Expired Study
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Stanford, California 94305


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02440308


Primary Contact:

Principal Investigator
Andrei Iagaru
Stanford University Hospitals and Clinics


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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