The FDA has approved the production and use of PET imaging agent Choline C 11 injection for identifying recurrent prostate cancer.
The Mayo Clinic in Rochester, Minn., was cleared as the first facility to manufacture Choline C 11 injections, the agency announced.
Choline C 11 has been used for several years, but the new approval procedures and good manufacturing practice requirements under the FDA Modernization Act opened the door for specialized facilities to produce the imaging agent.
PET imaging with Choline C 11 is used in patients who have rising levels of blood prostate specific antigen (PSA), the protein produced by the prostate gland. Elevated PSA levels can indicate a cancer recurrence even when traditional imaging studies, such as CT scans, show no signs of the disease. Choline C 11 injections help pinpoint the site of prostate cancers in recurrent cases when these other imaging tests come back negative.
Mayo Clinic researchers published a study on the efficacy of Choline C 11 injections in patients with recurrent prostate cancer in 2011 in the Journal of Nuclear Medicine. This research determined Choline C 11 use enhances prostate cancer lesion detection by roughly 30 percent.