This pilot trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron-emission tomography (PET)/magnetic resonance imaging (MRI) works in diagnosing participants with PSMA-positive tumors. Gallium Ga 68-labeled PSMA- is an imaging drug that binds to tumor cells and can be imaged using PET/MRI. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET/MRI, may help find the presence of cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02978586.
PRIMARY OBJECTIVE:
I. To determine the feasibility of using PET/magnetic resonance (MR) with gallium Ga 68 (Ga-68) PSMA for staging and treatment monitoring of PSMA expressing tumors.
SECONDARY OBJECTIVES:
I. To compare early changes in PET biomarker ([Ga-68] PSMA) tumor uptake with treatment response assessed at completion of therapy (prediction of treatment response).
II. To compare changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy.
III. To compare results from multi-parametric MR imaging with [Ga-68] PSMA uptake.
IV. To assess combinations of quantitative PET and MRI metrics.
OUTLINE:
Participants receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Participants undergo PET/MRI over 90 minutes at baseline and 2-6 weeks after start of treatment. Participants may undergo optional PET/MRI before the start of treatment.
After completion of study, participants are followed up for up to 30 days.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorNorbert Avril
