April 08, 2011
Breast Center medical director Linda Greer, MD, at the instant she started looking at our first 3D images. A true historical moment.
Valley women can now benefit from lifesaving three-dimensional mammography at John C. Lincoln's Breast Health and Research Center, the first place in Arizona where the technology is available. The only other place in the nation that has 3D mammography is Massachusetts General Hospital, where it was developed by a professor from the Harvard University College of Medicine.
The new technology, Selenia Dimensions, marketed by Hologic, Inc., is a 3D digital system known as tomosynthesis. Selenia Dimensions hardware was installed at John C. Lincoln's Breast Center last year, but could only be used for two-dimensional breast imaging, pending federal approval for groundbreaking 3D use, which finally came in March.
Tomosynthesis creates a series of images of thin layers of breast tissue that provide radiologists with a clearer picture. Images of thin layers of tissue eliminate confusing overlapping of tissue that is seen in conventional mammograms that may hide lesions or cause benign areas to appear suspicious. Tomosynthesis was designed to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density.
The Hologic tomosynthesis mammograms allow both 2D and 3D screening during a single compression that takes just seconds, and uses an x-ray dose below the FDA's acceptable maximum guidelines for screening mammography.
Results give radiologists the ability to compare a patient's previous standard 2D mammogram side-by-side with the new 3D images, as well as review more thorough information in the 3D format.
In clinical studies, radiologists reading 2D plus 3D mammography demonstrated:
- Superior clinical performance in specificity, the confidence to rule out breast cancer without recalling the patient for further study.
- Improved sensitivity, the proportion of mammograms which include breast cancers that were correctly diagnosed.
"This is critically important, especially for younger women with dense breast tissue, because it means we will be able to find and identify cancer at an earlier, more treatable stage," Gage said. "The bottom line? With this system we can save more lives."
The medical device had previously been approved and is in use in Europe, Latin America, Asia, Canada and Mexico.
A statement made Friday by the FDA said, "The limited technology (of traditional mammography) requires some women to have additional testing. Reviewing an additional 3D image helped doctors find more cancers than with 2D images alone."
The FDA noted that improved accuracy in detecting cancers with Hologic's tomosynthesis system decreased the number of women radiologists recalled for a diagnostic workups, a process which causes patient stress, inconvenience and additional radiation. Historically, approximately 10 percent of women who get screening mammograms undergo additional testing for abnormalities that are later determined to be noncancerous.
The National Cancer Institute recommends women ages 40 and older have a mammogram every one to two years. Nearly 40 million mammograms are performed each year in the United States.
For more information on 3D mammography or how to schedule an appointment visit JCL.com/tomo.
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