Thermography produces an infrared image (left) that shows the patterns of heat and blood flow on or near the surface of the body. A mammogram (right) is an x-ray of the breast in which a cancerous mass shows up in white. (Images courtesy of the FDA)
The FDA is advising women and doctors not to be misled by claims that thermography—a technique that uses infrared light to identify patterns of heat and blood flow near the body's surface—can be used as a stand-alone tool to detect breast cancer.
"The FDA is not aware of any valid scientific data to show that thermographic devices, when used on their own, are an effective screening tool for any medical condition, including the early detection of breast cancer or other breast disease," the agency stated in an alert issued June 2.
So far this year, the agency has issued three warning letters to practitioners and manufacturers of thermography devices for claiming that the technique can replace mammography.
"Mammography is still the most effective screening method for detecting breast cancer in its early, most treatable stages," Dr. Helen Barr, director of the Division of Mammography Quality and Radiation Programs in the FDA's Center for Devices and Radiological Health, said in a press release.
"While there is plenty of evidence that mammography is effective in breast cancer detection, there is simply no evidence that thermography can take its place," Dr. Barr continued.
Thermography devices have been cleared by the FDA for use as an adjunct, or additional, tool for detecting breast cancer. No randomized clinical trials, the gold standard for demonstrating effectiveness of a medical treatment or diagnostic test, have assessed the ability of thermography to detect breast cancer.
NCI Cancer Bulletin for June 14, 2011 - National Cancer Institute
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