FDA approves PET agent to detect recurrent PCa

September 26, 2012

The FDA has approved the production and use of Choline C 11 Injection, a positron emission tomography agent used to help detect recurrent prostate cancer.

The FDA has approved the production and use of Choline C 11 Injection, a positron emission tomography agent used to help detect recurrent prostate cancer.

Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific body sites for follow-up tissue sampling and testing in men with 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," said Charles Ganley, MD, of the Office of Drug Evaluation IV in FDA’s Center for Drug Evaluation and Research.

The safety and effectiveness of Choline C 11 Injection were verified by a systematic review of published study reports. Four independent studies examined a total of 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 abnormalities detected on the PET scans.

In each of the four studies, at least half the patients who had abnormalities detected on PET scans also had recurrent prostate cancer confirmed by tissue sampling of the abnormal areas. PET scan errors also were reported. Depending on the study, falsely positive PET scans were observed in 15% to 47% of the patients. These findings underscore the need for confirmatory tissue sampling of abnormalities detected with Choline C 11 Injection PET scans, according to the FDA.

Aside from an uncommon, mild skin reaction at the injection site, no side effects to Choline C 11 Injection were reported.

The agent must be produced in a specialized facility and administered to patients shortly after its production. The Mayo Clinic PET Radiochemistry Facility in Rochester, MN is the first FDA-approved facility to produce the agent.

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