Comparison of Standard PET/CT vs. Digital PET/CT
Phase: NA
Conditions: Cancer
Sponsor: Stanford University

 
Comparison of Standard PET/CT Versus Digital PET/CT 
NCT03081767 
January 12, 2021 
Andrei Iagaru, Principal Investigator 
Stanford University 
Stanford, California 94305 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
This is a comparison study of two types of scanners: we want to compare the results of 
the standard-of-care PET/CT scanner with a new digital PET/CT scanner and we plan to 
do this on the same day using a single dose of a radioactive drug that is FDA-approved to 
be used for the PET/CT scan (FDG, NaF, DOTATATE) or radioactive drugs not FDA-
approved but for which we hold INDs (Ga68 PSMA and Ga68 RM2 used in prostate 
cancer).   
 
We hope to learn if the lesions seen using one standard of care scanner (PET/CT) are also 
seen using the novel scanner (digital PET/CT).   
 
The goal of this study is to acquire matched sets of imaging in order to compare the 
standard PET/CT and digital PET/CT. 
b. 
Objectives 
Understanding the imaging characteristics of these two scanners can potentially improve 
the patient care, improving the image quality, by scanning the patients most suitable for 
the individual scanner. Understanding what patients will benefit from digital PET/CT 
instead of standard PET/CT will have the potential to improve patient care. 
c. 
Rationale for Research in Humans 
The scanners are designed for detection of disease in human subjects; therefore, 
comparing the image quality of the two requires human participants. 
2. 
STUDY PROCEDURES 
a. 
Procedures 
Patients who are referred to Nuclear Medicine and are scheduled to undergo standard or 
research (68Ga PSMA or 68Ga RM2) PET/CT on the Discovery 600 or 690 scanner will 
be asked to have the scan repeated on the Discovery MI scanner. Conversely, patients 

January 12, 2021 
 
Page 2 of 13 
who are referred to Nuclear Medicine and are scheduled to undergo standard or research 
(68Ga PSMA or 68Ga RM2) PET/CT on the Discovery MI scanner will be asked to have 
the scan repeated on the Discovery 600 or 690 scanner. There will be a single injection of 
the PET radiopharmaceutical followed by the standard PET/CT scan and immediately 
after by the digital PET/CT scan. A very small amount of radiation (3 mSv) will be given 
by the attenuation correction CT scan in the second PET/CT. 
 
PET/CT images will be obtained using the GE PET/CT 600 or 690 scanners (GE 
Healthcare) per standard oncologic protocols. In brief, PET/CT images will be acquired 
in 3D mode at 45-60 minutes after injection of the radiopharmaceutical. We plan to enroll 
100 patients per year for both SOC and research tracers, for 3 years (total of 300 
patients). The PET emission scan is corrected using segmented attenuation data of the CT 
scan. ToF will be used for patients with BMI>25 (on the 690 system only). The PET 
images are reconstructed both with a standard iterative algorithm (OSEM, two iterative 
steps, 28 subsets), as well as a regularized reconstruction algorithm provided by GE 
Healthcare. All images are reformatted into axial, coronal, and sagittal views and viewed 
with the software available in the Nuclear Medicine and Molecular Imaging Clinic (MIM 
Vista). 
 
Immediately after completion of the standard PET/CT exam, the patients will be 
transferred to the adjacent digital PET/CT suite and undergo the second PET/CT image 
acquisition with the least delay. In brief, PET/CT images will be acquired in 3D mode. 
ToF is standard on the digital PET/CT system. Data driven gating will be acquired 
according to the vendor’s protocol (once commercially available). The PET emission 
scan is corrected using segmented attenuation data of the CT scan. The PET images are 
reconstructed both with a standard iterative algorithm (OSEM, two iterative steps, 28 
subsets), as well as a regularized reconstruction algorithm (Q.Clear®) provided by GE 
Healthcare. All images are reformatted into axial, coronal, and sagittal views and viewed 
with the software available in the Nuclear Medicine and Molecular Imaging Clinic (MIM 
Vista). 
 
The above sequences will be done as well if the digital PET/CT is done first, followed by 
Discovery 600 or 690. 
b. 
Procedure Risks 
No significant risks are associated with the imaging procedures involved. 
c. 
Use of Deception in the Study 
Deception will not be used in this study. 
d. 
Use of Audio and Video Recordings 
Audio and video recording will not be used in this study. 
e. 
Alternative Procedures or Courses of Treatment 

January 12, 2021 
 
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The participant is already referred for standard or research (68Ga PSMA or 68Ga RM2) 
PET/CT. No other alternate procedures are available. The subject can choose not to 
participate in the project. 
f. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
No therapy is used in this study. The protocol will not affect any therapy the patient 
might receive outside this research. 
g. 
Study Endpoint(s) 
No alternative treatments are proposed. 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
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 PET 
detector technology using silicon photomultiplier tubes has become available. The 
combination of functional information delivered by highly sensitive novel PET detectors 
with the morphologic imaging of CT offers exciting possibilities for clinical applications 
as well as basic research. However, the differences between standard and digital PET 
detectors are fundamental. Digital PET/CT is expected to show advantages over standard 
PET/CT by decreasing required dose of PET radiopharmaceuticals, higher sensitivity and 
temporal resolution. However, as of now, only assumptions can be made about the future 
clinical role of digital PET/CT, as data about the performance of digital PET/CT in the 
clinical setting are still limited (1). We recently installed at Stanford University the first 
ever GE-made digital PET/CT worldwide and we plan to compare image quality with 
that from standard PET/CT as part of an investigator initiated research study. 
b. 
Findings from Past Animal Experiments 
Non-available. 
4. 
RADIOISOTOPES OR RADIATION MACHINES 
a. 
Standard of Care (SOC) Procedures 
Identify Week/Month of Study 
Name of Exam 
Identify if SOC or Research 
Once 
standard SPECT/CT 
Standard of Care 
Once 
digital PET/CT 
Research 
b. 
Radioisotopes 
i. 
Radionuclide(s) and chemical form(s) 
68Ga PSMA or 68Ga RM2; patients are consented separately for these studies per 
IRB approved protocols. 

January 12, 2021 
 
Page 4 of 13 
ii. 
Total number of times the radioisotope and activity will be administered (mCi) and 
the route of administration for a typical study participant. 
68Ga PSMA: once, 3-5 mCi 
68Ga RM2: once, 140 MBq 
 
If not FDA approved provide dosimetry information and reference the source 
documents (package insert, MIRD calculation, peer reviewed literature).   
PSMA: 
Measured human dosimetry data are available from the German Cancer Research 
Center in Heidelberg and summarized below. 
Patient 1 Patient 2 Patient 3 Patient 4 Mean 140 MBq 
Adrenals 1.34E-02 1.38E-02 1.39E-02 1.55E-02 1.42E-02 1.98E+00 
Brain 9.84E-03 8.38E-03 8.54E-03 9.11E-03 8.97E-03 1.26E+00 
Breasts 9.71E-03 8.41E-03 8.52E-03 9.16E-03 8.95E-03 1.25E+00 
Gallbladder Wall 1.41E-02 1.48E-02 1.36E-02 1.50E-02 1.44E-02 2.01E+00 
LLI Wall 1.28E-02 1.22E-02 1.21E-02 1.19E-02 1.23E-02 1.72E+00 
Small Intestine 1.59E-02 1.95E-02 1.48E-02 1.49E-02 1.63E-02 2.28E+00 
Stomach Wall 1.21E-02 1.19E-02 1.14E-02 1.25E-02 1.20E-02 1.68E+00 
ULI Wall 2.84E-02 1.16E-01 3.91E-02 3.52E-02 5.47E-02 7.65E+00 
Heart Wall 1.17E-02 1.03E-02 1.04E-02 1.13E-02 1.09E-02 1.53E+00 
Kidneys 1.19E-01 2.79E-01 3.06E-01 3.42E-01 2.62E-01 3.66E+01 
Liver 3.22E-02 2.87E-02 2.65E-02 3.61E-02 3.09E-02 4.32E+00 
Lungs 1.09E-02 9.59E-03 9.66E-03 1.05E-02 1.02E-02 1.42E+00 
Muscle 1.10E-02 1.01E-02 1.01E-02 1.06E-02 1.05E-02 1.46E+00 
Pancreas 1.33E-02 1.36E-02 1.33E-02 1.49E-02 1.38E-02 1.93E+00 
Red Marrow 9.36E-03 8.99E-03 8.87E-03 9.42E-03 9.16E-03 1.28E+00 
Osteogenic Cells 1.53E-02 1.35E-02 1.36E-02 1.45E-02 1.42E-02 1.99E+00 
Skin 9.51E-03 8.39E-03 8.48E-03 9.01E-03 8.85E-03 1.24E+00 
Spleen 2.55E-02 5.61E-02 2.84E-02 6.82E-02 4.46E-02 6.24E+00 
Testes 1.12E-02 9.93E-03 1.02E-02 1.02E-02 1.04E-02 1.45E+00 
Thymus 1.08E-02 9.29E-03 9.43E-03 1.01E-02 9.91E-03 1.39E+00 
Thyroid 1.06E-02 9.09E-03 9.25E-03 9.88E-03 9.71E-03 1.36E+00 
Urinary Bladder Wall 1.22E-01 1.48E-01 1.66E-01 8.74E-02 1.31E-01 1.83E+01 
 
Effective dose 1.83E-02 2.54E-02 2.63E-02 2.42E-02 2.36E-02 3.30E+00 
 
To summarize the results of the published human studies, there were no observed 
adverse events to the radiopharmaceutical. The measured dosimetry showed that the 
critical organ with 68Ga-PSMA is the spleen, followed by the stomach wall, pancreas 
and bladder wall. The effective dose of 68Ga-PSMA reported (0.0236 mSv/MBq) is 
similar to that of 68Ga-DOTA-TOC (0.023 mSv/MBq), 68Ga-DOTA-NOC (0.025 
mSv/MBq), 68Ga-DOTA-TATE (0.021 mSv/MBq) and 68Ga-NOTA-RGD (0.022 
mSv/MBq). 
 
RM2: 

January 12, 2021 
 
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The first-in-human study investigated the safety, tolerability, metabolism, 
pharmacokinetics, biodistribution, and radiation dosimetry of 68Ga-DOTA-
Bombesin (BAY 86-7548). Five healthy men underwent dynamic whole-body 
PET/CT after an intravenous injection of 68Ga-DOTA-Bombesin (138 ± 5 MBq). 
Besides total radioactivity, plasma samples were analyzed by radio–high-
performance liquid chromatography for metabolism of the tracer. Dosimetry was 
calculated using the OLINDA/EXM software. The organs with the highest absorbed 
doses were the urinary bladder wall (0.62 mSv/MBq) and the pancreas (0.51 
mSv/MBq). The mean effective dose was 0.051 mSv/MBq. 68Ga-DOTA-Bombesin 
was well tolerated by all subjects. The authors concluded that the intravenously 
injected 68Ga-DOTA-Bombesin is safe, and rapid metabolism is demonstrated. A 
140-MBq injection of 68Ga-DOTA-Bombesin results in an effective dose of 4.76 
mSv after voiding at 1 hour.. 
 
Measured human dosimetry data are available from published data (30) and presented 
below. 
 
The 68Ga radioactivity was rapidly excreted through the kidneys to the urinary 
bladder and accumulated predominantly in the pancreas and liver. Maximum peak 
uptake of the total injected radioactivity was seen in the urinary bladder contents and 
the liver, with approximately 36% and 14%, respectively. 
 
The mean normalized number of disintegrations in units of hours of the source organs 
and remainder of the body are listed in Table 1. The largest mean normalized number 
of disintegrations for the subjects was found in the remainder tissues (0.67 h), urinary 
bladder contents (0.53 h), and pancreas (0.11 h). 
Organ Mean SD Minimum Maximum 
Heart contents 0.038 0.0052 0.029 0.043 
Kidneys 0.050 0.0071 0.041 0.060 
Liver 0.074 0.014 0.055 0.093 
Pancreas 0.11 0.035 0.067 0.15 
Red marrow 0.087 0.030 0.066 0.11 
Salivary 0.0033 0.0013 0.0011 0.0044 
Spleen 0.0065 0.0014 0.0040 0.0073 
Stomach wall 0.012 0.0030 0.0079 0.014 
Thyroid 0.0012 0.00054 0.0057 0.0018 
Urinary bladder 0.53 0.050 0.47 0.59 
Remainder of body 0.67 0.071 0.59 0.75 
Table 1: Normalized number of disintegrations (hours) of source organs after 
injection 68Ga-DOTA-Bombesin. 
 
The estimations of the absorbed doses are reported in Table 2. The organ with the 
highest absorbed dose was the urinary bladder wall at 0.61 mSv/MBq, followed by 
the pancreas at 0.51 mSv/MBq. The mean effective dose (14) was 0.051 mSv/MBq. 
Thus, the effective dose from a 150-MBq injected radioactivity is 7.7 mSv, which 
could be reduced to roughly 5.7 mSv with frequent bladder voiding (1-h voids). 
Organ Mean SD Minimum Maximum 

January 12, 2021 
 
Page 6 of 13 
Adrenals 0.011 0.00080 0.010 0.012 
Brain 0.0056 0.00051 0.0049 0.0061 
Breasts 0.0060 0.00048 0.0053 0.0064 
Gallbladder wall 0.011 0.00054 0.0099 0.011 
Lower large intestine wall 0.014 0.00036 0.013 0.014 
Small intestine 0.010 0.00032 0.0096 0.010 
Stomach wall 0.038 0.0090 0.027 0.045 
Upper large intestine wall 0.0094 0.00037 0.0089 0.0098 
Heart wall 0.028 0.0030 0.023 0.031 
Kidneys 0.081 0.011 0.067 0.096 
Liver 0.023 0.0035 0.019 0.028 
Lungs 0.0071 0.00048 0.0064 0.0076 
Muscle 0.0082 0.00038 0.0077 0.0086 
Pancreas 0.51 0.16 0.32 0.73 
Red marrow 0.013 0.0087 0.0068 0.026 
Osteogenic cells 0.013 0.0051 0.0092 0.021 
Salivary glands 0.022 0.0022 0.020 0.026 
Skin 0.0060 0.00044 0.0055 0.0065 
Spleen 0.023 0.0036 0.017 0.026 
Testes 0.010 0.00045 0.0097 0.011 
Thymus 0.0070 0.00055 0.0064 0.0076 
Thyroid 0.027 0.011 0.014 0.039 
Urinary bladder wall 0.61 0.057 0.54 0.68 
Total body 0.010 0.00031 0.0098 0.011 
Effective dose 0.051 0.0072 0.044 0.063 
Table 2: Dose Equivalent estimates (mSv/MBq) after injection of 68Ga-DOTA-
Bombesin 
 
To summarize the results of the published human dosimetry study, there were no 
observed adverse events to the radiopharmaceutical. The measured dosimetry showed 
that the critical organ with 68Ga-DOTA-Bombesin is the urinary bladder, followed 
by the pancreas. The effective dose of 68Ga-DOTA-Bombesin reported (0.051 
mSv/MBq) is approximately twice as much as that of 68Ga-DOTA-TOC (0.023 
mSv/MBq), 68Ga-DOTA-NOC (0.025 mSv/MBq), 68Ga-DOTA-TATE (0.021 
mSv/MBq) and 68Ga-NOTA-RGD (0.022 mSv/MBq) 
c. 
Radiation Machines – Diagnostic Procedures 
i. 
Examination description (well-established procedures) 
Immediately after completion of the standard PET/CT the subject will undergo a 
study scan using the Discovery PET/CT system. Similarly, if Discovery PET/CT will 
be used first, scan will be acquired immediately after using standard PET/CT. 
 
Collection of the study PET/CT imaging data shall be completed up to 1 hour after 
completion of the standard PET/CT scan. First a CT will be done for attenuation 
correction. This will be followed by emission PET scan over the same regions. 
ii. 
Total number of times each procedure will be performed (typical study participant) 

January 12, 2021 
 
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Once. 
iii. 
Setup and techniques to support dose modeling 
First PET/CT: CT as ordered by referring physician, followed by emission PET 
Second PET/CT: CT for attenuation correction, followed by emission PET 
iv. 
FDA status of the machine and information on dose modeling (if procedure is not 
well-established) 
   
The digital PET/CT is now FDA-approved 
d. 
Radiation Machines – Therapeutic Procedures 
i. 
Area treated, dose per fraction/number of fractions, performed as part of normal 
clinical management or due to research participation (well-established procedures) 
N/A 
ii. 
FDA status of the machine, basis for dosimetry, area treated, dose per fraction and 
number of fractions (if procedure is not well-established) 
N/A 
5. 
DEVICES USED IN THE STUDY 
a. 
IDE-Exempt Devices 
IND-Exempt Device 1 
Name: 
Discovery MI 
Description: 
Digital PET/CT scanner, that is FDA approved.  
 
6. 
DRUGS, BIOLOGICS, REAGENTS, OR CHEMICALS USED IN THE STUDY 
a. 
Investigational Drugs, Biologics, Reagents, or Chemicals 
Investigational Product 1 
Name: 
Ga-68 PSMA 
Dosage: 
3-5 mCi 
Administration Route: 
i.v. 
Investigational Product 2 
Name: 
Ga-68 RM2 
Dosage: 
140 MBq 
Administration Route: 
i.v. 
b. 
Commercial Drugs, Biologics, Reagents, or Chemicals 
Commercial Product 1 
Name: 
F-18 FDG 
Dosage: 
10-12 mCi 
Administration Route 
i.v. 
New and different use? (Y/N) 
No 
Commercial Product 2 
Name: 
F-18 NaF 
Dosage: 
5-10 mCi 
Administration Route 
i.v. 

January 12, 2021 
 
Page 8 of 13 
New and different use? (Y/N) 
No 
Commercial Product 3 
Name: 
Ga-68 DOTA TATE 
Dosage: 
5-7 mCi 
Administration Route 
i.v. 
New and different use? (Y/N) 
No 
7. 
DISINFECTION PROCEDURES FOR MEDICAL EQUIPMENT USED ON BOTH HUMANS AND 
ANIMALS 
N/A 
 
8. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
300 adult participants will be enrolled at Stanford. Participants will be clinical patients 
who are scheduled for a standard of care or research PET/CT. 
b. 
Age, Gender, and Ethnic Background 
All age ranges of adult population (> 18-years old) will be recruited. Both men and 
women will be recruited. All ethnic background will be recruited. No healthy volunteers 
will be recruited. Pregnant women will be excluded because pregnancy is a 
contraindication for a PET/CT study. 
c. 
Vulnerable Populations 
No potentially vulnerable patients will be entered into this study. 
d. 
Rationale for Exclusion of Certain Populations 
We are not excluding any minorities; we are not excluding women due to their gender, 
only if they are pregnant or breastfeeding, to protect the fetus or baby.  
e. 
Stanford Populations 
No laboratory personnel, employees, and/or students will be recruited for this protocol.  
f. 
Healthy Volunteers 
No healthy volunteers will be included into this study. 
g. 
Recruitment Details 
Potential participants will be identified from the PET/CT schedule in Nuclear Medicine 
(patients referred for standard or research PET/CT). Therefore a Waiver of Authorization 
for Recruitment will be applied for in the relevant section. 
 
3 days+ in advance of scan, fellows/coordinators would identify patients that qualify 
based on data in the medical record. 
2 days in advance, technologist or Nuc Med physician call patients to prep patients for 
the scan and ask whether a fellow/coordinator can contact them about the study. 

January 12, 2021 
 
Page 9 of 13 
1 day in advance, if they agree to be contacted, a fellow or coordinator would discuss the 
study with them. 
Day of the scan, if they are still a candidate, fellow/coordinator will discuss further with 
them, answer questions, and sign informed consent. 
h. 
Eligibility Criteria 
i. 
Inclusion Criteria 
• Patient is ≥ 18 years old at the time of the scan 
• Patient provides written informed consent 
• Patient is referred for standard or research (68Ga PSMA or 68Ga RM2) PET/CT 
• Patient is capable of complying with study procedures 
• Patient is able to remain still for duration of imaging procedure (approximately 60 
minutes total for both PET/CT) 
ii. 
Exclusion Criteria 
• Patient is < 18 years old at the time of the drug administration 
• Patient is pregnant or nursing 
i. 
Screening Procedures 
Patients will be identified from the PET/CT schedule in Nuclear Medicine. Therefore a 
Waiver of Authorization for Recruitment will be obtained in the relevant section. 
j. 
Participation in Multiple Protocols 
As part of the consent form process the patient will be asked if they are participating in a 
concurrent research protocol. Those enrolled in the Ga68 PSMA or Ga58 RM2 protocols 
will be allowed to participate.  
k. 
Payments to Participants 
Patients will be paid $
 for participation in this study. 
The second PET/CT will add up to 60 minutes to the patients' scheduled PET/CT visit. 
Given the construction delays and parking situation at Stanford, the investigators felt that 
the participants need to be compensated for their time and effort. We consider $
 an 
appropriate amount given the above reasons, in line with other studies and not undue 
pressure on participants 
l. 
Costs to Participants 
There will be no costs for participating in this study. 
m. 
Planned Duration of the Study 
The screening part of the study will involve a phone call. This will take approximately 15 
minutes. The first PET/CT will take up to 90 minutes of the subjects time. This includes 1 
hour tracer uptake time and the 30 minutes scan. The second scan will take up to another 
60 minutes. (iii) Analysis of the participant data may take up to 6 months. 
9. 
RISKS 

January 12, 2021 
 
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a. 
Potential Risks 
i. 
Investigational devices 
N/A 
ii. 
Investigational drugs 
This research study involves exposure to radiation. 
 
The effective dose from one typical 140 MBq administration of 68Ga-PSMA is 4.36 
mSv, approximately equal to 10% of the limit that radiation workers (for example, a 
hospital x-ray technician) are allowed to receive in one year. 
 
The amount of radiation from one 68Ga-RM2 PET is 4.76 mSv, approximately equal to 
10% of the limit that radiation workers (for example, a hospital x-ray technician) are 
allowed to receive in one year. 
 
This amount of radiation involves minimal risk and is necessary to obtain the research 
information desired. This is captured in the ICF for the PSMA and RM2 protocols. 
iii. 
Commercially available drugs, biologics, reagents or chemicals 
The administration of the radioactive substance will feel like a slight pinprick when given 
by intravenous injection. 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. 
iv. 
Procedures 
No procedures will be performed. 
v. 
Radioisotopes/radiation-producing machines 
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. 
 
This research study involves exposure to radiation from one additional CT for attenuation 
correction in the digital PET/CT. This radiation exposure is not necessary for your 
medical care and is for research purposes only. The additional amount of radiation 
exposure is about 3 mSv, which is approximately equal to 6% of the limit workers 
exposed to radiation are allowed to receive in one year. This amount of radiation involves 
minimal risk and is necessary to obtain the research information desired. 
vi. 
Physical well-being 
Low risk. 
vii. 
Psychological well-being 
Low risk. 

January 12, 2021 
 
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viii. 
Economic well-being 
Low risk. 
ix. 
Social well-being 
Low risk. 
x. 
Overall evaluation of risk 
Low risk.  
b. 
International Research Risk Procedures 
N/A 
c. 
Procedures to Minimize Risk 
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 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. 
 
The studies will be performed in a medical setting, under researchers' supervision. Crash 
cabinets will be available for emergencies. 
 
All computers, external hard disks, USB thumbs, tablet computer, smart phone - any 
electronic devices that contain identifiable subject data - are encrypted in addition to 
password protected. 
d. 
Study Conclusion 
The experiment will terminate when all subjects will have the scans done. 
 
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. 
The studies will be performed in a medical setting, under researchers' supervision. Crash 
cabinets will be available for emergencies. 
e. 
Data Safety Monitoring Plan (DSMC) 
i. 
Data and/or events subject to review 
Informed consent was properly obtained, any required pre-study tests and procedures 
were obtained within the designated pre-treatment time interval, Eligibility criteria 
were accurately met, Appropriate and timely reporting of adverse events (AEs) and 

January 12, 2021 
 
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serious adverse events (SAEs) to the IRB, Adherence to subject follow-up 
requirements. 
ii. 
Person(s) responsible for Data and Safety Monitoring 
GE is the monitoring entity because GE is the Study Sponsor. The monitoring visits 
will be conducted by a GE Clinical Research Associate (CRA). 
iii. 
Qualifications of person(s) responsible for Data and Safety Monitoring 
The GE Clinical Research Associate (CRA) has extensive experience in overseeing 
such trials. 
iv. 
Safety Reporting 
PD must notify the Sponsor and FDA of any study-related death or life-threatening 
event via telephone or email within 24 hours of learning of the event, 
The GE Clinical Research Associate (CRA) will determine frequency of visits and 
meetings depending on accrual.  
 
Data and safety monitoring activities and continuing study reviews take place until 
all subjects have been accrued. 
v. 
Specific triggers or stopping rules 
vi. 
Studies that received a rating less than satisfactory during the initial auditing review a 
re reviewed again by the ME on a case-by-case basis. Any follow-up 
recommendations such as a corrective action plan or re-auditing are based upon the 
results of the auditing review. For example, additional patient eligibility monitoring 
is performed if one or more of the patients were found to be ineligible. Findings such 
as the type and degree of protocol deviations or violations, unreported serious 
adverse events, and investigational drug medication errors may also warrant further 
review. A corrective action plan requires a prompt response by the PI. Once the ME 
determines that the corrective action plan is adequate to ensure subject safety, re-
auditing is determined by the rate of subject accrual.DSMB Reporting 
Internal Reporting 
When the GE Clinical Research Associate (CRA) recommends suspension or study 
closure, they will notify principal investigators, study coordinators, and other 
organizations such as the IRB, as appropriate. 
 
Confidentiality Procedures 
Industry studies are considered proprietary to the sponsor. Any outcome results are 
strictly confidential and must not be divulged to anyone who is not a member of the 
sponsor monitoring entity except as specified above. The sponsor monitoring entity 
maintains the integrity of the data and records by keeping all source documentation in 
a secure locked office. 
vii. 
Will the Protocol Director be the only monitoring entity? (Y/N) 
No 

January 12, 2021 
 
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viii. 
Will a board, committee, or safety monitor be responsible for study monitoring? 
(Y/N) 
No 
f. 
Risks to Special Populations 
N/A 
10. 
BENEFITS 
Understanding the imaging characteristics of the digital PET/CT scanner can 
potentially improve the patient care, improving the image quality, by scanning the 
patients most suitable for the individual scanner. 
11. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.