The Food and Drug Administration has approved the production and use of choline C-11, an imaging agent used in positron emission tomography (PET) to detect prostate cancer. The compound is injected intravenously and has been found by the FDA to be virtually free of side effects except for mild skin irritation at the injection site experienced by a small minority of patients.
The FDA also announced that the Mayo Clinic is the first facility approved to manufacture C-11 choline injections for patients.
Dr. Charles Ganley, Director of the FDA’s Office of Drug Evaluation IV, said, « C-11 choline 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. . The FDA approval of C-11 Choline Injection at the Mayo Clinic provides assurance to patients and healthcare professionals that they are using a product that is safe, effective, and manufactured under current good manufacturing practices.
The safety of the imaging agent has been verified through a systematic peer review of published clinical trial reports.