Choline C 11 Injection Approved for Prostate Cancer Detection

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The FDA approved the production and use of Choline C 11 Injection by Mayo Clinic, a positron emission tomography (PET) imaging agent used to help detect recurrent prostate cancer.

Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific sites for follow-up tissue sampling and testing in men with recurrent prostate cancer. PET imaging with Choline C 11 Injection is performed in patients whose blood prostate specific antigen (PSA) levels increase after prior treatment for prostate cancer.

The safety and efficacy of Choline C 11 Injection were verified by a systematic review of published study reports. Four independent studies examined 98 patients with elevated blood PSA levels but no sign of recurrent prostate cancer on conventional imaging. After PET imaging with Choline C 11, the patients underwent tissue sampling of the detected abnormalities. Study results showed that at least half the patients who had abnormalities also had recurrent prostate cancer confirmed by tissue sampling of the abnormal areas.

For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319201.htm?source=govdelivery.

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