NCT01132599

Comparing PET-CT Using C-11 Choline and 18F-Fluoromethylcholine in Patients With Metastatic Prostate Cancer

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	C-11 choline
RADIATION	18F-fluoromethylcholine

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-06-01
• First posted: 2010-05-28
• Last updated: 2012-02-28

Locations

1 site across 1 country: United Kingdom