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



Status:Active, not recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:4/21/2016
Start Date:April 2015
End Date:April 2017

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

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.

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.

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
We found this trial at
1
site
900 Quarry Road Extension
Stanford, California 94305
(650) 723-5111
Stanford University Hospitals and Clinics A LEADER IN THE BIOMEDICAL REVOLUTION , Stanford Medicine has...
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from
Stanford, CA
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