At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Expanded Access to 11C Choline PET/CT and 11C Choline PET/MR for Staging of Recurrent Prostate Cancer With Comparison Study of CT and MR Modalities
In Brief
A Phase 3 clinical trial evaluating 11C-choline Injection for Metastatic Prostate Cancer. Completed, enrolled 109 participants across 1 site.
Detailed Summary
This Phase 3 study will target approximately 100 men over age 18 who have a biochemical relapse or other evidence of relapse of prostate cancer after primary treatment. The purpose of this study is to: A. Provide expanded access the drug 11C-choline. B. Determine the performance characteristics (sensitivity, specificity, positive predictive value, negative predictive value) of 11C-choline PET/Computed Tomography (CT) and PET/Magnetic Resonance Imaging (MRI) in the detection of metastatic prostate cancer in patients with biochemical relapse of prostate cancer after primary treatment in a prospective manner. C. Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT and PET/MRI positive patients through a prospective study. D. Determine factors that predict a confirmed positive 11C-choline PET/CT and PET/MRI using a multivariable analysis of clinical and pathologic data collected prospectively. E. Compare the individual performance characteristics of 11C-choline PET/CT and 11C-choline PET/MRI and the combination of 11C-choline PET/CT and PET/MRI Study Protocol: 1. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan. 2. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. 3. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. 4. Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed with biopsy or surgical pathology when possible, or by response to treatment on subsequent imaging. 5. Rates of confirmed metastasis between conventional CT and MRI images will be compared with the 11C-choline PET CT and MRI images. 6. Upon conclusion of each imaging protocol, the referring physician will receive written documentation of the results. At this time, the patient will be considered off study and no further follow up is required.
Study Details
Timeline
Interventions
1. Choline C11 Injection for PET/CT Imaging Protocol: * 15 - millicuries (mCi) 11C-choline IV Injection * PET images skull base to mid thigh with 3 min per bed position * Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol * Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: * No IV contrast * High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs * Fusion of coronal and PET images