NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer
- Conditions
- Metastatic Malignant Neoplasm in the BoneHormone-Resistant Prostate CancerMetastatic Prostate Carcinoma
- Interventions
- Procedure: Contrast-enhanced Magnetic Resonance ImagingDrug: Fluorine F 18 Sodium FluorideProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography
- Registration Number
- NCT02429804
- Lead Sponsor
- Stanford University
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 4
- 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)
- Metallic implants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI) Contrast-enhanced Magnetic Resonance Imaging 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. Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI) Fludeoxyglucose F-18 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. Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI) Fluorine F 18 Sodium Fluoride 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. Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI) Magnetic Resonance Imaging 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. Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI) Positron Emission Tomography 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.
- Primary Outcome Measures
Name Time Method Percent reduction at 12 weeks in NaF/FDG PET standardized uptake value 12 weeks Dichotomized treatment response at 24 weeks, based on technetium Tc-99m medronate (99mTc-MDP) bone scintigraphy intensity 24 weeks Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.
Dichotomized treatment response at 24 weeks, based on computed tomography (CT) lesion size 24 weeks Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.
Dichotomized treatment response at 24 weeks, based on alkaline phosphatase (ALP) measurements (per lesion analysis) 24 weeks Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.
Percent reduction at 12 weeks in MRI lesion size (per lesion analysis) 12 weeks
- Secondary Outcome Measures
Name Time Method Presence of new or regrowing extra-skeletal disease at 12 and/or 24 weeks on NaF/FDG PET/MRI that is not present on corresponding standard-of-care 99mTc-MDP bone scintigraphy and CT (per lesion analysis) Up to 24 weeks True status (true positive or false positive) of such lesions after 12 months of follow-up, based on all information except NaF/FDG PET/MRI (per lesion analysis) 12 months The true positive fraction of progressions detected only with NaF/FDG PET/MRI will be estimated with 95% confidence intervals.
Trial Locations
- Locations (1)
Stanford University, School of Medicine
🇺🇸Stanford, California, United States