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
- 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
After completion of study treatment, patients are followed between 3-7 days.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Masking: Open Label, Primary Purpose: Diagnostic
Identification of a true 5% difference in lesion detection using 18F-fluoromethylcholine versus C-11 choline
Michael O'Doherty, MD
St. Thomas' Hospital
United Kingdom: Medicines and Healthcare Products Regulatory Agency