68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer

NCT02440308 — Phase 2, Completed, 10 participants, Stanford University

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68Ga-DOTA-Bombesin PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study

Registry	NCT02440308
Status	Completed
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	10 (Actual)
Sponsor	Stanford University (Other); collaborators: National Cancer Institute (NCI)
Conditions	Prostate Carcinoma
Interventions	68Ga-DOTA-Bombesin, Magnetic Resonance Imaging (MRI) scan, Positron Emission Tomography (PET) scan (Drug, procedure)
Dates	start 2015-04-01, primary completion 2015-06-30, completion 2015-06-30, first posted 2015-05-12, last updated 2017-04-11
Locations	1 site in United States

-Summary

This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow doctors to identify smaller tumors than standard imaging.

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+Detailed description

PRIMARY OBJECTIVES:

I. To evaluate the feasibility and biodistribution of 68Ga-DOTA-Bombesin (BAY 86-7548 or 68Ga-DOTA RM2).

OUTLINE:

Patients receive 68Ga-DOTA-Bombesin intravenously (IV) and then undergo PET/MRI approximately 1 hour later.

After completion of study, patients are followed up at 24 hours and 1 week.

+Arms and interventions

Arm	Type	Interventions	Description
68Ga-DOTA-Bombesin PET/MRI	Experimental	Drug: 68Ga-DOTA-Bombesin; Procedure: Magnetic Resonance Imaging (MRI) scan; Procedure: Positron Emission Tomography (PET) scan	Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.

68Ga-DOTA-Bombesin (Drug), also known as 68Ga-DOTA RM2, BAY 86-7548, Gallium-68-labeled GRPr Antagonist: 68Ga-DOTA-Bombesin is a gallium-68-labeled gastrin-releasing peptide receptor (GRPr) antagonist. DOTA is \[4,7,10-Tris-(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl\]-acetyl. 68Ga-DOTA-Bombesin is administered intravenously (IV)
Magnetic Resonance Imaging (MRI) scan (Procedure), also known as Nuclear Magnetic Resonance (NMR) scan
Positron Emission Tomography (PET) scan (Procedure), also known as Proton magnetic resonance spectroscopic imaging

+Outcome measures

Primary outcomes

Normal Biodistribution of 68Ga-DOTA-Bombesin [1 hour]: Radiopharmaceutical uptake in normal organs will be evaluated visually and measured semi-quantitatively using standardized uptake values (SUV) derived from the PET/CT scan software in patients with prostate cancer. Uptake values in different tissues will be measured as SUVmean (mean value for SUV). SUVmean values reflect relative uptake of the radiolabel into the tissue.

Secondary outcomes

68Ga-DOTA-Bombesin Feasibility [Up to 1 week]: Feasibility of 68Ga-DOTA-Bombesin as a radiopharmaceutical for PET/MRI was assessed as the percentage of enrolled subjects who complete the examination, and for which the PET/MRI data were evaluable.

+Eligibility

Sex: Male, ages: 19 Years to any

INCLUSION CRITERIA

* Provides written informed consent
* Known diagnosis of prostate cancer
* Patient has suspected recurrence based on biochemical data \[prostate-specific antigen (PSA) > 2 ng/mL\]
* Able to remain still for duration of each imaging procedure (about one hour)

EXCLUSION CRITERIA

* Unable to provide informed consent
* Inability to lie still for the entire imaging time
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
* Metallic implants

+Posted results

Participant flow

Milestone	68Ga-DOTA-Bombesin PET/MRI
Started	10
Completed	10
Not completed	0

Outcome results

Normal Biodistribution of 68Ga-DOTA-Bombesin (Primary), Mean, SUV-mean: 68Ga-DOTA-Bombesin PET/MRI 2.28 +/- 0.68
68Ga-DOTA-Bombesin Feasibility (Secondary), Number, percentage of participants: 68Ga-DOTA-Bombesin PET/MRI 100

Adverse events

Arm	Deaths	Serious adverse events	Other adverse events
68Ga-DOTA-Bombesin PET/MRI	0/10 (0.0%)	0/10 (0.0%)	0/10 (0.0%)

+Locations (1)

Facility	City	Country	Status
Stanford University Hospitals and Clinics	Stanford, California	United States

+Publications

Results publication: Minamimoto R, Hancock S, Schneider B, Chin FT, Jamali M, Loening A, Vasanawala S, Gambhir SS, Iagaru A. 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 Apr;57(4):557-62. doi: 10.2967/jnumed.115.168393. Epub 2015 Dec 10. PMID 26659347

+Investigators

Andrei Iagaru, Principal investigator, Stanford University Hospitals and Clinics

+Funding

NIH grants: P30CA124435