Stanford, California 94305


Purpose:

This pilot clinical trial studies combined fluorine F 18 sodium fluoride (NaF)/ fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and magnetic resonance imaging (MRI) in measuring response to a drug, radium Ra 223 dichloride (Ra-223), in treating patients with prostate cancer that has not responded to hormone therapy and has spread to other parts of the body. Combining NaF/FDG in a simultaneous PET/MRI scan may help doctors accurately measure how well patients respond to treatment with radium Ra 223 dichloride.


Study summary:

PRIMARY OBJECTIVES: I. Estimate the performance of simultaneous NaF/FDG PET/MRI for the prediction of treatment response in patients with metastatic castrate resistant prostate cancer (mCRPC). II. Estimate the performance of simultaneous NaF/FDG PET/MRI for detection of extra-skeletal disease progression during treatment in mCRPC patients. OUTLINE: Patients receive 18F NaF and 18F FDG intravenously (IV) over 30 seconds-1 minute and then undergo PET/MRI and contrast-enhanced MRI after 45-60 minutes. Patients undergo imaging at baseline, after course 3 (12 weeks), and after course 6 (24 weeks) of treatment with Ra-223. After completion of study, patients are followed up for up to 12 months.


Criteria:

Inclusion Criteria: - Provides written informed consent - Diagnosed with mCRPC and painful bone metastases, referred for Xofigo (radium Ra 223 dichloride) - Able to remain still for duration of the imaging procedure (about one hour) Exclusion Criteria: - Metallic implants


NCT ID:

NCT02429804


Primary Contact:

Principal Investigator
Andrei Iagaru
Stanford University

Omar Rutledge
Phone: 650-721-4089
Email: orutledge@stanford.edu


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States

Omar Rutledge
Phone: 650-721-4089
Email: orutledge@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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