The US Food & Drug Administration has approved the production and use of an imaging agent that aides in detecting prostate cancer in men whose disease is recurrent.
Choline C 11 is given to men intravenously prior to PET imaging. The agent creates an image doctors can use to identify sites in the body with residual disease for follow-up tissue sampling and other treatments.
The production of Choline C 11 Injection requires a specialized facility and it must be administered to patients shortly after it has been produced. The agent has been produced at unapproved facilities in the United States before, but the Food and Drug Administration Modernization Act directed the FDA to "establish appropriate approval procedures and current good manufacturing practice requirements for all PET products marketed and used in the United States." Consequently, the FDA has made the Mayo Clinic in Rochester, MN the first FDA-approved facility to produce Choline C 11 Injection.
“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,” said Charles Ganley, M.D., director of the Office of Drug Evaluation IV in FDA’s Center for Drug Evaluation and Research. “The FDA’s approval of Choline C 11 Injection at the Mayo Clinic provides assurance to patients and health care professionals they are using a product that is safe, effective, and produced according to current good manufacturing practices.”
Source: FDA
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