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Mayo Clinic gets FDA approval for new imaging agent for recurrent prostate cancer
Date:11/8/2012

Results database. Recurrent prostate cancer is defined as cancer that has recurred following initial therapy, which could include surgery, radiation therapy, hormone therapy or chemotherapy.

Choline C 11 Injection has a short shelf life and must be made in a specialized facility and given to patients within minutes after production. Mayo Clinic has the integrated production, imaging and pathology facilities to provide the benefit of Choline C 11 PET imaging to patients.

Choline C 11 Injection is a perfect fit for Mayo because its urologists see some of the most complex cases of recurrent prostate cancer in the country, Dr. Kwon says. He cautions that even with its advantage over conventional imaging, PET imaging with Choline C 11 injection is not a replacement for a tissue biopsy and histologic verification of recurrent prostate cancer.

"We worked very closely with the FDA to obtain approval to administer this agent," says Val Lowe, M.D., a radiologist at Mayo Clinic who worked on the new drug application. "The FDA understood our needs as an academic institution trying to bring novel technology to the clinician and they were very responsive."

The safety and effectiveness of Choline C 11 Injection were verified by a systematic review of published study reports.

Possible allergic reactions and mild injection site reactions may occur with the use of Choline C 11 Injection. However, no adverse reactions to Choline C 11 Injection have been reported other than a mild injection site reaction. Choline C 11 Injection contributes to a patient's long-term cumulative radiation exposure. Imaging errors have been reported; in particular, blood PSA levels < 2ng/ml have been associated with poor imaging performance.


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Contact: Joe Dangor
newsbureau@mayo.edu
507-284-5005
Mayo Clinic
Source:Eurekalert

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