Cancer Research:Breast cancer detection rate using ultrasound is shown to be comparable to mammography ♦ New method for better treatment of breast cancer ♦ New target for potential blood cancer treatment

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Detecting more small cancers in screening mammography suggests overdiagnosis Screening mammography was associated with increased diagnosis of small cancers in a study across U.S. counties but not with significant changes in breast cancer deaths or a decreased incidence of larger breast cancers, which researchers suggest may be the result of overdiagnosis.

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Mammography: What You Need to Know

On this page:

• How Does the Test Work—and Is It Painful?
• Why Is Facility Certification Important?
• What Is the Difference Between 3D and
• 2D Mammograms?

Dr. David Lerner, FDA medical officer in the Division of Mammography Quality Standards, discusses the importance of mammography and encourages viewers to speak with their healthcare providers about a breast cancer screening schedule and tools most appropriate for them.

Did you know that mammograms are still the best tool for breast cancer screening? It’s true, and the U.S. Food and Drug Administration (FDA) certifies facilities that perform mammography —and clears and approves new mammography devices—to help keep you safe.

How Does the Test Work—and Is It Painful?

A mammogram is a low-dose X-ray picture of the breast. Getting a mammogram is the best way to find breast cancer early, because it can show breast lumps when they are too small for you or your healthcare provider to feel them.

Thermograms and nipple aspirate tests are not substitutes for mammograms. You should ask your healthcare provider when and how often you should schedule a mammogram, says Helen J. Barr, M.D., director of the Division of Mammography Quality Standards in FDA’s Center for Devices and Radiological Health (CDRH). ”Regular screening mammograms are important,” she adds.

To get a mammogram, you will need to take off your shirt and bra. While standing in front of the machine, a technologist will position your breast on a small platform. A clear plastic plate will press down on your breast while the mammogram is acquired.

If you’re worried about how the procedure feels, you should know that most women do not find it painful. Some women may find the pressure on the breast uncomfortable, but it lasts for only a few seconds. “Compression of the breast is important because it helps spread out the breast tissue so it doesn’t overlap, allowing better visualization,” explains Barr.

FDA regulations require that you (the patient) receive a summary of the mammography report within 30 days after your mammogram, and that reasonable attempts to communicate the results are made sooner if the results are suspicious or highly suggestive of malignancy. If you do not receive the mammography report summary, call your provider to get your results.

As a rule, you should also call your healthcare provider if you notice any change in either of your breasts. A lump, thickening or nipple leakage, or changes in how the nipple looks can signal a potential problem.

Why Is Facility Certification Important?

FDA, or an FDA-approved state certifying agency, certifies mammogram facilities in the United States under a law called the Mammography Quality Standards Act (MQSA). The Act’s purpose is to ensure that facilities and their staff are producing quality mammograms.

“Certification is important because it indicates that a facility has met the MQSA requirements for practicing quality mammography. And a high-quality mammogram can help detect breast cancer in its earliest, most treatable stages,” says Barr.

Each mammography facility is inspected every year. During the inspection, a trained evaluator checks the facility’s equipment, staff training, and staff qualifications. Each facility also undergoes an in-depth accreditation process every three years.

To legally perform mammography, facilities must be certified. “There is a certificate that shows that the facility has been certified,” notes Barr. “Consumers should look for that certificate, which should be prominently displayed.”

What Is the Difference Between 3D and 2D Mammograms?

In recent years, FDA has approved advanced mammography devices that perform 3D digital breast tomosynthesis, a technology that creates cross-sectional (3D) images of the breast from X-rays taken from multiple angles. These devices provide informative images of the breast tissue and are helpful in evaluating dense breast tissue. “Dense breast tissue can make cancers more difficult to find on a mammogram,” says Barr.

After conducting premarket reviews, FDA determined that there was a reasonable assurance that the new 3D devices were safe and effective for their intended use. New breast-imaging equipment must receive an FDA approval or clearance before being marketed, says Robert Ochs, Ph.D., chief of FDA’s Mammography, Ultrasound, and Imaging Software Branch at CDRH.

“FDA’s approval of 3D mammography devices was based on a review of clinical studies involving multiple radiologists and hundreds of cases,” says Ochs. “FDA also sought input on the safety and effectiveness of the devices from a panel of non-FDA clinical and technical experts.

You can ask your doctor if 3D mammography or additional 3D imaging methods, such as ultrasound or MRI, are options for you. Ochs adds: “The results from multiple studies show that the combination of 3D and 2D imaging can improve breast cancer screening for all women.”

About 8,600 certified facilities are now in operation across the country. To find a mammography facility in your area, you can search the list on FDA’s website by your zip code. The list is updated weekly.

3D Technologies Poised to Change How Doctors Diagnose Cancers

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.

They are 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.

The technologies 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.

There’s also a lot of research and development in 3D ultrasound, which automatically scans the breast and generates 3D data that can be sliced and examined from any direction. Garra, who is a leader in this field, says 3D ultrasound improves breast cancer detection in women with dense breast tissue.

“Both 3D breast tomosynthesis and 3D ultrasound detect breast cancer. But for radiologists and other doctors, there are many more images to examine, and that can reduce the speed at which studies can be interpreted,” he says.

Another promising technology—the dedicated breast CT system—creates a full 3D representation of the breast. The scan is taken while the patient lies face down on a bed with her breast suspended through a cup and the X-ray machine rotates around it. For patients, the procedure is more comfortable than regular mammography because the breast isn’t compressed. Also, there’s less radiation exposure than during a CT exam of the entire chest because only the breast is exposed to X-rays.

Health care practitioners using this technology have to learn how to read and interpret hundreds of high-resolution images produced by the scanner. But what makes the task easier is that the images have less distortion than mammography, and the system is optimized to differentiate between the breast’s soft tissue and cancer tissue.

“These images will be very different from 2D mammograms. They’re truly 3D images of the breast from any orientation. You can scroll through the slices—up and down, left and right—and get a unique view of the breast like never before,” Myers says. “It gives doctors tremendous freedom in how they look at the interior of the breast and evaluate its structures. It’s almost like seeing the anatomy itself.”

New Era in How We See

How can radiologists look at these images and convert them into three dimensions? That’s where Badano’s work comes in. His research lab is exploring various display device technologies to improve how radiologists review 3D images. The studied technologies include devices supported by mobile technologies and special-purpose 3D displays developed specifically for 3D imaging systems.

“These are no longer conventional images, so you need to examine them in the 3D space,” he says. “Using a 2D display might no longer be ideal.” Device manufacturers are building on technologies developed primarily for other markets, including the gaming industry, to show 3D images in actual 3D. But the work is painstaking and far from ready for a medical use.

“As people have experienced in movie theaters and when playing videogames, 3D displays have problems, including the image resolution and added noise. When wearing 3D glasses, our brain needs to separate the images from the left eye and the right eye and reconstruct a 3D object,” Badano says. “In the lab, we’re doing experiments to see how different technologies handle these tradeoffs.”

One of the challenges is that 3D displays for medical imaging require better resolution. For a medical use, the specifications are high—“and so are the stakes,” he adds.