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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Drug: 68Ga-DOTA-Bombesin
* Procedure: Magnetic Resonance Imaging (MRI) scan
* Procedure: Positron Emission Tomography (PET) scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-DOTA-Bombesin PET/MRI<br>Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later. | Drug: 68Ga-DOTA-Bombesin<br>* 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)<br>* Other names: Gallium-68-labeled GRPr Antagonist;Procedure: Magnetic Resonance Imaging (MRI) scan<br> <br> * Other names: Nuclear Magnetic Resonance (NMR) scan;Procedure: Positron Emission Tomography (PET) scan<br> <br> * Other names: Proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal Biodistribution of 68Ga-DOTA-Bombesin | 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. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 68Ga-DOTA-Bombesin Feasibility | 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. | Up to 1 week |