68Ga-DOTA-Bombesin PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study
Overview
- Phase
- Phase 2
- Intervention
- 68Ga-DOTA-Bombesin
- Conditions
- Prostate Carcinoma
- Sponsor
- Stanford University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Normal Biodistribution of 68Ga-DOTA-Bombesin
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
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.
Investigators
Andrei Iagaru
Associate Professor of Radiology
Stanford University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
68Ga-DOTA-Bombesin PET/MRI
Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
Intervention: 68Ga-DOTA-Bombesin
68Ga-DOTA-Bombesin PET/MRI
Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
Intervention: Magnetic Resonance Imaging (MRI) scan
68Ga-DOTA-Bombesin PET/MRI
Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
Intervention: Positron Emission Tomography (PET) scan
Outcomes
Primary Outcomes
Normal Biodistribution of 68Ga-DOTA-Bombesin
Time Frame: 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)