Trials / Terminated
TerminatedNCT02429804
NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer
Combined "One Stop Shop" NaF/FDG PET/MRI Evaluation of Response to Xofigo® in mCRPC Patients: A Pilot Study
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- Male
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Hormone-Resistant Prostate Cancer
- Metastatic Malignant Neoplasm in the Bone
- Metastatic Prostate Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Contrast-enhanced Magnetic Resonance Imaging | Undergo contrast-enhanced MRI |
| DRUG | Fludeoxyglucose F-18 | Given IV |
| DRUG | Fluorine F 18 Sodium Fluoride | Given IV |
| PROCEDURE | Magnetic Resonance Imaging | Undergo PET/MRI |
| PROCEDURE | Positron Emission Tomography | Undergo PET/MRI |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2017-05-15
- Completion
- 2017-05-15
- First posted
- 2015-04-29
- Last updated
- 2017-05-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02429804. Inclusion in this directory is not an endorsement.