FDA Approves Imaging Agent that Helps Detect Prostate Cancer
The Food and Drug Administration (FDA) has approved the production and use of Choline C 11 Injection, an imaging agent used with positron emission tomography (PET) scans to help detect prostate cancer that has returned.
Choline C 11 Injection is administered intravenously to produce an image that helps to identify specific body sites for follow-up tissue sampling and testing in men whose prostate-specific antigen (PSA) levels have risen after earlier prostate cancer treatment.
The imaging agent must be made in a specialized facility and used shortly after its production. The Mayo Clinic is now the first FDA-approved facility to produce Choline C 11 Injection.
The safety and effectiveness of the imaging agent were verified by four independent studies. The studies examined a total of 98 patients with elevated PSA levels but no sign of recurrent prostate cancer with conventional imaging.
In each of the four studies, recurrent prostate cancer was confirmed by tissue sampling in at least half of the men who had abnormalities detected on PET scans with Choline C 11 imaging. PET scan errors were also reported. Depending on the study, false-positive PET scans were observed in 15 to 47 percent of the men. These findings underscore the need to confirm findings with tissue samples when abnormalities are detected with Choline C 11 Injection PET scans, the FDA noted in a press release.
Aside from a mild skin reaction at the injection site, no side effects to Choline C 11 Injection were reported.