Breast Cancer

Looking Toward Changes in Breast-Cancer Detection

Scientists at the Food and Drug Administration are studying the next generation of screening and diagnostic devices, some of which borrow from the world of entertainment. Soon, three-dimensional (3D) images in actual 3D might help your doctor find hidden tumors and better diagnose cancers, thanks to the regulatory work being done by a team at FDA’s Division of Imaging, Diagnostics, and Software Reliability.

The team is led by Division Director Kyle Myers, a physicist with a Ph.D. in optical sciences. It includes Aldo Badano, Ph.D., a world-renowned expert in display evaluation technology, and Brian Garra, M.D., a diagnostic radiologist doing research in regulatory science at FDA.

The team is studying how clinicians receive visual information and analyze it to diagnose a disease. At the center of their research are breast cancer screening devices, which are making the leap from traditional two-dimensional (2D) screening such as mammography to 3D breast tomosynthesis, 3D ultrasound and breast computerized tomography (CT). This technology is very exploratory and years away from becoming standard in your doctor’s office.

New Era in Breast Cancer Detection

There are many new technologies being developed for breast cancer screening, especially 3D alternatives that may eventually replace today’s 2D mammography. FDA has already approved two of these state-of-the-art devices: The Selenia Dimensions 3D System, which provides 3D breast tomosynthesis images of the breast for breast cancer diagnosis; and the GE Healthcare SenoClaire, which uses a combination of 2D mammogram images and 3D breast tomosynthesis images.

Other technologies, which are under development, include 3D breast tomosynthesis, which artificially creates 3D images of the breast from a limited set of 2D images. Tomosynthesis reveals sections of the breast that can be hidden by overlapping tissue in a standard mammogram.

“The problem of overlapping shadows has confounded breast cancer screening because mammograms don’t show cancers that are hidden by overlapping tissue,” Myers says. And compounding the problem is overlapping tissue that can look like cancer but isn’t. “The new technologies we’re studying overcome these barriers,” she adds.

Another benefit of 3D breast tomosynthesis: It’s more accurate than mammography in pinpointing the size and location of cancer tumors in dense breast tissue, Myers says. With 3D breast tomosynthesis, doctors can detect abnormalities earlier and better see small tumors because the images are clearer and have greater contrast.

“Clinical studies have shown that 3D breast tomosynthesis can increase the cancer detection rate, reduce the number of women sent for biopsy who don’t have cancer, or achieve some balance of these two goals of this new screening technology,” she adds.