radiotracers.

Arms: arm 1: Participants will undergo a PET/CT scan with radiolabel 18F-FDG. arm 2: Participants will undergo a PET/MRI scan with radiolabel 18F-FDG. arm 3: Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE. arm 4: Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.
Interventions: intervention 1: F-18 FDG intervention 2: Ga-68-DOTA-TATE intervention 3: Positron Emission Tomography / Computed Tomography (PET/CT) Scan intervention 4: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan
Intervention descriptions: intervention 1: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging intervention 2: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging intervention 3: Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner. intervention 4: Scan using a NOVEL GE PET/MRI scanner.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
Comparison of PET/CT vs. PET/MRI 
 
 
Principal Investigator: 
 
Andrei Iagaru, MD 
300 Pasteur Drive, Room H-2230 
Stanford, CA 94305 
Phone: 650 725 4711 
Fax: 650 498 5047 
Email: aiagaru@stanford.edu 
 
Co-investigators: 
 
Sandip Biswal, MD, PhD 
Sanjiv Sam Gambhir, MD, PhD 
Garry Gold, MD 
Robert Herfkens, MD 
Erik Mittra, MD, PhD 
Andrew Quon, MD 
Shreyas Vasanawala, MD, PhD 
Greg Zaharchuk, MD, PhD 
 
 
Biostatistician: 
 
Alex McMillan, PhD 
 
Study Coordinators: 
 
Euodia Jonathan, BS 
Phone: xxxxxxxxxxx 
Fax: 650 498 5047 
Email: xxxxxxxxxxxxx 
 
Lindee Burton, BS 
Phone: xxxxxxxxxxxx 
Fax: 650 498 5047 
Email: xxxxxxxxxxx 
 
 
 
SRC Approved Protocol / Version #3 / April 22, 2016 
 
NCT03125629 
 
 
 
 


SRC Version 3 
2 
April 22, 2016 
 
 
 
TABLE OF CONTENTS 
 
SCHEMA ...................................................................................................................................... 4 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ........................................................ 5 
1. OBJECTIVES ........................................................................................................................ 6 
Primary Objective .................................................................................................................. 6 
Secondary Objectives ........................................................... Error! Bookmark not defined. 
2. BACKGROUND ..................................................................................................................... 6 
Preliminary information ......................................................................................................... 6 
Study Agent ........................................................................................................................... 6 
Clinicaltrials.gov .................................................................................................................... 6 
Rationale ............................................................................................................................... 6 
Study Design ......................................................................................................................... 6 
3. PARTICIPANT SELECTION AND ENROLLMENT PROCEDURES ..................................... 7 
Inclusion Criteria ................................................................................................................... 7 
Exclusion Criteria .................................................................................................................. 7 
Informed Consent Process .................................................................................................... 7 
Study Timeline ...................................................................................................................... 7 
3.1.1. Primary Completion: ............................................................................................... 7 
4. IMAGING AGENT INFORMATION........................................................................................ 7 
Study Agent ........................................................................................................................... 7 
Specify the source of the study agent. .................................................................................. 7 
Describe how the agent will be requested and provide mailing address and phone number.
 .............................................................................................................................................. 8 
Agent Accountability .............................................................................................................. 8 
5. IMAGING SPECIFICS ........................................................................................................... 8 
 Modality or Modalities to be used .......................................................................................... 8 
 Details of Imaging (i.e. dynamic, static, number of scans, etc.) ............................................. 8 
 Details of processing/analysis ............................................................................................... 8 
6. STUDY PROCEDURES ........................................................................................................ 9 
 Criteria for Removal from Study ............................................................................................ 9 
7. STUDY CALENDAR .............................................................................................................. 9 
8. ADVERSE EVENTS AND REPOR650TING PROCEDURES ............................................. 10 
Potential Adverse Events .................................................................................................... 10 
Adverse Event Reporting .................................................................................................... 10 
9. REGULATORY CONSIDERATIONS................................................................................... 10 
Institutional Review of Protocol ........................................................................................... 10 
Data Management Plan ...................................................................................................... 11 
Data and Safety Monitoring Plan .......................................... Error! Bookmark not defined. 
10.MEASUREMENTS ............................................................................................................. 11 
Primary and Secondary Outcome measures ...................................................................... 11 
Measurement Methods ....................................................................................................... 11 
Measurement Time Points .................................................................................................. 11 
Response Review ............................................................................................................... 11 
Secondary Outcome ............................................................. Error! Bookmark not defined. 
11.STATISTICAL CONSIDERATIONS ................................................................................... 12 
Statistical Design ................................................................................................................. 12 


SRC Version 3 
3 
April 22, 2016 
Randomization .................................................................................................................... 12 
Interim analyses .................................................................................................................. 12 
Descriptive Statistics and Exploratory Data Analysis .......................................................... 12 
Primary Analysis ................................................................................................................. 12 
11.1.1. Analysis Population ............................................................................................. 12 
11.1.2. Analysis Plan ...................................................................................................... 12 
Secondary Analysis ............................................................... Error! Bookmark not defined. 
11.1.3. Analysis Population ............................................... Error! Bookmark not defined. 
11.1.4. Analysis Plan ........................................................ Error! Bookmark not defined. 
Secondary Analysis ............................................................... Error! Bookmark not defined. 
11.1.5. Analysis Population ............................................... Error! Bookmark not defined. 
11.1.6. Analysis Plan ........................................................ Error! Bookmark not defined. 
Sample Size ........................................................................................................................ 12 
Accrual estimates ................................................................................................................ 13 
Criteria for future studies ..................................................................................................... 13 
Appendix:  Inclusion/Exclusion Criteria Checklist ............................................................... 14 
 


SRC Version 3 
4 
April 22, 2016 
 
SCHEMA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eligible participant diagnosed with cancer and referred for 18F FDG or 68Ga DOTA TATE 
PET/CT  
18F FDG or 68Ga DOTA TATE PET/CT  
18F FDG or 68Ga DOTA TATE PET/MRI  


SRC Version 3 
5 
April 22, 2016 
 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
 
FDG 
Fluorodeoxyglucose 
IRB 
Institutional Review Board 
IV 
Intravenous 
PET/CT 
Positron emission tomography – computed 
tomography 
PET/MRI 
Positron emission tomography – Magnetic 
resonance imaging 
ROC 
Receiver-Operative-Characteristic 
SUV 
Standardized Uptake Value 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


SRC Version 3 
6 
April 22, 2016 
1. OBJECTIVES 
 
1.1 Primary Objective 
 
• 
To evaluate if PET/CT and PET/MRI scanners provide equivalent results for evaluation 
of cancer patients 
 
2. BACKGROUND 
 
2.1 Preliminary information 
 
The recent introduction of hybrid PET/MRI scanners in clinical practice (1-3) showed 
promising initial results for several clinical scenarios (4, 5). More than a decade ago, 
multimodality imaging was introduced into clinical routine with the development of the 
PET/CT. Since then, PET/CT has been widely accepted in clinical imaging and has emerged 
as one of the main cancer imaging modalities. With the recent development of combined 
PET/MRI systems for clinical use, a promising new hybrid imaging modality is now 
becoming increasingly available. The combination of functional information delivered by PET 
with the morphologic and functional imaging of MR imaging (e.g., diffusion-weighted 
imaging, dynamic contrast-enhanced MR imaging and MR spectroscopy) offers exciting 
possibilities for clinical applications as well as basic research. However, the differences 
between CT and MR imaging are fundamental. This also leads to distinct differences 
between PET/CT and PET/MRI not only regarding image interpretation but also concerning 
data acquisition, data processing and image reconstruction. PET/MRI is expected to show 
advantages over PET/CT in clinical applications in which MRI is known to be superior to CT 
due to its high intrinsic soft tissue contrast. However, as of now, only assumptions can be 
made about the future clinical role of PET/MRI, as data about the performance of PET/MRI 
in the clinical setting are still limited (6). 
 
2.2 Study Agent 
We will use 18F FDG and 68Ga DOTA TATE as the PET radiopharmaceuticals.  
 
2.3 Clinicaltrials.gov  
18F FDG is an FDA-approved product. Therefore no registration on clinicaltrials.gov is 
required. 68Ga DOTA TATE PET/CT is already registered on clinicaltrials.gov. 
 
2.4 Rationale 
The Division of Nuclear Medicine and Molecular Imaging at Stanford has two of the most 
modern PET/CT scanners from GE Healthcare, the Discovery 600 PET/CT and Discover 
690 PET/CT scanners. There will be a novel GE PET/MRI scanner installed at the Lucas 
Imaging Center. This will be the first of this kind to be produced by GE Healthcare. 
Therefore it is important to determine if PET/CT and PET/MRI scanners provide equivalent 
results for evaluation of cancer patients.  
 
2.5 Study Design 
This is a non-randomized prospective trial. Patients who are referred to Nuclear Medicine for 
evaluation of extent of cancer and are scheduled to undergo the 18F FDG or 68Ga DOTA 
TATE PET/CT will be asked to have the scan repeated on the same day using PET/MRI 
scanner. There will be a single injection of 18F FDG or 68Ga DOTA TATE followed by the 
PET/CT scan and immediately after by the PET/MRI scan. There will be no additional 
radiation to the patient. This is because only one injection of 18F FDG or 68Ga DOTA TATE 
will be given and the MRI uses non-ionizing radiation. 


SRC Version 3 
7 
April 22, 2016 
 
3. PARTICIPANT SELECTION AND ENROLLMENT PROCEDURES 
3.1 Inclusion Criteria 
• 
Patient is ≥ 18 years old at the time of the scan  
• 
Patient provides written informed consent 
• 
Patient is diagnosed with cancer  
• 
Patient is capable of complying with study procedures 
• 
Patient is able to remain still for duration of imaging procedure (approximately 90 
minutes total for PET/CT and PET/MRI)  
 
3.2 Exclusion Criteria 
• 
Patient is < 18 years old at the time of the drug administration 
• 
Patient is pregnant or nursing 
• 
Metallic implants (contraindicated for MRI) 
• 
Renal function impairment preventing administration of MRI contrast 
 
3.3 Informed Consent Process 
 
All participants will be provided a consent form describing the study with sufficient 
information for participants to make an informed decision regarding their participation. 
Participants must sign the IRB approved informed consent prior to participation in any study 
specific procedure. The participant must receive a copy of the signed and dated consent 
document. The original signed copy of the consent document must be retained in the 
medical record or research file.  
 
3.4 Study Timeline 
 
3.4.1 Primary Completion: 
The study will reach primary completion 24 months from the time the study opens to 
accrual. 
 
3.4.2. Study Completion: 
The study will reach study completion 48 months from the time the study opens to 
accrual. 
 
4. IMAGING AGENT INFORMATION 
 
4.1 Study Agent  
 
We will use 18F FDG or 68Ga DOTA TATE as the PET radiopharmaceuticals. These will be 
used as standard of care. The administered dosage is 10-12 mCi iv for 18F FDG and 5-7 mCi 
for 68Ga DOTA TATE. 
 
4.2 Specify the source of the study agent.  
 
Molecular Imaging Program at Stanford 
Lucas Cyclotron Radiochemistry Facility  
1201 Welch Road, Room PS049 
Stanford, CA 94305-5484  
 


SRC Version 3 
8 
April 22, 2016 
4.3 Describe how the agent will be requested and provide mailing address and phone 
number. 
 
Ordered in Radiology Information System (RIS), address per above. 
 
4.4 Agent Accountability 
 
RIS is password protected and part of the electronic medical records.  
5. IMAGING SPECIFICS  
5.1 Modality or Modalities to be used 
 
PET/CT & PET/MR 
 
5.2 Details of Imaging (i.e. dynamic, static, number of scans, etc.) 
Whole-body (skull base to mid-thighs) PET/CT images will be obtained using the GE 
PET/CT 600 and 690 scanners (GE Healthcare) per standard oncologic protocols (7). In 
brief, PET/CT images will be acquired in 3D mode at 45-60 minutes after injection of 10-12 
mCi of 18F FDG or 5-7 mCi of 68Ga DOTA TATE. The PET emission scan is corrected using 
segmented attenuation data of the CT scan. The PET images are reconstructed with a 
standard iterative algorithm (OSEM, two iterative steps, 28 subsets) using GE software 
release 5.0. All images are reformatted into axial, coronal, and sagittal views and viewed 
with the software provided by the manufacturer (AW, GE Medical Systems). 
 
Immediately after completion of the PET/CT exam, the patients will be transferred to the 
PET/MRI suite at the Lucas Imaging Center and undergo the PET/MRI image acquisition 
with the least delay. Acquisition will start in the pelvic region and move toward the head. 
First, a localizer MRI scan will be performed to define the table positions. After correct 
positioning of the spatial acquisition windows will be ensured, the combined PET/MRI 
acquisition will be initiated with 3–5 table positions at a 4-min acquisition time per table 
position. First, a coronal 2-point Dixon 3-dimensional volumetric interpolated breath-hold T1-
weighted MRI sequence will be acquired at each table position and used for the generation 
of attenuation maps and for anatomic allocation of the PET results. Simultaneously with the 
start of the Dixon MRI sequence, the PET acquisition will start at the same table position, 
thus ensuring optimal temporal and regional correspondence between MRI and PET data. 
The PET acquisition time will be 4 min per table position, taking delayed acquisition times 
and radioactive decay into account. After completion of the PET acquisition, the table will be 
moved to the next table position and the procedure will be repeated. In the thorax and 
abdomen regions, the MRI scans will be acquired during breath-hold in shallow inspiration, 
similarly to the acquisition of the low-dose CT (8). Other sequences may also be used as 
needed (9). Multiplanar pre- and post-contrast MR images may be obtained at multiple 
stations as needed. Images will be reformatted into axial, coronal, and sagittal views and 
viewed with the software provided by the manufacturer (AW, GE Medical Systems). 
 
5.3 Details of processing/analysis 
The PET/CT scans will be interpreted by ABNM certified Nuclear Medicine physicians, while 
the PET/MRI scans will be reviewed by ABNM certified Nuclear Medicine physicians and 
ABR certified Radiologists. All these investigators have significant clinical experience and 
will be blinded to the participants’ medical history and the results of other imaging 


SRC Version 3 
9 
April 22, 2016 
modalities. Consensus read will be obtained for each scan. Each lesion will be tabulated and 
a comparison of lesion detection by each scanner will be conducted. 
 
6. STUDY PROCEDURES  
6.1 Criteria for Removal from Study 
The Protocol Director may withdraw subjects from the study for one or more of the following 
reasons: failure to follow the instructions of the Protocol Director and/or study staff; 
determination that continuing the participation could be harmful to the subject; the study is 
cancelled or other administrative reasons. 
 
6.2 Alternatives 
 
The alternative is to not participate in the study.  
 
7. STUDY CALENDAR 
 
  
 
 
Pre-
Study 
 
Week 
1 
 
12 
Months 
 
Informed consent 
 
X 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
 
Medical history 
 
X 
 
 
 
 
 
18F FDG or 68Ga DOTA TATE PET/CT 
and PET/MRI done on the same day 
  
 
 
X 
 
 
Data analysis 
  
 
X 


SRC Version 3 
10 
April 22, 2016 
8. ADVERSE EVENTS AND REPORTING PROCEDURES 
 
8.1 Potential Adverse Events 
 
The administration of the radioactive substance will feel like a slight pinprick if given by 
intravenous injection. Patients who are claustrophobic may feel some anxiety while 
positioned in the scanner. Also, some patients find it uncomfortable to hold one position for 
more than a few minutes. The subjects will not feel anything related to the radioactivity of the 
substance in their body. Because the radioactivity is very short-lived, the radiation exposure 
is low. The substance amount is so small that it does not affect the normal processes of the 
body.  
 
There will be a single injection of 18F FDG or 68Ga DOTA TATE followed by 1 PET/CT scan 
and 1 PET/MR scan. There will be no additional radiation to the patient. This is because 
only one injection of 18F FDG or 68Ga DOTA TATE will be given and the MRI uses non-
ionizing radiation. 
 
Magnetic fields do not cause harmful effects at the levels used in the MRI machine. 
However, the MR scanner uses a very strong magnet that will attract some metals and affect 
some electronic devices. All such metallic objects must be removed (if possible) before 
entering the magnet room.  In some cases, having those devices means the patient should 
not have an MRI scan performed. In addition, watches and credit cards should also be 
removed as these could be damaged. There is a possibility that the patient will experience a 
localized twitching sensation due to the magnetic field changes during the scan. This is 
expected and should not be painful. If the patient had a previous reaction to gadolinium-
based contrast agents, a history of severe allergies, or a history of kidney disease, he/she 
should notify the operator/investigator.   
 
8.2 Adverse Event Reporting 
 
We do not anticipate hazardous situations for the subjects as a result of this protocol. 
However, procedures will be in place for verification of correct radiopharmaceutical dose 
and route of administration (i.e., each dose will be double checked for dosimetry and quality 
by a researcher and technologist). The study Principal Investigator (PI) or his designee will 
report unanticipated AEs related to the Stanford CCTO Safety Coordinator within 10 working 
days of becoming aware of the event (5 days if the event is life-threatening or resulted in 
death) using the Adverse Events Communication Form. If the principal investigator 
determines the unanticipated adverse device effect presents an unreasonable risk to 
subjects, the study will be terminated as soon as possible, but no later than 5 working days 
after the PI makes the determination and no later than 15 working days after first receiving 
notification of the effect. 
 
9. REGULATORY CONSIDERATIONS 
 
9.1 Institutional Review of Protocol 
 
 
The protocol, the proposed informed consent and all forms of participant information related 
to the study (e.g. advertisements used to recruit participants) will be reviewed and approved 
by the Stanford IRB. Any changes made to the protocol will be submitted as a modification 
and will be approved by the IRB prior to implementation. The Protocol Director will 
disseminate the protocol amendment information to all participating investigators. 


SRC Version 3 
11 
April 22, 2016 
 
9.2 Data Management Plan 
 
The CRFs will be stored in a locked office in the Nuclear Medicine clinic. Records will be 
kept using OnCore.   
 
During the clinical investigation, the Protocol Director will evaluate the progress of the trial, 
including periodic assessments of data quality and timeliness, participant recruitment, 
accrual and retention, participant risk versus benefit, performance of trial sites, and other 
factors that can affect study outcome.  Monitoring of the trial will occur every 8 weeks and a 
record of monitoring activities will be maintained by the study team.  
 
The Stanford Cancer Institute Data and Safety Monitoring Committee (DSMC) will audit 
study related activities to determine whether the study has been conducted in accordance 
with the protocol, local standard operating procedures, FDA regulations, and Good Clinical 
Practice (GCP).  This may include review of regulatory binders, case report forms, eligibility 
checklists, and source documents.  In addition, the DSMC will regularly review serious 
adverse events and protocol deviations associated with the research to ensure the 
protection of human subjects.  Results of DSMC audits will be communicated to the IRB and 
the appropriate regulatory authorities at the time of continuing review, or in an expedited 
fashion, as needed. 
 
10. MEASUREMENTS 
 
10.1 Primary outcome measure 
 
We will evaluate the maximum standardized uptake value (SUVmax) of 18F FDG or 68Ga 
DOTA TATE in the lesions detected with both scanners. There are now several papers 
based on other vendors' scanners (no GE PET/MRI scanner built yet). The authors showed 
that in oncologic patients examined with PET/CT and PET/MRI, the SUVmax values generally 
correlate well in normal organ tissues. SUVmax derived from PET/MRI can be used reliably in 
clinical routine. Differences observed between MRI and CT derived SUV values may be 
attributed to the time-delay between the PET/CT and PET/MRI scans or biologic clearance 
of radiotracer (10, 11). 
 
10.2 Measurement Methods 
 
Regions of interest will be placed around the lesions using the AW software (GE Healthcare) 
and the SUVmax values from the images acquired with both scanners will be recorded. 
 
10.3 Measurement Time Points 
 
SUVmax values of the lesions will be measured after the scan completion.  
 
10.4 Response Review 
 
The SUVmax values will be analyzed by Nuclear Medicine and Radiology physicians blinded 
to the diagnosis and results of the other scan, in a randomized order to avoid bias. Two 
physicians will review all scans independently. Both scans of a given patients will be 
analyzed by one physician, then separately by the second physician. 


SRC Version 3 
12 
April 22, 2016 
11. STATISTICAL CONSIDERATIONS 
 
11.1. 
Statistical Design 
 
Single arm prospective study of paired imaging studies. 
 
11.2. 
Randomization 
 
This study is to compare the images from two different scanners: PET/CT and PET/MR and 
patients are scanned with both scanners.  No randomization will be done. 
 
11.3. 
Interim analyses 
 
No interim analyses are planned. 
 
11.4. 
Descriptive Statistics and Exploratory Data Analysis 
 
(see below) 
 
11.5. 
Primary Analysis  
 
11.1.1. Analysis Population 
 
 
Analysis population: all lesions identified by either modality (per-lesion analysis). 
 
11.1.2. Analysis Plan 
 
Normal quantile plots of SUVmax for each scanner will be prepared to assess to what extent 
the distribution can be approximated by the normal distribution, and to suggest a suitable 
transformation if not. The distribution of SUVmax for each scanner will be summarized with 
means, standard deviations, range, median and upper and lower quartiles. The distribution 
of the difference (SUVmax_PET/CT – SUVmax_PET/MRI) (difference of transformed values if 
applicable) will likewise be summarized. Cumulative distribution (waterfall plots) may be 
prepared to assist in the evaluation of the results. Patient clinical and demographic 
characteristics will be summarized using relevant summaries (proportions for categorical 
variables, means and standard deviations for continuous variables. 
 
The mean difference plus or minus twice the standard deviation of the difference will be 
calculated as a measure of absolute accuracy. The relative accuracy will be calculated by 
dividing the preceding interval by the arithmetic average of the mean SUVmax of the two 
scanners. The interpretation of these intervals is that we can expect that approximately 95% 
of future differences to lie in these intervals. A paired t-test will be used to aid in the 
interpretation of the results.  Sensitivity analyses may be conducted using linear mixed 
effects models to account for possible clustering of lesions within patients. 
 
The difference of SUVmax measures will be correlated with patient and lesion characteristics 
and with time after injection using the appropriate method (Pearson correlation for 
continuous variables such as age and time from injection, two-sample t-tests for binary 
attributes (sex) and analysis of variance for categorical variables). 
 
11.6. 
Sample Size 


SRC Version 3 
13 
April 22, 2016 
 
Data from Kershah (10) shows coefficients of variation between SUV measurements 
between PET/CT and PET/MRI ranging from 0.21 to 0.51, about 0.33 for CT attenuation 
correction and 0.38 for MR attenuation correction. We present calculations assuming a CV 
of 0.38 for both modalities and a Pearson correlation of 0.5 (moderate scenario) and 0.9 
(optimistic scenario). Assuming a Pearson correlation of 0.5 on the log scale, 200 subjects 
provide 80% power to detect a relative difference of 8% between the SUVmax values using 
the two modalities. With an optimistic assumption of a Pearson correlation of 0.9, 200 
patients provide 80% power to detect a relative difference of 3.4%. These differences do not 
seem minute, they will be a bit larger with only 100 subjects: assuming a Pearson 
correlation of 0.5 on the log scale, 100 subjects provides 80% power to detect a relative 
difference of 11% between the SUVmax values using the two modalities. With an optimistic 
assumption of a Pearson correlation of 0.9, 200 patients provide 80% power to detect a 
relative difference of 5%. 
 
 
11.7. 
Accrual estimates 
 
 
 
We expect the accrual of 100 patients. There are approximately 4500 patients scanned 
each year using PET/CT for cancer, of which approximately 100 patients are Ga68 DOTA 
TATE PET/CT patients. We plan to enroll 15 participants/year and this is easily achievable 
given our experience with other protocols.  
 
11.8. 
Criteria for future studies 
 
 
 
At this time there are no future studies planned beyond the initial 100 participants. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


SRC Version 3 
14 
April 22, 2016 
 
Appendix:  Inclusion/Exclusion Criteria Checklist 
 
 
A
l
l
 
s
S
u
b
j
e
c
t
  
 
 
 
 
 
 
IV. Statement of Eligibility 
This subject is 
 eligible / 
 ineligible for participation in the study. 
 
 
Signature: 
Date: 
Printed Name: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion Criteria 
(From IRB approved protocol) 
Yes 
No 
Supporting Documentation* 
1. Patient is ≥ 18 years old at the time of the 
drug administration 
 
 
      
2. Patient provides written informed consent 
 
 
      
3. Patient is diagnosed with cancer  
 
 
      
4. Patient is capable of complying with study 
procedures 
 
 
      
5. Patient is able to remain still for duration of 
imaging procedure (about one hour) 
 
 
      
Exclusion Criteria 
(From IRB approved protocol) 
 
1. Patient is < 18 years old at the time of the 
drug administration 
 
 
      
2. Patient is pregnant or nursing 
 
 
      
3. Metallic implants (contraindicated for MRI) 
 
 
      
4. Renal function impairment preventing 
administration of MRI contrast (only for 
patients receiving contrast) 
 
 
      


SRC Version 3 
15 
April 22, 2016 
 
REFERENCES: 
 
1. 
Pichler B, Judenhofer M, Wehrl H. PET/MRI hybrid imaging: devices and initial results. 
European radiology. 2008;18(6):1077-1086. 
 
2. 
Zaidi H, Ojha N, Morich M, et al. Design and performance evaluation of a whole-body 
Ingenuity TF PET-MRI system. Physics in medicine and biology. 2011;56(10):3091-3106. 
 
3. 
Boss A, Bisdas S, Kolb A, et al. Hybrid PET/MRI of Intracranial Masses: Initial 
Experiences and Comparison to PET/CT. Journal of Nuclear Medicine. August 1, 2010 
2010;51(8):1198-1205. 
 
4. 
Miese F, Scherer A, Ostendorf B, et al. Hybrid (18)F-FDG PET-MRI of the hand in 
rheumatoid arthritis: initial results. Clinical rheumatology. 2011. 
 
5. 
Boss A, Stegger L, Bisdas S, et al. Feasibility of simultaneous PET/MR imaging in the 
head and upper neck area. European radiology. 2011;21(7):1439-1446. 
 
6. 
Gaertner F, FÃƒÂ¼rst S, Schwaiger M. PET/MR: a paradigm shift. Cancer imaging. 
2013;13:36-52. 
 
7. 
Boellaard R, O’Doherty M, Weber W, et al. FDG PET and PET/CT: EANM procedure 
guidelines for tumour PET imaging: version 1.0. Eur J Nucl Med Mol Imaging. 2010/01/01 
2010;37(1):181-200. 
 
8. 
Drzezga A, Souvatzoglou M, Eiber M, et al. First Clinical Experience with Integrated 
Whole-Body PET/MR: Comparison to PET/CT in Patients with Oncologic Diagnoses. Journal of 
Nuclear Medicine. June 1, 2012 2012;53(6):845-855. 
 
9. 
Hirsch F, Sattler B, Sorge I, et al. PET/MR in children. Initial clinical experience in 
paediatric oncology using an integrated PET/MR scanner. Pediatric radiology. 2013. 
 
10. 
Kershah S, Partovi S, Traughber B, et al. Comparison of Standardized Uptake Values in 
Normal Structures Between PET/CT and PET/MRI in an Oncology Patient Population. 
Molecular imaging and biology. 2013. 
 
11. 
Heusch P, Buchbender C, Beiderwellen K, et al. Standardized uptake values for 
[Ã‚Â¹Ã¢ÂÂ¸F] FDG in normal organ tissues: comparison of whole-body PET/CT and PET/MRI. 
European journal of radiology. 2013;82(5):870-876.