Navigation Links
Mayo Clinic gets FDA approval for new imaging agent for recurrent prostate cancer

ROCHESTER, Minn. -- Mayo Clinic has received U.S. Food and Drug Administration approval to produce and administer Choline C 11 Injection, an imaging agent used during a positron emission tomography (PET) scan to help detect sites of recurrent prostate cancer. Mayo Clinic is the first, and currently only, institution in North America approved to produce this imaging agent.

VIDEO ALERT: Video interviews and animation are available for journalists to download on the Mayo Clinic News Network.

Choline C 11 Injection is a radioactive form of the vitamin choline. Clinicians inject a small amount of the agent into a patient's vein and then use a PET scanner and computer to make detailed pictures of areas where the agent collects. Since cancer cells take up more Choline C 11 than do normal cells, the pictures can be used to help find areas of possible cancer in the body when bone scintigraphy, computerized tomography or magnetic resonance imaging is non-informative. Once a site is identified, a biopsy and pathologic examination can verify whether prostate cancer has recurred.

Evaluating men for prostate cancer recurrence has long been a major challenge; physicians have had to wait until a patient's prostate-specific antigen (PSA) levels rose to values between 20-30 ng/mL to identify sites of recurrent prostate cancer.

"This technology is a game changer," says Eugene Kwon, M.D., a urologist at Mayo Clinic. "In stark contrast to conventional imaging, PET imaging with Choline C 11 Injection can help identify sites of recurrence for tissue sampling and examination when a patient's PSA level reaches

2 ng/mL months or even years earlier than before. This technology also allows us to pinpoint the locations of recurrent cancer more accurately and permits us to develop more effective treatment strategies."

About 90,000 men annually seek treatment for recurrent prostate cancer, according to the Surveillance, Epidemiology and End 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.


Contact: Joe Dangor
Mayo Clinic

Related medicine news :

1. Lower GI problems plague many with rheumatoid arthritis, Mayo Clinic study finds
2. First targeted nanomedicine to enter human clinical studies
3. Clinical insight improves treatment with new lung cancer drug
4. Clinical news alert from the American Academy of Orthopaedic Surgeons
5. Mayo Clinic launches whole genome breast cancer study
6. Mayo Clinic offers newly approved treatment for acid reflux disease
7. NYU Langone experts present research, clinical advances at neurosurgeons meeting
8. Mayo Clinic breast cancer study finds new type of mutation
9. Kroenke honored for outstanding contributions in clinical research training
10. Awards celebrate clinical research that can improve health and alleviate suffering
11. Association for Psychological Science, SAGE launch Clinical Psychological Science
Post Your Comments:
(Date:11/27/2015)... ... November 27, 2015 , ... The print component ... Today in Atlanta, Dallas, New York, Minneapolis, South Florida, with a circulation of ... distributed nationally, through a vast social media strategy and across a network of ...
(Date:11/27/2015)... , ... November 27, 2015 , ... ... the well-respected Microsoft Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s official group ... group of Microsoft Dynamics SL software users, partners, industry experts and representatives. Intellitec ...
(Date:11/27/2015)... ... ... CBD College is proud to announce that on November 20th, ... its Diagnostic Medical Sonography program. CBD College is honored to join this very short ... universities in the state of California make the cut. CBD College is officially the ...
(Date:11/27/2015)... ... November 27, 2015 , ... Indosoft Inc., ... the incorporation of Asterisk 11 LTS (Long Term Support) into its Q-Suite 5.10 ... brings Q-Suite 5.10 up-to-date with a version of Asterisk that will receive not ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... Representative. As a franchise owner, Somu now offers travelers, value and care based ... packages, private cruise sales, as well as, cabin upgrades and special amenities such ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 26, 2015 ... aanpak combineert immunotherapie met Bremachlorin-photodynamische therapie voor ... ) --> ... ) Uit ... Centrum (LUMC) blijkt ...
(Date:11/26/2015)... 26, 2015 Research and Markets ( ) ... Pacemaker Market Outlook to 2019 - Rise in Cardiac Disorders ... report to their offering. Boston ... Boston scientific and others. --> ... Biotronik, Boston scientific and others. ...
(Date:11/26/2015)... Nov. 26, 2015 Research and Markets ... the "2016 Future Horizons and Growth Strategies ... Supplier Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> --> This ... the Japanese therapeutic drug monitoring market, including emerging ...
Breaking Medicine Technology: