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

Stanford University

Status and phase: Terminated; Phase 1

Conditions: Metastatic Malignant Neoplasm in the Bone; Hormone-Resistant Prostate Cancer; Metastatic Prostate Carcinoma

Treatments: Procedure: Positron Emission Tomography; Procedure: Contrast-enhanced Magnetic Resonance Imaging; Procedure: Magnetic Resonance Imaging; Drug: Fludeoxyglucose F-18; Drug: Fluorine F 18 Sodium Fluoride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02429804

P30CA124435 (U.S. NIH Grant/Contract)

PROS0063 (Other Identifier)

NCI-2015-00553 (Registry Identifier)

96754 (Other Identifier)

ep 32653

Details and patient eligibility

About

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.

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.

Enrollment: 4 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)

Experimental group

Description:

Patients receive 18F NaF and 18F FDG 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.

Treatment:

Drug: Fluorine F 18 Sodium Fluoride

Procedure: Magnetic Resonance Imaging

Drug: Fludeoxyglucose F-18

Procedure: Contrast-enhanced Magnetic Resonance Imaging

Procedure: Positron Emission Tomography