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

Stanford University

Status and phase: Completed; Phase 2

Conditions: Prostate Carcinoma

Treatments: Procedure: Positron Emission Tomography (PET) scan; Procedure: Magnetic Resonance Imaging (MRI) scan; Drug: 68Ga-DOTA-Bombesin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02440308

P30CA124435 (U.S. NIH Grant/Contract)

NCI-2015-00673 (Registry Identifier)

PROS0069 (Other Identifier)

IRB-32319

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

68Ga-DOTA-Bombesin PET/MRI

Experimental group

Description:

Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.

Treatment:

Drug: 68Ga-DOTA-Bombesin

Procedure: Magnetic Resonance Imaging (MRI) scan

Procedure: Positron Emission Tomography (PET) scan