Comparing PET-CT Using C-11 Choline and 18F-Fluoromethylcholine in Patients With Metastatic Prostate Cancer
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) and computed tomography (CT) imaging, may help find and diagnose metastatic prostate cancer.
PURPOSE: This phase II trial is studying the side effects of C-11 choline and 18F-fluoromethylcholine and to see how well they work when used in PET and CT imaging in patients with metastatic prostate cancer.
Dietary Supplement: C-11 choline
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Cancer Research UK Phase II Trial to Compare [11C]Choline and [18F]Choline Each Given as a Single Administration Via Intravenous Injection for Imaging Patients With Metastatic Prostate Cancer|
- Identification of a true 5% difference in lesion detection using 18F-fluoromethylcholine versus C-11 choline [ Designated as safety issue: No ]
- Identification of a true 5% difference in lesion detection between the best early-phase scanning, using either the 18F-fluoromethylcholine and C-11 choline, and late-phase scanning using 18F-fluoromethylcholine [ Designated as safety issue: No ]
- Causality of each adverse event to C-11 choline and 18F-fluoromethylcholine and adverse event severity according to NCI CTCAE version 4.0 [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
- To compare C-11 choline to 18F-fluoromethylcholine using positron emission tomography and computed tomography imaging in their ability to detect metastatic prostate cancer.
- To compare the best early-phase (immediate) scanning of the two agents against the late-phase (one-hour delayed) 18F-fluoromethylcholine scanning in their ability to detect metastatic prostate cancer.
- To assess the safety of C-11 choline and 18F-fluoromethylcholine in these patients.
OUTLINE: Patients receive C-11 choline IV followed by a 10-minute dynamic positron emission tomography (PET) scan over the pelvis and then 5-minute scans at each bed position, from the pelvis to the base of the skull, (up to a maximum of 7 additional bed positions) lasting up to 45 minutes on day 1. Beginning 3 hours later, patients receive 18F-fluoromethylcholine IV followed by the same scanning protocol above lasting approximately 45 minutes. An additional 1-hour delayed PET-computed tomography (CT) scanning is then performed, which involves a 5-minute scan at each bed position from the pelvis to the base of the skull (up to a maximum of 7 bed positions) with 18F-fluoromethylcholine, lasting approximately 35 minutes. Patients then undergo treatment as per the normal standard of care following participation in this trial.
After completion of study treatment, patients are followed between 3-7 days.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132599
|St. Thomas' Hospital|
|London, England, United Kingdom, SE1 7EH|
|Principal Investigator:||Michael O'Doherty, MD||St. Thomas' Hospital|