Overview

This trial is active, not recruiting.

Condition prostate carcinoma
Treatments gallium ga 68-labeled grpr antagonist bay86-7548, magnetic resonance imaging, positron emission tomography
Sponsor Stanford University
Collaborator National Cancer Institute (NCI)
Start date April 2015
End date December 2015
Trial size 10 participants
Trial identifier NCT02440308, NCI-2015-00673, P30CA124435, PROS0069

Summary

This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin positron emission tomography (PET)/magnetic resonance imaging (MRI) in imaging 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 60 later.
gallium ga 68-labeled grpr antagonist bay86-7548
Receive 68Ga-DOTA-Bombesin IV
magnetic resonance imaging Magnetic Resonance Imaging Scan
Undergo 68Ga-DOTA-Bombesin PET/MRI
positron emission tomography Medical Imaging, Positron Emission Tomography
Undergo 68Ga-DOTA-Baombesin PET/MRI

Primary Outcomes

Measure
Biodistribution of 68Ga-DOTA-Bombesin
time frame: At time of imaging (1 hour)
Feasibility, determined by the number of participants to complete the examination
time frame: Up to 1 week

Eligibility Criteria

Male participants at least 19 years old.

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

Additional Information

Official title 68Ga-DOTA-Bombesin PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study
Principal investigator Andrei Iagaru
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 60 later. After completion of study, patients are followed up at 24 hours and 1 week.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Stanford University.
Location data was received from the National Cancer Institute and was last updated in June 2016.