Research teams devise a 3D alternative to mammography

Neb Duric, PhD, professor of radiation oncology, Wayne State University, and imaging program leader, the Barbara Ann Karmanos Cancer Institute.

After reporting on the cancer death of a colleague, Good Morning America anchor Robin Roberts discovered a lump in her own breast. Roberts, 46, had a traditional mammogram, but it failed to detect any cancer. A follow-up test using ultrasound imaging found the mass and Roberts underwent surgery to remove the cancer, and her prognosis is good.

When it comes to screening for breast cancer, mammograms are still the method of choice. But scientists at the Barbara Ann Karmanos Cancer Institute, affiliated with Wayne State University, Detroit, are working to change that. They say that a three-dimensional ultrasound device they have developed could offer a cheaper and safer alternative to the mammogram, reducing unnecessary biopsies and eliminating radiation from the screening process.

The institute, whose physicians and scientists also teach at Wayne State, has been working on a breast imaging tool it calls the Computerized Ultrasound Risk Evaluation (CURE) for the last decade, and received a $1.6 million grant from the Michigan Economic Development Corp last year to complete analysis of the device. The product is unique in that it delivers data for two different purposes. One application for the data is a risk assessment that measures breast tissue density, and the other component is diagnostic, aimed at finding tumors.

A team of scientists from Karmanos and Wayne State presented findings from a clinical trial with 100 patients using the device at the annual meeting of the American Association of Physicists in Medicine in July.

Analyzing Unlike Mammography

Using three-dimensional ultrasound tomography, the CURE machine is able to analyze the density of a patient’s breast tissue in a way that the mammogram can’t. With this alternate form of ultrasound tomography, the patient lies in the prone position with a breast projecting down into a small pool of water. The breast is surrounded by a ring-shaped transducer for sending sound waves into the breast through sensors from all sides. The resulting ultrasound detection captures both reflected and transmitted sound waves. From this, an ultrasound percent density can be determined.

Possible applications for the device include breast cancer detection as well as screening for breast tissue density, said Neb Duric, PhD, professor of radiation oncology at Wayne State University and imaging program leader at the Karmanos Cancer Institute. High amounts of dense breast tissue—as opposed to fatty breast tissue—are associated with increased risk of breast cancer.

As for treating cancer once it is found, the project is exploring the use of high-intensity focused ultrasound (HIFU) and a technique known as “time reversal,” a physical phenomenon that allows more accurate focusing of ultrasound energy to destroy tumors. Cancer treatment is something Karmanos is interested in pursuing, but the immediate goal with the CURE device is more focused on measuring density and discovering trouble spots. And researchers believe ultrasound is the way to do that.

“There are a lot of women out there with dense breast tissue who don’t know it, who aren’t served by mammography,” said Duric. “Mammography has a hard time with dense tissues where the false-negative rate can be 50%. That’s a real problem because you’re missing half the cancers.”

Mammography Under 40

Currently, x-ray mammograms aren’t recommended for patients under 40 because of the risk of excessive radiation over years of screening. A radiation-free technology would eliminate that risk.

Another problem with mammography, Duric said, is that it compresses the breast onto a plane, which, aside from being uncomfortable, limits the level of detail that can be seen. The ultrasound technology provides a 3D view that allows the clinician to pinpoint more specifically areas of dense tissue. Overall, Karmanos’ imaging concept is not better at finding tumors than mammography, but it is superior in finding density, said Duric.

It’s also less expensive. Treatment rooms don’t need to be reinforced to contain the radiation. And ultrasound tomography’s ability to see the breast in greater detail could vastly reduce the need for expensive tissue biopsies—to the tune of $1 billion a year, said Duric.

Attempting to increase the role of ultrasound in breast cancer screening isn’t new. R. James Brenner, MD, JD, chief of breast imaging and professor of radiology at University of California-San Francisco/Mt Zion Hospital Cancer Center, San Francisco, said that studies and experiments in the 1980s placing breasts in water and bouncing sound waves off them to locate cancer and density were disappointing.

“The results were not very good, which quenched people’s desire to use that technique,” he said. “But they were using low-frequency transducers, so it’s possible that with high-resolution transducers, it may produce results that are better.”

Updated Technology

Duric confirms that the new generation of transducers being used to do the tests at Karmanos are indeed much higher quality. In addition, computing power has increased hundreds of times, he said, making the ultrasound techniques Karmanos is developing very different from the type of regular, free-hand ultrasound one would see at a prenatal examination.

With clinical trials ongoing at the institute—which sees about 6,000 cancer patients a year—the next phase for the CURE project is perfecting the device and designing a strategy to bring it to market.

Lothar Koob of Extera Partners, a Cambridge, Mass-based advisory firm focused on promising life science companies, is working with project managers at the Karmanos Institute to plan the commercialization of the CURE technology. He said the goal is to produce a prototype breast imaging machine that could be in clinical trials within 12 to 18 months and then shown to potential investors.

Once that is accomplished, the device would enter the Food and Drug Administration approval process, and Extera would begin looking for investors. “The results [of the trials] are encouraging, but to demonstrate the value, we need to expand in certain areas,” said Koob. “There is a lot of interest in the investment industry in medical devices; I think people are looking for interesting leads and CURE could be one of those.”

He said the fact that current imaging therapies produce so many unnecessary biopsies makes an alternative particularly attractive. “If we can reduce biopsies by 20% to 30%, it would be a significant success story.”

The relative cost-effectiveness of ultrasound imaging, compared with technologies like MRI, is also a huge selling point for investors. Third, the CURE device’s multipurpose capability means there is a potentially larger market for it.

Koob said the preferable avenue for commercialization of the CURE machine would be for Karmanos to work with an established equipment manufacturer to bring the product to market. That scenario would mean a rapid ramp-up, he said. Other options would be a sale or merger with a firm in the same market segment that is lacking that specific imaging know-how. And then there’s always the possibility of forming a new venture from the ground up.

At the moment, it’s too soon to say which direction the CURE project will take. Koob confirmed that he has had discussions with manufacturers about commercializing the device, but he declined to name names.

Roberts, the morning news anchor, is back at work and her prognosis is good. News of ultrasound successfully detecting cancer gives Karmanos researchers hope that their device will flourish.

Barbara Correa is a contributing writer for Axis Imaging News. For more information, contact