Prostate Cancer Clinical Trial

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NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer

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Summary

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.

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Full Description

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.

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Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

4

Study ID:

NCT02429804

Recruitment Status:

Terminated

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford University, School of Medicine
Stanford California, 94305, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

4

Study ID:

NCT02429804

Recruitment Status:

Terminated

Sponsor:


Stanford University

How clear is this clinincal trial information?

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