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Imaging agent designed to detect recurrent prostate cancer
The FDA approved the use of a PET imaging agent designed to help detect recurrent prostate cancer.
PET imaging with Choline C Injection can be performed in patients whose PSA levels increase after treatment. Elevated PSA suggests cancer may have returned, even if other conventional imaging tests — including CT — show no signs of cancer.
Choline C 11 Injection, administered through IV, helps produce an image that allows clinicians identify specific sites where follow-up tissue sampling and testing should be performed.
PET imaging with Choline C 11 Injection is not intended to replace tissue sampling and testing, according to an FDA press release.
Multiple facilities have performed PET imaging with Choline C 11 Injection over the past several years. However, the facilities that manufactured the injections used in those imaging procedures were not approved by the FDA to do so.
Under the FDA Modernization Act, the agency established approval procedures and manufacturing requirements for all PET products marketed and used in the United States. The Mayo Clinic became the first facility to receive FDA approval for 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," Charles Ganley, MD, director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research, said in the press release. "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."
The FDA evaluated the safety and effectiveness of Choline C 11 Injection based on results of four studies that involved a combined 98 patients. All patients had elevated PSA levels, but conventional imaging showed no indication of recurrent prostate cancer.
The patients underwent PET imaging with Choline C 11. Researchers then performed tissue sampling of abnormalities detected on PET scans.
In each study, at least half of the patients with PET-detected abnormalities had recurrent prostate cancer, according to the FDA release. The rates of false-positive PET scans in the four studies ranged from 15% to 47%, a finding that demonstrates the need for confirmatory tissue sampling of abnormalities detected with Choline C 11 Injection PET scans, according to the FDA.
The only adverse effect observed in the study patients was a mild skin reaction at the injection site.