Conditions: Prostate Adenocarcinoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 122
Healthy volunteers: no

Brief summary:
Prostate cancer (PC) remains the most-common non-cutaneous cancer diagnosed in American males, accounting for an estimated 174,560 estimated new cases and 31,620 estimated deaths in 2019. Up to 40% of the patients with prostate cancer develop biochemical recurrence within 10 years after initial treatment. Usually an increase of the prostate-specific antigen (PSA) llevel precedes a clinically detectable recurrence by months to years, and this is currently used as a screening test before and subsequent to treatment. However, disease advancement can be local, regional or systemic, and each has significantly different approaches to disease management. Unfortunately, PSA level does not differentiate between these disease stages.

This phase 2-3 study explores the utility of radiolabel 68Ga-RM2, a 68-gallium (68Ga)-labeled gastrin-releasing peptide receptor (GRPr) antagonist, for positron emission tomography (PET) / magnetic resonance imaging (MRI) (collectively, PET/MRI) as a potential tool to help discriminate between disease stages in participants after treatment with surgery or radiation, who present persistently elevated PSA levels (ie, may have prostate cancer), but were negative for cancer with a diagnostic regular medical care computed tomography (CT) scan

68Ga-RM2 (BAY86-7548) is also identified as a synthetic bombesin receptor antagonist. PET/MRI is the collective result of 2 scan processes (PET and MRI ) conducted during the same scan procedure (ie, a combined scan). After a regular medical care computed tomography (CT) scan, participants will be scanned with 68Ga-RM2 PET/MRI scan procedure. PET/MRI is used to assess the location, size, and metabolic activity of a suspected tumor.

The 68Ga-RM2 radiolabel consisted of a ligand (the synthetic bombesin receptor antagonist) and the radioisotope 68Ga. The RM2 ligand targets gastrin-releasing peptide receptors (GRPr), commonly expressed by prostate cancer cells, and the radioisotope distinguishes those cells from the background. The criteria for scan "positivity" will be, when compared to background level of the liver (control), the 68Ga signal is stronger (positive - malignant) or weaker (negative - benign).

This study will assess how well 68Ga-RM2 works in detecting prostate cancer in patients with

68Ga-RM2 PET/MRI may be able to see smaller tumors than the standard of care contrast-enhanced CT or MRI scan.

Detailed description:
PRIMARY OBJECTIVES:

Evaluate 68Ga-RM2 as the radiolabel for PET/MRI scans used for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (PSA) and non-contributory computed tomography (CT).

OUTLINE:

Patients receive 68Ga-RM2 intravenously (IV) and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician.

After completion of study, patients are followed up at 24 to 48 hours and then at 1 year.

Arms:
arm 1: Patients receive 68Ga-RM2 IV and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician. Imaging with PET/MRI is the intervention.

Interventions: intervention 1: 68Ga-RM2 intervention 2: Magnetic Resonance Imaging intervention 3: Positron Emission Tomography
Intervention descriptions: intervention 1: Imaging with PET/MRI intervention 2: Imaging with 68Ga-RM2 PET/MRI intervention 3: Imaging with 68Ga-RM2 PET/MRI

Protocol document:
Prot_SAP_000.pdf: 
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CONFIDENTIAL 
30 April 2019 
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
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: 
Bruce Daniel, MD, PhD 
300 Pasteur Dr H1307 MC 5621  
Stanford, CA 94305  
Phone: 650-725-1812 
Email: bdaniel@stanford.edu  
Steven Hancock, MD 
875 Blake Wilbur Dr, Clinic D  
Stanford, CA 94305  
Phone: 650-723-6171 
Email: shancock@stanford.edu  
Andreas Loening, MD, PhD 
300 Pasteur Dr, H1307 MC 5105  
Stanford, CA 94305  
Phone: 650-723-7816 
Email: loaning@stanford.edu  
Guido Davidzon, MD 
300 Pasteur Drive, Room H-2230 
Stanford, CA 94305 
Phone: 650-725-4711 
Email: gdavidzon@stanford.edu  
Geoffrey Sonn, MD 
875 Blake Wilbur Dr, Clinic E  
Stanford, CA 94305 
Phone: 650-725-5544 
Email: gsonn@stanford.edu  
Sandy Srinivas, MD 
875 Blake Wilbur Dr, Clinic E  
Stanford, CA 94305 
Phone: 650-724-8372 
Email: sandysri@stanford.edu  
Shreyas Vasanawala, MD, PhD 
725 Welch Rd, St 1679 MC 5913  
Palo Alto, CA94304 
Phone: 650-724-9824 
Email: vasanawala@stanford.edu 
 
Biostatistician 
Jarrett Rosenberg, PhD 
1201 Welch Road, Room P-280 
Stanford, CA 94305 
Phone: 650-724-3289 
Email: Jarrett.rosenberg@stanford.edu  
Study Coordinator 
Jordan Cisneros, BS 
800 Welch Road 
Phone: 650-725-6409 
Email: jordan.cisneros@stanford.edu  
Protocol IRB-35155  //   PROS0074  //  NCT02624518  
Protocol Version 13/ Version Date: 30 April 2019  


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TABLE OF CONTENTS 
PROTOCOL SYNOPSIS ............................................................................................................ 3 
SCHEMA .................................................................................................................................... 4 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ....................................................... 4 
1. OBJECTIVES ...................................................................................................................... 5 
2. BACKGROUND ................................................................................................................... 5 
2.1 Preliminary information .............................................................................................. 5 
2.2 Study Agent ................................................................................................................. 7 
2.3 Clinicaltrials.gov ......................................................................................................... 7 
2.4 Rationale ...................................................................................................................... 7 
2.5 Study Design ............................................................................................................... 9 
3. PARTICIPANT SELECTION AND ENROLLMENT PROCEDURES .................................... 9 
3.1 Inclusion Criteria ......................................................................................................... 9 
3.2 Exclusion Criteria...................................................................................................... 10 
3.3 Informed Consent Process ....................................................................................... 10 
3.4 Study Timeline .......................................................................................................... 10 
4. IMAGING AGENT INFORMATION .................................................................................... 10 
4.1 Study Agent ............................................................................................................... 10 
4.2 Specify the source of the study agent. .................................................................... 12 
4.3 Describe how the agent will be requested and provide mailing address and phone 
number. ........................................................................................................................... 12 
4.4 Agent Accountability ................................................................................................ 12 
5. IMAGING SPECIFICS ....................................................................................................... 12 
5.1 
Modality or Modalities to be used ......................................................................... 12 
5.2 
Details of Imaging (i.e. dynamic, static, number of scans, etc.) ......................... 12 
5.3 
Details of processing/analysis .............................................................................. 13 
6. STUDY PROCEDURES .................................................................................................... 13 
6.1 
Criteria for Removal from Study ........................................................................... 13 
6.2 
Alternatives ............................................................................................................ 13 
7. STUDY CALENDAR .......................................................................................................... 13 
8. ADVERSE EVENTS AND REPORTING PROCEDURES .................................................. 13 
8.1 Potential Adverse Events ......................................................................................... 13 
8.2 Adverse Event Reporting ......................................................................................... 14 
9. REGULATORY CONSIDERATIONS ................................................................................. 14 
9.1 Institutional Review of Protocol ............................................................................... 14 
9.2 Data Management Plan ............................................................................................. 14 
10. 
MEASUREMENTS .................................................................................................... 15 
10.1 Primary outcome measure ..................................................................................... 15 
10.2 Measurement Methods ........................................................................................... 15 
10.3 Measurement Time Points ...................................................................................... 15 
11. 
STATISTICAL CONSIDERATIONS ........................................................................... 15 
11.1  Statistical Design ................................................................................................... 15 
11.2  Randomization ....................................................................................................... 15 
11.3  Interim analyses ..................................................................................................... 15 
11.4  Key variables .......................................................................................................... 15 
11.5  Sample Size ............................................................................................................ 15 
11.6  Accrual estimates .................................................................................................. 16 
APPENDIX:  Inclusion/Exclusion Criteria Checklist ........................................................... 16 
REFERENCES: ................................................................................................................ 17 
 


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PROTOCOL SYNOPSIS 
 
TITLE 
68Ga-RM2 PET/MRI in Patients with Biochemically 
Recurrent Prostate Cancer and Non-Contributory 
Conventional Imaging 
STUDY PHASE 
Phase 2-3 
INDICATION 
Prostate cancer 
INVESTIGATIONAL PRODUCT OR 
PROCEDURE 
68Ga-RM2 
PRIMARY OBJECTIVE(S) 
To evaluate 68Ga-RM2 (formerly known as 
68Ga Bombesin or BAY 86-7548) PET/MRI for 
detection of recurrent prostate cancer after initial 
therapy in patients with elevated PSA and 
non-contributory computed tomography (CT). 
SAMPLE SIZE  
125 participants 
STATISTICAL CONSIDERATIONS 
Prospective single center, single-arm study.  
HYPOTHESES 
1. At least 30% of patients will have one or more 
lesions detected on PET/MR. 
2. PET/MR sensitivity will be higher than MR alone. 
STATISTICAL TEST 
McNemar tests of paired proportions for sensitivity 
and specificity. 
STATISTICAL POWER AND SAMPLE SIZE 
We expect that roughly 50% of patients will have 
lesions (as determined by biopsy or follow-up).  
Assuming a difference in sensitivity for PET/MRI 
and MRI of 20 percentage points (eg, 70% vs 50%), 
a sample of 60 diseased patients will provide 90% 
power at 5% error to detect such a difference.  
Assuming a difference in specificity for PET/MRI 
and MRI of 20 percentage points (eg, 70% vs 90%), 
a sample of 60 non-diseased patients will provide 
98% power at 5% error to detect such a difference. 
 
 


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SCHEMA 
 
 
 
 
 
 
 
 
 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
 
Ga-68 
Gallium-68 
IRB 
Institutional Review Board 
IV 
Intravenous 
PET/MRI 
Positron emission tomography – magnetic resonance imaging 
SUV 
Standardized Uptake Value 
GRPr 
Gastrin releasing peptide receptor 
Eligible participant with prostate cancer 
68Ga-RM2 PET/MRI 


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1. OBJECTIVE 
Specific Aim 
To evaluate 68Ga-RM2 (formerly known as DOTA Bombesin or BAY 86-7548) PET/MRI for 
detection of recurrent prostate cancer after initial therapy in patients with elevated PSA and 
non-contributory computed tomography (CT). 
2. BACKGROUND 
2.1 Preliminary information 
Prostate cancer (PC) remains the most-common non-cutaneous cancer diagnosed in American 
males, accounting for an estimated 174,560 estimated new cases and 31,620 estimated deaths in 
2019 (1).   Subsequent treatment is multifaceted and may involve observation, surgery 
(prostatectomy), radiation therapy (external beam or brachytherapy), hormonal therapy, 
chemotherapy, or a combination of these (2-4).  
Up to 40% of the patients with prostate cancer develop biochemical recurrence within 10 years 
after initial treatment (5).  Usually an increase of the PSA-level precedes a clinically detectable 
recurrence by months to years (6).  However, it cannot differentiate between local, regional or 
systemic disease with the necessary precision that is essential for further disease management 
(7).  
Morphological imaging methods exhibit considerable limitations:  sensitivity ranges between 25% 
and 54% for the detection of local recurrence by transrectal ultrasound (TRUS) or 
contrast-enhanced CT and is moderately improved by using functional MRI techniques (7-9).  The 
sensitivity for detection of lymph node metastases of CT or MRI is reported to be 30 to 80% (10). 
Ultra-small particles of iron oxides (USPIOs) proved to be very effective, but are yet to be 
approved by regulatory authorities (11).  Bone metastases presenting as osteoblastic lesions can 
be effectively detected by bone scintigraphy, PET, CT and MRI (12,13). 
Various targets have been addressed by molecular imaging to improve the detection of recurrent 
prostate cancer. PET tracers such as 18F- or 11C-labeled choline and 11C-acetate have been 
investigated for the diagnosis of recurrent (14-16) prostate cancer.  Their feasibility in primary 
diagnosis is limited because of uptake in benign tissue such as benign prostatic hyperplasia or 
inflammatory lymph nodes (17,18).  In addition, fluorinated versions are not available in the United 
States, while 11C-labeled tracers cannot be widely used due to the requirement for an on-site 
cyclotron due to the short half-life.  18F-FACBC, a new synthetic amino acid, might be superior 
when compared to 11C-choline PET/CT (19).  owever, recent work indicates that 18F-FACBC 
uptake in prostate cancer is similar to that in BPH nodules (20). Prostate-specific membrane 
antigen (PSMA) continues to elicit high interest.  This cell surface protein is significantly 
overexpressed in prostate cancer cells when compared to other PSMA-expressing tissues such as 
kidney, proximal small intestine or salivary glands.  It therefore provides a promising target for 
prostate cancer-specific imaging.  
Recently methods have been developed to label PSMA ligands with 68Ga and 18F. Initial 
experience suggests that these novel tracers can detect prostate cancer relapses and metastases 
with high contrast by binding to the extracellular domain of PSMA, followed by internalization 
(21,22). However, these promising agents do not detect all recurrences.  
Consequently, improved imaging of biochemically recurrent prostate cancer continues to be an 
area of unmet clinical need.  68Ga-labeled DOTA-4-amino-1-carboxymethyl-piperidine-D-Phe-Gln-
Trp-Ala-Val-Gly-His-Sta-Leu-NH2 (68Ga-DOTA-Bombesin or 68Ga-RM2, formerly also known as 
BAY86-7548) is a synthetic bombesin receptor antagonist, which targets gastrin-releasing peptide 


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receptors (GRPr) (23).  GRPr proteins are highly overexpressed in several human tumors, 
including prostate cancer (24).  Because of their low expression in BPH and inflammatory prostatic 
tissues (25,26), imaging of GRPr has potential advantages over current choline- and 
acetate-based radiotracers.  Indeed, preclinical studies using BAY86-7548 have shown a high and 
persistent tracer uptake in mice bearing PC-3 tumor xenografts, which represent 
androgen-independent human prostate cancer with high GRPr expression (27). 
We conducted a pilot phase evaluation of 68Ga-RM2 under an RDRC-approved protocol at 
Stanford University.  Ten men (age range:  60 to 83 year-old;  mean ± SD: 73.1 ± 6.9) with 
biochemical recurrence of prostate cancer (PSA range:  3.7 to 36.4; mean ± SD: 12.5 ± 9.8) were 
enrolled.  PET/MRI images were acquired at 42-51 minutes (mean ± SD:  47.2 ± 3.2) after 
injection of 3.6 to 4.1 mCi (mean ± SD:  3.7 ± 0.2) of 68Ga-RM2.  The uptake of 68Ga-RM2 was 
identified as described in previously published studies referenced above. All participants had 
multiple standard of care imaging studies (CT, MRI, 18F FDG PET/CT, 18F-NaF PET/CT, 99mTc 
MDP bone scan) prior to enrollment that were non-contributory, despite rising PSA values.  The 
time from conventional imaging to enrollment in the protocol ranged 10 to 107 days (mean ± SD:  
43.3 ± 26.0).  One participant also had 11C Acetate and 11C-Choline at other institutions in the 
setting of rising PSA (2.72 ng/mL and 3.63 ng/mL, respectively).  Both scans were negative for 
recurrent prostate cancer lesions.  The participants did not receive treatment in this interval as 
they were managed under a wait and watch strategy due to no identifiable disease.  The interval 
from biochemical recurrence to the 68Ga-RM2 PET/MRI scan ranged 5 to 75 months (mean ± SD:  
30.8 ± 20.4). This pilot data (28) also showed distinct biodistribution and lesion localization 
between 68Ga-RM2 and 68Ga-PSMA11 due to non-overlapping underlying biology. 
Biodistribution and localization of 68Ga-RM2 
All participants tolerated the procedure without immediate or delayed (up to 7 days) complaints or 
complications.  Table 2 shows the 68Ga-RM2 uptake (SUVmax and SUVmean) in normal tissues.  The 
areas with the highest 68Ga-RM2 accumulation are the pancreas (mean SUVmax:  52.0 ± 16.7 
[range:  36.8 to 93.8] and SUVmean:  33.2 ± 17.5 [range:  8.8 to 66.1]) and bladder (mean SUVmax:  
121.6 ± 67.5 [range:  32.6 to 220.7] and SUVmean:  93.8 ± 59.7 [range:  29.8 to 195.7]), while 
moderate uptake was noted in the blood pool (mean SUVmax:  2.3 ± 0.7 [range:  1.8 to 4.0] and 
SUVmean:  1.3 ± 0.7 [range:  0.7 to 2.7]), stomach (mean SUVmax:  2.5 ± 0.7 [range:  1.3 to 3.7] and 
SUVmean:  1.3 ± 0.5 [range:  0.6 to 1.9]), small bowel  (mean SUVmax:  2.4 ± 0.6 [range:  1.7 to 3.3] 
and SUVmean:  1.4 ± 0.5 [range:  0.7 to 2.3])and colon (mean SUVmax:  2.0 ± 0.7 [range:  1.3 to 3.8] 
and SUVmean:  1.0 ± 0.6 [range:  0.5 to 2.3]). The liver had low 68Ga-RM2 uptake with SUVmean of 
less than 1.0. There were no differences between the 68Ga-RM2 biodistribution at 45 minutes 
post-injection among the 10 participants (Figure 1). The pattern of 68Ga-RM2 uptake is similar to 
previous reports (29,30). 
68Ga-RM2 uptake outside the expected physiologic biodistribution 
One case had no focal 68Ga-RM2 uptake outside the expected physiologic biodistribution. The 
remaining 9 participants had 28 areas of high 68Ga-RM2 uptake (up to 10 areas were recorded per 
participant) that corresponded to retroperitoneal lymph nodes (n = 10), bone marrow (n = 7), 
mediastinal lymph nodes (n = 3), pelvic lymph nodes (n = 2), seminal vesicle (n = 2), subclavian 
lymph node (n = 1), mesenteric lymph node (n = 1) and prostate bed (n = 1) on the MRI images. 
These areas of high 68Ga-RM2 uptake had SUVmax of 13.4 ± 8.3 (range:  2.6 to 33.5) and SUVmean 
of 6.7 ± 3.9 (range:  1.7 to 16.1), above the background and easily identifiable given the lack of 
hepato-biliary clearance.  


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Figure 1: Maximum intensity projection (MIP) images from 5 participants in the pilot study conducted at 
Stanford University. Arrows mark suspected recurrent prostate cancer; high uptake in the pancreas is due to 
known over-expression of GRPr. 
The mean diameter of lymph nodes with high 68Ga-RM2 uptake was 1.3 ± 0.8 cm (range: 
0.4 to 2.9 cm).  PSA was 6.7 ng/mL in the patient with no focal 68Ga-RM2 uptake outside the 
expected physiologic biodistribution and ranged 3.7 to 36.4 (mean ± SD: 13.1 ± 10.2) for the other 
patients.  
We recently published our results using 68Ga-RM2 PET/MRI in 32 patients with biochemical 
recurrence of PC and negative conventional imaging (bone scintigraphy and CT or MRI) (31). 
These participants will not be evaluated in the current analysis. 
2.2 Study Agent 
We will use 68Ga-RM2, formerly also known as 68Ga-DOTA Bombesin or BAY86-7548 as the PET 
radiopharmaceutical. This is not an FDA-approved product, but we have a FDA-approved IND 
(127137) allowing the use of this tracer in this proposed clinical indication. 
2.3 Clinicaltrials.gov  
This study will be registered on ClinicalTrials.gov. 
2.4 Rationale 
In this study, we propose to use a well-established PET isotope, Gallium-68 (68Ga), bound to a 
bombesin receptor antagonist, 68Ga-RM2, which has high affinity for gastrin-releasing peptide 


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receptors. GRPr proteins are highly overexpressed in several human tumors, including prostate 
cancer (24). Because of their low expression in BPH and inflammatory prostatic tissues (25,26), 
imaging of GRPr has the potential to improve the lesion detection in prostate cancer. Therefore, 
we propose the following aim: 
 
To evaluate 68Ga-RM2 (68Ga-DOTA-Bombesin) PET/MRI for detection of recurrent prostate 
cancer after initial therapy in patients with elevated PSA (> 2 ng/mL) and non-contributory 
computed tomography (CT). 
 
Figure 2. Chemical structure of 68Ga-DOTA-Bombesin 
 
The first-in-human study investigated the safety, tolerability, metabolism, pharmacokinetics, 
biodistribution, and radiation dosimetry of 68Ga-RM2.  Five healthy men underwent dynamic 
whole-body PET/CT after an intravenous injection of 68Ga-RM2 (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-RM2 was well 
tolerated by all subjects.  The authors concluded that the intravenously injected 68Ga-RM2 is safe, 
and rapid metabolism is demonstrated.  A 150-MBq injection of 68Ga-RM2 results in an effective 
dose of 7.7 mSv, which could be reduced to 5.7 mSv with frequent bladder voids (29).  
 
Figure 3: Coronal (A) and axial views (B and C) of 68Ga-RM2 PET/CT in patient no. 8 with prostate cancer 
metastasis to multiple lymph nodes. Two normal-sized (less than 10 mm) nodes above the aortic bifurcation 
indicated with red arrow showed increased uptake of tracer, SUVmax 6.2 and 6.3. In addition, one left 
parailiac node, SUVmax 12.7, (B) and two right parailiac nodes, SUVmax 6.1 and 4.7, (C) showed 


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increased uptake of 68Ga-RM2. These five lymph nodes were histologically confirmed as metastases at 
surgery. Green arrows point to ureters, which can be easily distinguished on anatomic CT. 
 
In the first study with 68Ga-RM2 in patients with prostate cancer, 14 men scheduled for radical 
prostatectomy (n = 11) or with biochemical recurrence after surgery or hormonal therapy (n = 3) 
were enrolled.  The patients received an intravenous injection of 68Ga-RM2 followed by over 
60-minute dynamic imaging of prostate gland (n = 10) and/or subsequent whole-body imaging 
(n = 14).  The visual assessment of PET/CT images included evaluation of intraprostatic (12 
subsextants) and pelvic nodal uptake of 68Ga-RM2 in 11 surgical patients and detection of 
potential metastatic foci in all patients.  In patients with biochemical recurrence, results were 
compared with those of either 11C-acetate (n = 2) or 18F-fluoromethylcholine (n = 1) PET/CT.  The 
authors reported a sensitivity, specificity, and accuracy of 88%, 81% and 83%, respectively, for 
detection of primary prostate cancer and sensitivity of 70% for metastatic lymph nodes using 
histology as gold standard (30). 
2.5 Study Design 
This is a prospective, single center, single-arm study enrolling 125 participants with prostate 
cancer.  Eligible participants will undergo baseline assessments at enrollment.  Study participants 
will receive 68Ga-RM2 and undergo a PET/MRI scan.  All patients will first be seen by a Stanford 
Cancer Institute physician and then referred if appropriate on clinical grounds to Dr. Iagaru or his 
colleagues for this study.  The following steps will take place. 
1. Participant will be asked to drink 1 to 2 glasses of water before arrival at the clinic 
2. Participants will be weighed and vital signs (heart rate, blood pressure, respiratory rate, pulse 
oxymetry) will be recorded 
3. Participant will be injected i.v. with 140 MBq of 68Ga-RM2 
4. Participant will void immediately prior to the scan 
5. Approximately 45 minutes after the radiopharmaceutical i.v. administration, data acquisition 
will begin in the pelvic region and move toward the head.  First, localizer MRI scans will be 
performed to define the table positions.  After correct positioning of the spatial acquisition 
windows is ensured, the combined PET/MRI acquisition will be initiated with 3–5 table 
positions at a 4-min acquisition time per table position. 
6. Participants will be given a copy of the consent form s/he signed and will be dismissed. 
7. Vital signs (heart rate, blood pressure, respiratory rate, pulse oxymetry) will be recorded again 
at the completion of the study. 
8. Participants will be contacted at 24 to 48 hours following the scan in order to capture potential 
late occurring Adverse Events. 
The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to 
therapy, if requested by the treating physician.  
3. PARTICIPANT SELECTION AND ENROLLMENT PROCEDURES 
3.1 Inclusion Criteria 
1. Biopsy proven prostate adenocarcinoma 
2. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam 
or brachytherapy) 
a. Post radical prostatectomy (RP) – AUA recommendation (32) 


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i. PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical 
prostatectomy 
ii. Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA 
measurements greater than 0.2 ng/mL)  
b. Post-radiation therapy –ASTRO-Phoenix consensus definition (33) 
A rise of PSA measurement  
3. No evidence of metastatic disease on conventional imaging, including a negative bone 
scan for skeletal metastasis and negative CT scan, with or without contrast. NaF PET CT 
can substitute for separate bone scan and CT. CT in Axumin (also known as 18F FACBC 
or 18F Fluciclovine) can substitute for separate CT. 
4. Able to provide written consent 
5. Karnofsky performance status of 50 (or ECOG/WHO equivalent) 
3.2 Exclusion Criteria 
1. Less than 18 years-old at the time of radiotracer administration 
2. Unable to provide informed consent  
3. Inability to lie still for the entire imaging time  
4. Inability to complete the needed investigational and standard-of-care imaging examinations 
due to other reasons (severe claustrophobia, radiation phobia, etc.) 
5. Any additional medical condition, serious intercurrent illness, or other extenuating 
circumstance that, in the opinion of the Investigator, may significantly interfere with study 
compliance 
6. Metallic implants (contraindicated for MRI) 
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 36 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 68Ga-RM2 as the PET radiopharmaceutical. The administered dosage is 140 MBq i.v. 
Effective Doses (ED) of [68Ga]-DOTA Bombesin as calculated using OLINDA for the 
hermaphroditic male model, ranged between 0.028mSv/MBq and 0.051mSv/MBq depending on 
the bladder-voiding interval (0.75h, 1h or 2h). Consequently, the urinary bladder wall was the 
main contributor to the ED followed by the lower large intestinal wall, the gonads and the 


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stomach wall. Based on the fact that human pancreas expresses only low levels of GRPr in 
contrast to mouse and rat pancreas, which demonstrate extremely high expression levels, 
pancreas data of the biodistribution were not taken into account (but contributed to the remainder 
of the body). 
Table 1: Effective Doses and whole body doses for a 140 MBq 68Ga-DOTA-RM2 or 300 MBq 
18F FDG PET scan 
Tracer 
ED (mSv/ MBq) 
Whole Body Dose  
PET scan 
Whole Body Dose 
PET/ CT scan * 
[68Ga]DOTA-RM2  
(0.75h-void.)  
0.028 
3.92 mSv (140 MBq) 
6.92 mSv 
[68Ga]DOTA-RM2 
(1h-void.)  
0.034 
4.76 mSv (140 MBq) 
7.76 mSv 
[68Ga]DOTA-RM2 
(2h-void.)  
0.051 
7.14 mSv (140 MBq) 
10.14 mSv 
[18F]-FDG  
0.019** 
5.70 mSv (300 MBq) 
8.70 mSv 
* Low dose CT yields a dose of appr. 3 mSv (Brix et al.) 
** ICRP-80 
Measured human dosimetry data are available from published data (30) and presented below. 
68Ga-RM2 is 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 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 140-MBq injected radioactivity is 7.7 mSv, which could be reduced to roughly 4.76 mSv 
with frequent bladder voiding (1-h voids). 
Table 2: Dose Equivalent estimates (mSv/MBq) after injection of 68Ga-RM2 (n = 5) 
Organ 
Mean 
SD 
Minimum 
Maximum 
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 


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Table 2: Dose Equivalent estimates (mSv/MBq) after injection of 68Ga-RM2 (n = 5) 
Organ 
Mean 
SD 
Minimum 
Maximum 
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 
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-RM2 is the urinary bladder, followed by the pancreas.  The effective dose of 
68Ga-RM2 reported (0.051 mSv/MBq) is approximately twice as much as those 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) (34-37).   
4.2 Specify the source of the study agent.  
Molecular Imaging Program at Stanford 
Satellite Radiochemistry Facility  
300 Pasteur Dr, C21 
Stanford, CA 94305  
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/MRI 
5.2 Details of Imaging (i.e. dynamic, static, number of scans, etc.) 
A localizer MRI scan will be performed at 45 minutes after injection of 140 MBq of 68Ga-RM2 to 
define the table positions.  After correct positioning of the spatial acquisition windows is ensured, 
the combined PET/MRI acquisition will be initiated with 3–5 table positions at a 4-min acquisition 
time per table position.  A volumetric T1 acquisition with fat-water separation and motion 
correction to enable free-breathing will be obtained 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 T1 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.  As the T1 will take less than 4 minutes, a rapid diffusion weighted 
MRI will also be performed.  After completion of the PET acquisition, the table will be moved to the 


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next table position and the procedure will be repeated. Upon completion of the PET acquisition for 
all stations, volumetric post-contrast T1- and T2-weighted MR images may be obtained at multiple 
stations as needed. 
The PET emission scan is corrected using segmented attenuation data of the MRI scan.  The PET 
images are reconstructed with a standard iterative algorithm.  All images are 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/MRI scans will be interpreted by ABNM certified Nuclear Medicine physicians and an 
ABR certified Radiologists.  Drs  Iagaru, Davidzon, Loening and Vasanawala have significant 
clinical experience and will be blinded to the participants’ medical history and the results of other 
imaging 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 
Scan Date 
24 - 48 Hours 
Post-Study 
12 Months 
Informed consent 
X 
 
 
 
Demographics 
X 
 
 
 
Medical history 
X 
 
 
 
Follow-up Call to Participant 
 
 
X 
 
68Ga-RM2 
 
X 
 
 
Data analysis 
 
 
 
X 
8. ADVERSE EVENTS AND REPORTING PROCEDURES 
8.1 Potential Adverse Events 
The administration of the radioactive substance will feel like a slight pinprick when given by i.v. 
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.  
This research study involves exposure to radiation.  This radiation exposure is for research 
purposes only.  The amount of radiation from one 68Ga-RM2 PET/MR is 4.76 mSv, approximately 


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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.  
8.2 Adverse Event Reporting 
We do not anticipate hazardous situations for the subjects as a result of this protocol. However, 
standard of care procedures will be in place for verification of correct radiopharmaceutical dose 
and route of administration.  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 (eg, 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. 
9.2 Data Management Plan 
The CRFs will be stored in a locked office in the Cancer Clinical Trials Office.  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.  
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. 
The Research Monitor, Carina Mari Aparici, MD, in the Division of Nuclear Medicine and Molecular 
Imaging is responsible to oversee the safety of the research and report observations/findings to 
the IRB or a designated institutional official.  The Research Monitor will review all unanticipated 
problems involving risks to subjects or others associated with the protocol and provide an 
independent report of the event to the IRB.  The Research Monitor may discuss the research 
protocol with the investigators; shall have authority to stop a research protocol in progress, 
remove individual human subjects from a research protocol, and take whatever steps are 
necessary to protect the safety and well-being of human subjects until the IRB can assess the 
monitor's report; and shall have the responsibility to promptly report their observations and 
findings to the IRB or other designated official and the HRPO. 


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10. MEASUREMENTS 
10.1 Primary outcome measure 
The principal goal of this study is to compare the diagnostic performance of 68Ga-RM2 PET/MRI to 
that of MR alone for detecting recurrent prostate cancer in clinically (PSA) recurrent but CT 
negative cases.  The number and location of lesions will be recorded for each modality in each 
patient.  Gold standard will be based on either biopsy or one-year follow-up. 
Specifically, it is hypothesized that: 
1. At least 30% of these patients will have one or more lesions detected on 68Ga-RM2 PET/MRI. 
2. The proportion of patients with detected lesions will be higher for 68Ga-RM2 PET/MRI than for 
MR alone. 
10.2 Measurement Methods 
PET images will be interpreted using dedicated software and the location of uptake will be 
recorded for each patient, blinded to the results of other studies.  MR images will be evaluated for 
detection of areas of abnormal signal or anatomical structures, blinded to the results of PET or 
other studies. 
10.3 Measurement Time Points 
Uptake will be evaluated after the scan completion.  
11. STATISTICAL CONSIDERATIONS 
11.1  Statistical Design 
Prospective single center, single-arm study.  Patients will be scanned with 68Ga-RM2 PET/MRI 
after the CT scan.  MRI and PET/MRI scans will each be evaluated separately by two readers. 
11.2  Randomization 
No randomization will be done. 
11.3  Interim analyses 
No interim analyses are planned. 
11.4  Key variables 
Reference standard: disease status of a lesion will be defined by conventional imaging followed by 
biopsy of suspicious lesions, when clinically feasible.  12-months clinical follow-up will be gold 
standard if biopsy cannot be done.  
Test to be evaluated: 68Ga-RM2 positivity will be determined by the operator as uptake more than 
the liver (malignant) or less (benign).  Visual conspicuity against background on the diffusion 
weighted images and presence of an anatomically corresponding abnormality on the T1w and 
T2w images are the criteria for detecting a lesion on MRI. 
11.4.1  Analysis Population 
All lesions identified by 68Ga-RM2 PET/MRI.  
11.4.2  Analysis Plan 
Sensitivity and specificity of PET/MRI and MR alone will be compared by McNemar tests of paired 
proportions. 
11.5  Sample Size 


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We used the "paired proportions" power analysis procedure in Stata Release 14 to determine the 
sample size (36).  We expect that roughly 50% of patients will have lesions (as determined by 
biopsy or follow-up).  Assuming a difference in sensitivity for PET/MRI and MRI of 20 percentage 
points (eg, 70% vs 50%), a sample of 60 diseased patients will provide 90% power at 5% error to 
detect such a difference.  Assuming a difference in specificity for PET/MRI and MRI of 
20 percentage points (eg, 70% vs 90%), a sample of 60 non-diseased patients will provide 98% 
power at 5% error to detect such a difference. 
--11.6  Accrual estimates 
 
 
We expect to accrue a total of 125 participants for this study.  The 10 patients included in the pilot 
study were enrolled in less than 2 months. The participants evaluated in published data will not be 
included in the analysis. There are approximately 10 prostate cancer patients scanned each week 
using in Nuclear Medicine to evaluate for metastatic disease.  Our enrollment plan is achievable 
given our experience with other protocols and the expected support from the referring physicians, 
Drs. Hancock, Sonn and Srinivas. 


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3. 
Oh WK, Kantoff PW. Treatment of locally advanced prostate cancer: is chemotherapy 
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Jani AB. Management strategies for locally advanced prostate cancer. Drugs & aging. 
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5. 
Isbarn H, Wanner M, Salomon G, et al. Long-term data on the survival of patients with 
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6. 
Van Poppel H, Vekemans K, Da Pozzo L, et al. Radical prostatectomy for locally 
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7. 
Bott SRJ. Management of recurrent disease after radical prostatectomy. Prostate 
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8. 
Panebianco V, Sciarra A, Lisi D, et al. Prostate cancer: 1HMRS-DCEMR at 3&#xa0;T 
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Radiology. 2012;81:700-708. 
 
9. 
Beer AJ, Eiber M, Souvatzoglou M, Schwaiger M, Krause BJ. Radionuclide and hybrid 
imaging of recurrent prostate cancer. Lancet Oncol. 2011;12:181-191. 
 
10. 
Oyen RH, Poppel HPV, Ameye FE, Voorde WAVd, Baert AL, Baert LV. Lymph node 
staging of localized prostatic carcinoma with CT and CT-guided fine-needle aspiration biopsy: 
prospective study of 285 patients. Radiology. 1994;190:315-322. 
 
11. 
Harisinghani MG, Barentsz J, Hahn PF, et al. Noninvasive Detection of Clinically Occult 
Lymph-Node Metastases in Prostate Cancer. New England Journal of Medicine. 
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12. 
Iagaru A, Young P, Mittra E, Dick DW, Herfkens R, Gambhir SS. Pilot Prospective 
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MRI for Detection of Skeletal Metastases. Clinical Nuclear Medicine. 2013;38:e290-e296. 
 
13. 
Iagaru A, Mittra E, Dick D, Gambhir S. Prospective Evaluation of 99mTc MDP 
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Molecular Imaging and Biology. 2012;14:252-259. 
 
14. 
Sandblom G, SÃƒrensen J, Lundin N, HÃƒggman M, MalmstrÃƒm P-U. Positron 
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Oyama N, Miller TR, Dehdashti F, et al. 11C-Acetate PET Imaging of Prostate Cancer: 
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Wachter S, Tomek S, Kurtaran A, et al. 11C-Acetate Positron Emission Tomography 
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Souvatzoglou M, Weirich G, Schwarzenboeck S, et al. The Sensitivity of [11C]Choline 
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18. 
Rietbergen DDD, van der Hiel B, Vogel W, Stokkel MPM. Mediastinal lymph node 
uptake in patients with prostate carcinoma on F18-choline PET/CT. Nuclear medicine 
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19. 
Nanni C, Schiavina R, Boschi S, et al. Comparison of 18F-FACBC and 11C-choline 
PET/CT in patients with radically treated prostate cancer and biochemical relapse: preliminary 
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Turkbey B, Mena E, Shih J, et al. Localized prostate cancer detection with 18F FACBC 
PET/CT: comparison with MR imaging and histopathologic analysis. Radiology. 2014;270:849-
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21. 
Eiber M, Maurer T, Souvatzoglou M, et al. Evaluation of Hybrid 68Ga-PSMA Ligand 
PET/CT in 248 Patients with Biochemical Recurrence After Radical Prostatectomy. Journal of 
Nuclear Medicine. 2015;56:668-674. 
 
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Rowe SP, Gage KL, Faraj SF, et al. 18F-DCFBC PET/CT for PSMA-based Detection 
and Characterization of Primary Prostate Cancer. Journal of Nuclear Medicine. 2015. 
 
23. 
Jensen RT, Battey JF, Spindel ER, Benya RV. International Union of Pharmacology. 
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Reubi JC, Wenger S, Schmuckli-Maurer J, Schaer J-C, Gugger M. Bombesin Receptor 
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25. 
Markwalder R, Reubi JC. Gastrin-releasing Peptide Receptors in the Human Prostate: 
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26. 
Beer M, Montani M, Gerhardt J, et al. Profiling gastrin-releasing peptide receptor in 
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Mansi R, Wang X, Forrer F, et al. Development of a potent DOTA-conjugated bombesin 
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28. 
Minamimoto R, Hancock S, Schneider B, et al. Pilot Comparison of (6)(8)Ga-RM2 PET 
and (6)(8)Ga-PSMA-11 PET in Patients with Biochemically Recurrent Prostate Cancer. J Nucl 
Med. 2016;57:557-562. 
 
29. 
Roivainen A, Kähkönen E, Luoto P, et al. Plasma Pharmacokinetics, Whole-Body 
Distribution, Metabolism, and Radiation Dosimetry of 68Ga Bombesin Antagonist BAY 86-7548 
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30. 
Kähkönen E, Jambor I, Kemppainen J, et al. In Vivo Imaging of Prostate Cancer Using 


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[68Ga]-Labeled Bombesin Analog BAY86-7548. Clinical Cancer Research. 2013;19:5434-5443. 
 
31. 
Minamimoto R, Sonni I, Hancock S, et al. Prospective Evaluation of 68Ga-RM2 
PET/MRI in Patients with Biochemical Recurrence of Prostate Cancer and Negative Findings on 
Conventional Imaging. Journal of Nuclear Medicine. 2018;59:803-808. 
 
32. 
Cookson MS, Aus G, Burnett AL, et al. Variation in the definition of biochemical 
recurrence in patients treated for localized prostate cancer: the American Urological Association 
Prostate Guidelines for Localized Prostate Cancer Update Panel report and recommendations 
for a standard in the reporting of surgical outcomes. J Urol. 2007;177:540-545. 
 
33. 
Roach M, 3rd, Hanks G, Thames H, Jr., et al. Defining biochemical failure following 
radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: 
recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol 
Biol Phys. 2006;65:965-974. 
 
34. 
Hartmann H, ZÃƒphel K, Freudenberg R, et al. [Radiation exposure of patients during 
68Ga-DOTATOC PET/CT examinations]. Nuclear-Medizin. 2009;48:201-207. 
 
35. 
Pettinato C, Sarnelli A, Di Donna M, et al. 68Ga-DOTANOC: biodistribution and 
dosimetry in patients affected by neuroendocrine tumors. European journal of nuclear medicine 
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36. 
SandstrÃƒm M, Velikyan I, Garske-RomÃƒn U, et al. Comparative Biodistribution and 
Radiation Dosimetry of 68Ga-DOTATOC and 68Ga-DOTATATE in Patients with 
Neuroendocrine Tumors. The Journal of nuclear medicine. 2013;54:1755-1759. 
 
37. 
Kim J, Lee J, Kang K, et al. Whole-body distribution and radiation dosimetry of (68)Ga-
NOTA-RGD, a positron emission tomography agent for angiogenesis imaging. Cancer 
biotherapy and radiopharmaceuticals. 2012;27:65-71. 
 


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Inclusion/Exclusion Criteria Checklist  
 
Protocol Title: 
68Ga RM2 PET/MRI in Patients with Biochemically Recurrent Prostate 
Cancer and Non-Contributory Conventional Imaging  
Protocol Number: 
35155 
Principal Investigator: 
Andrei Iagaru, MD 
 
Inclusion Criteria – Yes must be checked to be eligible 
(From IRB-approved protocol) 
Yes 
No 
Supporting 
Documentation 
1.  Biopsy proven prostate adenocarcinoma  
☐ 
☐ 
☐ 
2. Rising PSA after definitive therapy with prostatectomy or 
radiation therapy (external beam or brachytherapy) 
a. Post radical prostatectomy (RP)  
ii. PSA greater than 0.2 ng/mL measured after at least 
6 weeks from radical prostatectomy 
ii. Confirmatory persistent PSA greater than 
0.2 ng/mL (total of two PSA measurements greater 
than 0.2 ng/mL)  
b. Post-radiation therapy  
c. i. A rise of PSA measurement of 2 or more ng/mL 
over the nadir 
☐ 
☐ 
☐ 
3. No evidence of metastatic disease on conventional 
imaging, including a negative bone scan for skeletal 
metastasis and negative CT scan, with or without 
contrast. NaF PET CT can substitute for separate bone 
scan and CT. CT in Axumin (also known as 18F FACBC 
or 18F Fluciclovine) can substitute for separate CT. 
☐ 
☐ 
☐ 
4. Able to provide written informed consent  
☐ 
☐ 
☐ 
5. Karnofsky performance status of 50 (or ECOG/WHO 
equivalent) 
☐ 
☐ 
☐ 
 
Exclusion Criteria –No must be checked to be eligible 
(From IRB-approved protocol) 
Yes 
No 
Supporting 
Documentation 
1. Patient is < 18 years old at the time of the drug 
administration 
☐ 
☐ 
☐ 
2. Unable to provide informed consent 
☐ 
☐ 
☐ 
3. Inability to lie still for the entire imaging time 
☐ 
☐ 
☐ 
4. Inability to complete the needed investigational and 
standard-of-care imaging examinations due to other 
reasons (severe claustrophobia radiation phobia, etc.) 
☐ 
☐ 
☐ 
5. Any additional medical condition, serious intercurrent 
illness, or other extenuating circumstance that, in the 
opinion of the Investigator, may significantly interfere 
with study compliance. 
☐ 
☐ 
☐ 
6. Metallic implants (contraindicated for MRI) 
☐ 
☐ 
☐ 


Version 13 
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*All subject files must include supporting documentation to confirm subject eligibility.  The method of confirmation 
can include, but is not limited to, laboratory test results, radiology test results, subject self-report, and medical record 
review.   
 
 
Statement of Eligibility 
By signing this form of this trial I verify that this subject is [☐eligible / ☐ ineligible] for participation in the 
study. This study is approved by the Stanford Cancer Institute Scientific Review Committee, the Stanford 
IRB, and has finalized financial and contractual agreements as required by Stanford School of Medicine’s 
Research Management Group.   
 
Signature: 
Date: 
Printed Name: 
 
Signature: 
Date: 
Printed Name: 
 
 
Signature: 
Date: 
Printed Name: 

ICF_001.pdf: 
 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
Page 1 of 13 
 
 
Iagaru / IRB-35155 ICF v10 July 2019   
IRB Use Only 
Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical 
Recurrence of Prostate Cancer and Non-Contributory CT Scans 
 
Are you participating in any other research studies? _____ Yes _____No 
PURPOSE OF RESEARCH  
You were selected as a possible subject in this study because you have been diagnosed with 
prostate cancer.  The purpose of this research study is to see if your tumor can be identified using 
a special procedure called a positron emission tomography (PET) scan.  PET/MRI is used to 
describe information regarding the function, as well as location and size of a tumor.  You will 
first have a localizer MRI, followed by an injection with a radioactive drug called 68Ga-RM2 that 
binds to tumor cells that have specific receptors and then have a PET scan.  We believe this 
special PET/MRI scan will be able to see smaller tumors than the standard of care CT or MRI 
scan.  68Ga-RM2 is considered investigational in the US, which means that it has not been 
approved by the US Food and Drug Administration (FDA).  
VOLUNTARY PARTICIPATION 
Your participation in this study is entirely voluntary.  Your decision not to participate will 
not have any negative effect on you or your medical care.  You can decide to participate now, 
but withdraw your consent later and stop being in the study without any loss of benefits or 
medical care to which you are entitled. 
If you decide to terminate your participation in this study, you should notify the research 
coordinators at 650-725-4711.   
This research study is looking for people diagnosed with prostate cancer that are suspected to 
have recurrent disease.  Stanford University expects to enroll 125 research study participants 
over 5 years. 
DURATION OF STUDY INVOLVEMENT  
If you agree to take part in this study, your involvement will include 1 visit (up to 3 hours). 
You may have an additional visit for a second 68Ga-RM2 PET/MRI scan.  This second scan will 
happen only if you receive treatment for your tumor, such as chemotherapy or biological therapy.  
This second 68Ga-RM2 PET/MRI scan is to determine how well your tumor responded.  
Each PET/MRI scan will require that you spend up to 3 hours in the Nuclear Medicine and 
Molecular Imaging Clinic.  
PROCEDURES 
If you choose to participate, Dr Andrei Iagaru and his research study staff will require the 
following: 
1. Participant will be asked to drink 1 to 2 glasses of water before arrival at the clinic 


 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
Page 2 of 13 
 
 
Iagaru / IRB-35155 ICF v10 July 2019   
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Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
2. Participants will be weighed and vital signs (heart rate, blood pressure, respiratory rate, pulse 
oxymetry) will be recorded 
3. Participant will be injected IV (intravenously) with 140 MBq of 68Ga-RM2 
4. Participant will void immediately prior to the scan 
5. Approximately 45 minutes after the 68Ga-RM2 (radiopharmaceutical) is administered 
through an IV, data acquisition will begin in the pelvic region and move toward the head.  
First, localizer MRI scans will be performed to define the table positions.  After correct 
positioning of the spatial acquisition windows is ensured, the combined PET/MRI acquisition 
will be initiated with 3 to 5 table positions at a 4-min acquisition time per table position. 
6. Participant will be given a copy of the consent form s/he signed and will be dismissed. 
7. Vital signs (heart rate, blood pressure, respiratory rate, pulse oxymetry) will be recorded 
again at the completion of the study. 
8. Participant will be contacted at 24 to 48 hours following the scan in order to capture potential 
late occurring Adverse Events. 
The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to 
therapy, if requested by the treating physician at the standard of care, 12 week follow-up time. 
You will be asked to lie very still during the scan because movement can interfere with the 
results.  You will be asked to breath normally during the scan.  During the scan, you might hear a 
humming noise but you will not feel anything unusual.  You may feel the table move while 
images are being taken at certain locations on your body.  Our technologist will monitor you 
during the exam. 
The MRI scanning procedure is very much like an X-ray CT scan.  You may be given an IV 
contrast injection to enhance the results of your study.  If you have had a previous reaction to 
Gadolinium-based contrast agents or a history of severe allergies, please notify the 
operator/investigator.  If you have kidney problems, please tell the operator.  You will be asked 
to lie on a long narrow couch for about 45 to 60 minutes while the machine gathers data.   
During this time you will not be exposed to X-rays, but rather a strong magnetic field and 
radiofrequency magnetic fields.  You will not feel either.  You will, however, hear repetitive 
tapping noises that arise from the MR scanner.  We will provide earplugs or headphones that you 
will be required to wear.  The space within the large magnet in which you lie is somewhat 
confined, although we have taken many steps to relieve the "claustrophobic" feeling. 
Your test results will be maintained as part of your Stanford medical record.  If you do not have a 
Stanford medical record, one will be created during this research study. 
If you are a man participating in this study and your partner is able to become pregnant, you and 
your partner must use adequate contraception while you are participating in the study.  Your 
doctor will discuss with you what methods of birth control are considered adequate.  You should 
inform your study doctor if your partner becomes pregnant. 


 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
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Iagaru / IRB-35155 ICF v10 July 2019   
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Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
PARTICIPANT RESPONSIBILITIES  
As a participant, your responsibilities include:  
 Follow the instructions of the Protocol Director and study staff. 
 Keep your study appointments.  If it is necessary to miss an appointment, please contact the 
Protocol Director or research study staff to reschedule as soon as you know you will miss the 
appointment. 
 Tell the Protocol Director or research study staff about any side effects, doctor visits, or 
hospitalizations that you may have. 
 Tell the Protocol Director or research staff if you believe you might be pregnant or gotten 
your partner pregnant. 
 Ask questions as you think of them. 
 Tell the Protocol Director or research staff if you change your mind about staying in the 
study. 
While participating in this research study, you should not take part in any other research project 
without approval from the Protocol Directors of each study.  This is to protect you from possible 
injury. 
WITHDRAWAL FROM STUDY 
If you first agree to participate and then you change your mind, you are free to withdraw your 
consent and discontinue your participation at any time.  Your decision will not affect your ability 
to receive medical care for your disease and you will not lose any benefits to which you would 
otherwise be entitled.  
If you withdraw from the study, please contact the study staff to let them know of your decision.  
You will receive a follow up phone call to ask if you had any adverse effects from your 
participation in the study. 
If you decided to withdraw from the study after the tracer is injected and before the scan is done 
we would like to observe you for any adverse reaction for up to an hour.  Once the IV’s have 
been removed it will be safe for you to leave. 
The Protocol Director may also withdraw you from the study without your consent for one or 
more of the following reasons: 
 Failure to follow the instructions of the Protocol Director and study staff 
 The Protocol Director decides that continuing your participation could be harmful to you 
 Pregnancy  
 You need treatment not allowed in the study. 
 The study is cancelled.  
 Other administrative reasons. 
 Unanticipated circumstances. 


 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
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Iagaru / IRB-35155 ICF v10 July 2019   
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Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
PET/MRI FOR FUTURE RESEARCH  
We would like to save the images and data from your PET/MRI scans for future research 
projects.  
You have the right to refuse to allow us the use of your data for future research.  You may 
withdraw from this study at any time.  If you decide later to withdraw from the study, the PHI 
obtained up until that withdrawal might be used in the study. 
Any images that are used in research may result in new products, tests, or discoveries.  In some 
instances, these may have potential commercial value and may be developed and owned by the 
Investigators, Stanford University and/or others.  However, participants in the study do not retain 
any property rights to the materials.  Therefore, you would not share in any financial benefits 
from these products, tests, or discoveries. 
Do you agree to allow us to store your data for future research?  
 Yes 
No   
Please initial _______________ 
POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES  
There are risks, discomforts, and inconveniences associated with any research study.  These 
deserve careful thought.  You should talk with the Protocol Director if you have any questions.  
Risks, discomfort and inconveniences include: 
 Time involved for the visits to the hospital 
 Bruising at the venipuncture/IV site for the radiopharmaceutical injection 
PET related risks: 
Reasonably foreseeable risks include: 
This research study involves exposure to radiation from the PET/MR radioactive compound 
68Ga-RM2.  This radiation exposure is not necessary for your medical care and is for research 
purposes only.  The additional amount of radiation exposure is about 4.76 mSv, which is 
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. 
 Physical risks – from study medications and procedures (eg, venipuncture, exposure to 
radiation. 
 This procedure may involve risks to you that are currently unforeseeable.  
MRI (MAGNETIC RESONANCE IMAGING) 
This MRI machine uses a strong magnet and radiofrequency magnetic fields to make images of 
the body interior.  


 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
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Iagaru / IRB-35155 ICF v10 July 2019   
IRB Use Only 
Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
RISKS of MRI: 
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.   
If you have a cardiac pacemaker or any other biomedical device in or on your body, it is very 
important that you tell the operator/investigator immediately.   
As metallic objects may experience a strong attraction to the magnet, it is also very important 
that you notify the operator of any metal objects (especially surgical clips), devices, or implants 
that are in or on your body before entering the magnet room.  All such objects must be removed 
(if possible) before entering the magnet room.  In some cases, having those devices means you 
should not have an MRI scan performed.  In addition, watches and credit cards should also be 
removed as these could be damaged.  You will be provided a way to secure these items.  
If you have any history of head or eye injury involving metal fragments, if you have ever worked 
in a metal shop, or if you could be pregnant, you should notify the operator/investigator.  You 
should also notify the operator/investigator if you have any tattoos on your body, including 
eyeliner and other permanent makeup.  Tattoos could become warm and irritated during the scan 
and remain so for several days.  If you would prefer not to participate in the MR scan due to the 
presence of tattoos on your body, please inform a research team member. 
There is a possibility that you will experience a localized twitching sensation due to the magnetic 
field changes during the scan.  This is expected and should not be painful.  
If you have had a previous reaction to Gadolinium-based contrast agents, a history of severe 
allergies, or a history of kidney disease, please notify the operator/investigator.   
Some of the hardware, imaging software and devices being used in your scan are not approved 
by the FDA, but are similar to counterparts that have been approved by the FDA.  There is a 
small risk of heating from the cables associated with these devices.  Please report any heating 
sensation immediately.   
IF YOU FEEL DISCOMFORT AT ANY TIME, NOTIFY THE OPERATOR AND YOU 
CAN DISCONTINUE THE EXAM AT ANYTIME. 
The scans performed in this study are for specific research purposes and are not optimized to find 
medical abnormalities.  The investigators for this project may not be trained to perform medical 
diagnosis.  The investigators and Stanford are not responsible for failure to find existing 
abnormalities with these MRI scans.  However, on occasion the investigator may notice a finding 
on an MRI scan that seems abnormal.  When this occurs, a physician will be consulted as to 
whether the findings merits further investigation, in which case the investigator will contact you 
and your primary care physician and inform you of the finding.  The decision as to whether to 
proceed with further examination or treatment lies solely with you and your physician.  The 
investigators, the consulting physician, and Stanford are not responsible for any examination or 
treatment that you undertake based on these findings.  Because the images collected in this study 


 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
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Iagaru / IRB-35155 ICF v10 July 2019   
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Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
may not comprise a proper clinical MRI scan, these images will not be made available for 
diagnostic purposes. 
Dizziness and nausea may occur if the head is moved rapidly within the bore of the magnet. 
POTENTIAL BENEFITS 
We don’t know if you will benefit from being in this study.  We may be able to see more cancer 
lesions compared to other scans.  If you receive a second 68Ga-RM2 PET/MRI scan after 
treatment, we may be able to determine how much response you had to the treatment. We hope 
that in the future others will benefit from this study because of knowledge gained in determining 
whether 68Ga-RM2 PET/MRI scans are more sensitive than the current standard of care scans for 
detecting prostate cancer and measuring response to treatment.   We cannot and do not 
guarantee or promise that you will receive any benefits from this study. 
ALTERNATIVES 
The alternative is to not participate in this study. 
PARTICIPANT’S RIGHTS 
You should not feel obligated to agree to participate.  Your questions should be answered clearly 
and to your satisfaction.  
If you decide not to participate, tell the Protocol Director.  You will still receive care for your 
disease and will not lose any benefits to which you would otherwise be entitled.  
You will be told of any important new information that is learned during the course of this 
research study, which might affect your condition or your willingness to continue participation in 
this study. 
CONFIDENTIALITY 
The results of this research study may be presented at scientific or medical meetings or published 
in scientific journals.  Your identity and/or your personal health information will not be disclosed 
except as authorized by you or as required by law.  However, there is always some risk that even 
de-identified information might be re-identified.  
Patient information may be provided to Federal and other regulatory agencies as required.  The 
Food and Drug Administration (FDA), for example, may inspect research records and learn your 
identity if this study falls within its jurisdiction. 
The purpose of this research study is to obtain data or information on the safety and effectiveness 
of 68Ga-RM2;  the results may be provided to the Food and Drug Administration, as well as to 
Piramal Imaging and the Department of Defense. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by US Law.  This Web site will not include information that can identify you.  At most, the Web 
site will include a summary of the results.  You can search this Web site at any time. 


 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
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Iagaru / IRB-35155 ICF v10 July 2019   
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Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
USE AND DISCLOSURE OF PROTECTED HEALTH INFORMATION 
Authorization To Use Your Health Information For Research Purposes  
Because information about you and your health is personal and private, it generally 
cannot be used in this research study without your written authorization.  If you 
sign this form, it will provide that authorization.  The form is intended to inform 
you about how your health information will be used or disclosed in the study.  
Your information will only be used in accordance with this authorization form and 
the informed consent form and as required or allowed by law.  Please read it 
carefully before signing it.   
What is the purpose of this research study and how will my health 
information be utilized in the study? 
This study will attempt to correlate the results of standard of care scans with 
68Ga-RM2 PET/MRI scan, in order to determine the best approach for evaluation 
of extent of prostate cancer.  Your health information related to this study, 
including but not limited to your medical history, lab results, and imaging results, 
may be used to correlate with the PET/MRI results.  Your health information may 
be used in scientific publications, but your identity will not be disclosed. 
Do I have to sign this authorization form? 
You do not have to sign this authorization form.  But if you do not, you will not be 
able to participate in this research study.  Signing the form is not a condition for 
receiving any medical care outside the study. 
If I sign, can I revoke it or withdraw from the research later? 
If you decide to participate, you are free to withdraw your authorization regarding 
the use and disclosure of your health information (and to discontinue any other 
participation in the study) at any time.  After any revocation, your health 
information will no longer be used or disclosed in the study, except to the extent 
that the law allows us to continue using your information (eg, necessary to 
maintain integrity of research).  If you wish to revoke your authorization for the 
research use or disclosure of your health information in this study, you must write 
to Dr Andrei Iagaru, 300 Pasteur Drive H2200, MC 5281, Stanford, CA 94305. 


 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
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Iagaru / IRB-35155 ICF v10 July 2019   
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Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
What Personal Information Will Be Used or Disclosed? 
Your health information related to this study may be used or disclosed in 
connection with this research study, including, but not limited to, your name, 
medical record number, medical history, sex, age, diagnosis, results of sans and 
pathology review, physical examination, lab tests, and imaging tests such as x-rays, 
CT scans, MRI scans, bone scans, and ultrasounds studies.  
Who May Use or Disclose the Information? 
The following parties are authorized to use and/or disclose your health information 
in connection with this research study: 
 Dr Andrei Iagaru (the Protocol Director) and members of the research team 
including technicians and research coordinators 
 The Stanford University Administrative Panel on Human Subjects in 
Medical Research and any other unit of Stanford University as necessary 
Who May Receive / Use the Information? 
The parties listed in the preceding paragraph may disclose your health information 
to the following persons and organizations for their use in connection with this 
research study: 
 The Office for Human Research Protections in the US Department of Health 
and Human Services 
 The Food and Drug Administration (FDA) 
 Piramal Imaging 
 The Department of Defense (DoD) 
Your information may be re-disclosed by the recipients described above, if they are 
not required by law to protect the privacy of the information. 
When will my authorization expire? 
Your authorization for the use and/or disclosure of your health information will 
expire December 31, 2070. 


 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
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Iagaru / IRB-35155 ICF v10 July 2019   
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Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
Will access to my medical record be limited during the study? 
To maintain the integrity of this research study, you may not have access to any 
health information developed as part of this study until it is completed.  At that 
point, you would have access to such health information if it was used to make a 
medical or billing decision about you (eg, if included in your official medical 
record).  
 
________________________________  
 
 
______________ 
Signature of Participant                            
 
 
Date & Time 
 
________________________________ 
Print Name of Participant   
 
 
_____________________________   
 
 
 
______________ 
Signature of Legally Authorized Representative (LAR)           
Date & Time 
(eg, parent, guardian or conservator) 
 
________________________________  
Print Name of LAR          
                                
________________________________________________________ 
LAR’s Authority to Act for Participant 
(eg, parent, guardian or conservator) 


 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
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Iagaru / IRB-35155 ICF v10 July 2019   
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Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
FINANCIAL CONSIDERATIONS 
PAYMENT:  You will be paid $250 for being in this research study after completion of PET MRI 
scan.  Payments may only be made to US citizens, legal resident aliens, and those who have a 
work eligible visa.  You may need to provide your social security number to receive payment. 
COSTS:  If you participate in this study, the study will pay for those services, supplies, 
procedures, and care associated with the study that are not a part of your routine medical care.  
However, there may be additional costs to you.  These include basic expenses like transportation 
and the personal time it will take to come to the study visits.  You and/or your health insurance 
must pay for services, supplies, procedures, and care that are required during this study for 
routine medical care.  You will also be responsible for any co-payments and/or deductibles 
as required by your insurance.  Participation in this study is not a substitute for health 
insurance. 
Piramal Imaging and the US Department of Defense are providing financial support and/or 
material for this study. 
COMPENSATION for Research-Related Injury 
All forms of medical diagnosis and treatment – whether routine or experimental – involve some 
risk of injury.  In spite of all precautions, you might develop medical complications from 
participating in this study.  If such complications arise, the Protocol Director and the research 
study staff will assist you in obtaining appropriate medical treatment.  In the event that you have 
an injury or illness that is directly caused by your participation in this study, reimbursement for 
all related costs of care first will be sought from your insurer, managed care plan, or other 
benefits program.  You will be responsible for any associated co-payments or deductibles as 
required by your insurance. 
If costs of care related to such an injury are not covered by your insurer, managed care plan or 
other benefits program, you may be responsible for these costs.  If you are unable to pay for such 
costs, the Protocol Director will assist you in applying for supplemental benefits and explain how 
to apply for patient financial assistance from the hospital. 
You do not waive any liability rights for personal injury by signing this form. 
CONTACT INFORMATION  
 Questions, Concerns, or Complaints:  If you have any questions, concerns or 
complaints about this research study, its procedures, risks and benefits, or 
alternative courses of treatment, you should ask the Protocol Director, 
Dr Andrei Iagaru.  You may contact him now or later at 650-725-4711.  
 Injury Notification:  If you feel you have been hurt by being a part of this study, 
please contact the Protocol Director, Dr Andrei Iagaru, at 650-725-4711. 
 Alternate Contact:  If you cannot reach the Protocol Director, please contact 
Dr Farshad Moradi, MD, at 650-736-1396.  


 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
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Iagaru / IRB-35155 ICF v10 July 2019   
IRB Use Only 
Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
 Independent Contact:  If you are not satisfied with how this study is being conducted, or 
if you have any concerns, complaints, or general questions about the research or your 
rights as a participant, please contact the Stanford Institutional Review Board (IRB) to 
speak to someone independent of the research team at 650-723-5244 or toll free at 
1-866-680-2906.  You can also write to the Stanford IRB, Stanford University, 1705 El 
Camino Real, Palo Alto, CA 94306. 
 Appointment Contact:  If you need to change your appointment, please contact 
Dr Andrei Iagaru and the research staff at 650-725-4711. 
EXPERIMENTAL SUBJECT’S BILL OF RIGHTS 
As a human subject you have the following rights.  These rights include but are not limited to the 
subject's right to: 
 
Be informed of the nature and purpose of the experiment;  
 
Be given an explanation of the procedures to be followed in the medical 
experiment, and any drug or device to be utilized;  
 
Be given a description of any attendant discomforts and risks reasonably to be 
expected;  
 
Be given an explanation of any benefits to the subject reasonably to be expected, 
if applicable;  
 
Be given a disclosure of any appropriate alternatives, drugs or devices that might 
be advantageous to the subject, their relative risks and benefits; 
 
Be informed of the avenues of medical treatment, if any available to the subject 
after the experiment if complications should arise;  
 
Be given an opportunity to ask questions concerning the experiment or the 
procedures involved;  
 
Be instructed that consent to participate in the medical experiment may be 
withdrawn at any time and the subject may discontinue participation without 
prejudice;  
 
Be given a copy of the signed and dated consent form; and  
 
Be given the opportunity to decide to consent or not to consent to a medical 
experiment without the intervention of any element of force, fraud, deceit, duress, 
coercion or undue influence on the subject's decision. 


 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
Page 12 of 13 
 
 
Iagaru / IRB-35155 ICF v10 July 2019   
IRB Use Only 
Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
Signing your name means you agree to be in this study and that you will receive a copy of this 
signed and dated consent form.  
 
_____________________________________ 
                    
 _____________________ 
Signature of Adult Participant 
 
 
 
   
   Date & Time 
 
_____________________________________             
 
Print Name of Adult Participant                                         
 
 
_____________________________________ 
                  
___________________         
Signature of Legally Authorized Representative (LAR) 
 
  Date & Time 
(e.g., parent, guardian or conservator)    
 
_____________________________________             
 
Print Name of LAR                                         
                             
  
_____________________________________ 
LAR’s Authority to Act for Participant  
 
 
(e.g., parent, guardian or conservator) 
 
 
_____________________________________ 
                   ____________________  
(If available) Signature of Other Parent or Guardian   
            Date & Time 
                       
_____________________________________             
 
Print Name of Other Parent or Guardian                                         
 
_____________________________________ 
Authority to Act for Participant  
 
 
 
 
 
 
_____________________________________ 
              ________ ____________  
Signature of Person Obtaining Consent 
 
 
        Date & Time 
 
 
_____________________________________             
 
Print Name of Person Obtaining Consent 


 
 
  STANFORD UNIVERSITY Research Consent Form 
 
Protocol Director:  Andrei Iagaru, MD 
Protocol Title:   
68Ga-RM2 PET/MRI in the Evaluation of Patients with Biochemical Recurrence of Prostate 
Cancer and Non-Contributory CT Scans 
 
 
 
 
 
Page 13 of 13 
 
 
Iagaru / IRB-35155 ICF v10 July 2019   
IRB Use Only 
Approval Date:   July 27, 2021 
Expiration Date:  July 27, 2022 
Participant ID: 
 
The following witness line is to be signed only if the consent is provided as a summary form and 
accompanied by a short form foreign language consent. 
 
 
_____________________________________                     ______________________ 
Signature of Witness                                                              Date&Time 
 
_____________________________________             
 
Print Name of Witness                                         
(e.g., staff, translator/interpreter, family member) 
 
 Translated short form must be signed and dated by both the participant (or their LAR) AND the witness. 
 The English consent form (referred to as the "Summary Form" in the regulations): 
 Must be signed by the witness AND the Person Obtaining Consent (POC). 
 The non-English speaking participant/LAR does not sign the English consent. 
 The non-English speaking participant/LAR should not sign the HIPAA participant line 
 If the participant or the LAR is non-English speaking, the Person Obtaining Consent (POC) must ensure 
that 1) the LAR's Description of Authority is completed and 2) that any questions or options presented by 
the consent form are documented and initialed by the POC on the Summary Form, per the participant's 
wishes, as they are understood during the consent process.