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

Phase 2

Completed

• Conditions: Prostate Carcinoma
• Interventions: Drug: 68Ga-DOTA-Bombesin; Procedure: Magnetic Resonance Imaging (MRI) scan; Procedure: Positron Emission Tomography (PET) scan

• Registration Number: NCT02440308
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-12
• Primary Completion: 2015-06-30
• Study Completion: 2015-06-30
• Status Verified: 2017-02
• Results First Submitted: 2017-02-28
• Results First Submitted QC: 2017-02-28
• Last Update Submitted: 2017-02-28
• Results First Posted: 2017-04-11
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-DOTA-Bombesin PET/MRI	68Ga-DOTA-Bombesin	Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
68Ga-DOTA-Bombesin PET/MRI	Magnetic Resonance Imaging (MRI) scan	Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
68Ga-DOTA-Bombesin PET/MRI	Positron Emission Tomography (PET) scan	Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford University Hospitals and Clinics; 🇺🇸 Stanford, California, United States