New Michigan technique could better detect cancer in women with dense breast tissue

Women with dense breast tissue have a higher risk of cancer, in part because of an increased likelihood of missing suspicious lumps on digital mammography.

To better address this, the Barbara Ann Karmanos Cancer Institute in Detroit has pioneered the purchase of a new Michigan-developed system approved by the U.S. Food and Drug Administration to screen women whose breasts are denser than fatty tissue, This is a common disease. Conditions that complicate cancer detection.

It is a 3D whole breast ultrasound tomography system called SoftVue. For imaging, women lie flat on a horizontal platform with a hole in it. Their breasts fell into the warm bath one at a time. They are imaged using ultrasound and the sound itself.

The device automatically collects 3D tomographic images by moving a “sensor ring” vertically from the tip of the breast, reading the FDA’s description.

“This will be a life-saving measure,” said Dr. Natasha Robinette is a radiologist and director of clinical imaging services at the Cancer Center.

“The whole point of screening tools, whether it’s digital mammography or SoftVue, is to detect cancer early so women have a chance to get rid of it after treatment.”

Robinette said the system, used in combination with mammography, detected 20 percent more cancers than mammography alone, and had an 8 percent improvement in specificity, meaning fewer false positives.

“It’s better at detecting that there’s something there, but that’s nothing to worry about,” Robinette said.

That means fewer patients will have to return to medical centers unnecessarily, enduring panic and worrying that something may go wrong.

As now, in addition to a mammogram, women with dense breasts may need breast magnetic resonance imaging (MRI), which can be expensive and take about an hour, or a full-breast ultrasound. Ultrasound can be done automatically with mechanical compression or manually with a stick, as is done on a pregnant woman’s tummy.

As long as a process is manual, there’s a chance that something will be missed, and the SoftVue system doesn’t involve compression, which can be uncomfortable, Robinette said.

However, women may not always receive additional imaging. Patients typically receive a phone call or letter and must schedule a follow-up appointment for further testing as ordered by their doctor.

The FDA-approved SoftVue can be performed concurrently with a mammogram when breasts are thought or known to be dense, Robinette said. The test, which takes about 3 to 5 minutes per breast, for a total of about 10 minutes, is more of a private screening option “for those who may be self-conscious about their body image or expose themselves to medical procedures.” During the video presentation, the patient is always covered by the machine or gown.

“SoftVue images are intended to be interpreted in conjunction with mammography results to enhance screening,” reads the FDA-issued abstract, which identified no known contraindications or safety concerns.

It simplifies the process and produces images involving color that are easier for radiologists to read, Robinette said.

The FDA found possible risks to the SoftVue system in diagnostic accuracy, false positives and false negatives, but the agency determined that the benefits outweighed the risks.

The system has been in development for 10 years. Karmanos, part of McLaren Health Care in Grand-Blanc, launched Delphinus Medical Technologies in Novi, and they co-developed the device.

Delphinus President and CEO Mark J. Forchette in a statement.

Ongoing supply chain issues related to the pandemic could limit broad distribution, at least in the short term, but Robinette sees implementation elsewhere. Health systems in eastern and southern Michigan are considering SoftVue.

While there are 16 Karmanos sites, the SoftVue system will only be on the Detroit Cancer Center’s main campus, at least initially. Robinette said the device will be operational by the end of the year and will be operated by ultrasound technicians. She hopes to see it eventually offered at the Farmington Hills Breast Care Centre in Karmanos as well.

The goal of the study is to help about 40 percent of women with dense breast tissue, who are four times more likely to develop breast cancer.

In a mammogram, the more granular the breast tissue, the whiter the breast. Suspicious lumps are also white so they can be hidden.

Cancer doesn’t come from fatty tissue, but from granular tissue, so the more granular tissue, the higher the risk of cancer, Robinette said.

At this point, experts disagree on what other tests, if any, should be done, according to the American Cancer Society.

Letters to women with dense breasts are irregular. “And I think patients have been confused about, really, what does that mean you have dense breasts? And I think there’s been confusion about how to move forward,” Robinette said.

Some women may be missed. On the one hand, breast MRIs are reserved for people with other risk factors, such as close relatives with breast cancer or a previous diagnosis of ovarian or breast cancer.

The patient may not follow up, or the doctor may decide that further imaging is not required.

“It puts the lady in a bit of a bind, either they choose to do something extra, or they don’t, so they come back in another year for a mammogram.”

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