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

Arms (1)

1. type

   EXPERIMENTAL

   label

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

   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.

   interventionNames

   1. Procedure: Contrast-enhanced Magnetic Resonance Imaging
   2. Drug: Fludeoxyglucose F-18
   3. Drug: Fluorine F 18 Sodium Fluoride
   4. Procedure: Magnetic Resonance Imaging
   5. Procedure: Positron Emission Tomography

Primary outcomes (5)

1. measure

   Dichotomized treatment response at 24 weeks, based on technetium Tc-99m medronate (99mTc-MDP) bone scintigraphy intensity

   timeFrame

   24 weeks

   description

   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.