The Food and Drug Administration has approved the production and use of the imaging agent Choline C 11 for the detection of recurrent prostate cancer.
"Choline C 11 injection provides an important imaging method to help detect the location of prostate cancer in patients whose blood tests suggest recurrent cancer when other imaging tests are negative," noted Dr. Charles Ganley, director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research, in an FDA statement.
Several imaging facilities have been performing PET imaging with Choline C 11 for the past couple of years, but none were approved by the FDA to manufacture the agent. The Mayo Clinic, which manufactures and distributes the agent in its Rochester, Minn., facility, is the first FDA-approved center to produce Choline C 11 injection.
The safety and effectiveness of Choline C 11 were verified after a review of four independent studies of 98 patients. In at least half of the patients in each study, prostate cancer detected by PET imaging was confirmed by tissue sampling of the abnormal areas.
There were also PET scan errors and false positive scans, which "underscore the need for confirmatory tissue sampling of abnormalities detected with Choline C 11 injection PET scans," according to the FDA statement.
No side effects of Choline C 11 were observed, except for mild skin reactions at the injection site.