New technology leads to comfortable mammogram alternative
New ultrasound technology developed in Detroit can potentially detect breast cancers masked by dense breast tissue more accurately than conventional ultrasound, and without the discomfort of a traditional mammogram.
Instead of compressing the breast between two plates and manipulating it to various viewing angles, the SoftVue technology has the patient lie on a table with the breast submerged in a reservoir of warm water. It takes less than two minutes to scan the whole breast, including the chest wall, without touching the patient.
“That mashing is horrible,” Detroit breast cancer survivor Velma Francine Dent said of the numerous traditional mammograms she’s endured. Dent, 67, said she felt only a gentle brush of water during a recent SoftVue ultrasound at Detroit’s Barbara Ann Karmanos Cancer Institute.
Detroit-based Delphinus Medical Technologies, co-founded by two Wayne State University professors at the Karmanos Institute, has received $39.5 million in venture capital to finance the manufacturing and marketing of the product. Neb Duric, a professor of oncology, and Peter Littrup, a professor of radiology and oncology, spent years developing the product.
Ultrasound is an accepted next step for a woman whose dense breast tissue could mask a tumor when traditional mammography is used. The new technology provides a more comprehensive image of the breast than hand-held ultrasound machines. And there is no exposure to radiation, as with a traditional mammogram.
The unique components of the technology — such as the circular transducer — have been cleared by the federal Food and Drug Administration.
Delphinus now is asking the FDA to indicate that SoftVue is appropriate for patients with dense breast tissue. A clinical trial is underway at Karmanos to collect data the federal agency requires to make the determination. A screen trial is set to take place soon at eight other institutions across the country.
Ultrasound creates images from sound waves that are too high-pitched to be heard by humans. Typically, the sound waves are sent by a hand-held device called a transducer that is passed across the surface of the breast. SoftVue uses a ring-like transducer that emits ultrasound signals in a sequenced, 360-degree circular array surrounding the breast as it floats in liquid.
“Ultrasound naturally sees masses better in dense breasts,” said Mark Forchette, Delphinus president and CEO.
“We see masses, but we also capture the sound signal as it goes through the tissue, and capture it on the other side so we can see the change in the sound speed. What that lets us do is not only see the mass, but we also are able to see the character of the mass: Is it a cancer, (benign) fibroadenoma or cyst? That’s a huge change.
“Ultimately,” he said. “if we’re able to reduce the number of unnecessary biopsies we’ve done a huge service.”
The new technology comes as 43 states, including Michigan, have passed laws requiring notification of women found during mammograms to have dense breast tissue, which can make it more difficult for a radiologist to spot a tumor, and may increase breast cancer risk.
Dense tissue can make tumors invisible on mammogram images, or indicate there are tumors when none exists.
Connecticut became the first state to enact a breast density law at the urging of a patient, Nancy Cappello, who was diagnosed with advanced-stage breast cancer in 2004. She had received normal mammography reports for more than a decade; her tumors had been masked by dense breast tissue.
Cappello later became the founder and executive director of Are You Dense Inc., a group that advocates nationwide for notification laws.
Women notified of dense breast tissue shouldn’t panic, experts say. A finding of dense breast tissue does not necessarily mean a woman will get cancer. According to the American Cancer Society, most cancers can be seen on mammograms, including those in women with dense breasts. So it’s important for women to continue to get mammograms even if they have dense breast tissue.
Even with a normal mammogram women should know how their breasts normally look and feel, so they can report any change to their physician.