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Detecting more cancer in 'dense breasts' with automated ultrasound screenings

A screenshot of a SonoCiné automated ultrasound.

Back in 2003, Nancy Cappello did what she had done annually for a decade — she went in for her yearly mammogram. And as usual, it came back normal.

But six weeks later, during a physical exam, her doctor felt something suspicious and ordered another mammogram and a diagnostic ultrasound. Again, the mammogram showed nothing. But the ultrasound spied a lump about the size of a quarter. It was cancerous and had spread to her lymph nodes.

"Thirteen lymph nodes were all cancer," she said. 

Several doctors told her the cancer had likely been growing for four to five years. Cappello was shocked. She wondered how it could have slipped undetected past her annual mammograms.

It was then her doctor told her that she has what are known as “dense breasts.”  The term refers to breasts with high levels of fibrous connective tissues. Those tissues appear white on a mammogram — just like cancer does. 

An estimated 40 percent of women have dense breasts. In recent years women have become more familiar with the term as states have passed laws requiring doctors to notify women in writing when mammograms show they have dense tissue. Cappello's own nonprofit has pushed for such laws — and so far, 28 states have them, including California.

But it's unclear what women do differently after receiving such a letter. A University of California, Davis study found that 10 months after the state's notification law took effect in April of 2013, doctors and their patients still weren't sure how to act on the information.

Dr. Barbara B. Hayden, a Santa Monica-based breast reconstruction surgeon, says women who receive a notification letter may not realize the limitations of standard mammograms or their alternatives.

"You don't realize that this is a warning letter," she said, "That you need additional screening and... mammography  isn't good enough for you and may not help you at all."

Hayden, too, had cancer that went undetected by a mammogram. She’s also a mother of two daughters with an elevated risk for breast cancer. Those factors, she said, motivated her to search for radiation-free screening methods that would be more effective than mammography in dense-breasted women.

She's learned over time that both MRIs and traditional ultrasounds are problematic alternatives. MRIs are typically used to detect breast cancer by injecting women with a contrasting dye — which some studies show may accumulate in the brain, causing harmful side effects

The traditional ultrasound also has limitations beyond its use as a diagnostic tool. Hayden said that’s because it relies on technicians who must split their attention between scanning the breast with a handheld device while also watching a screen in order to spot abnormalities. 

"It’s a bit of a random walk through the breast and involves the hand-eye coordination of the technician," she said. "It’s not even done by a radiologist most of the time.”

Something that works better, she said, is the SonoCiné. It’s an automated ultrasound machine that screens all of a woman’s breast tissue, because it's able to reach under the breast, into the armpits and up to the collarbone where breast tissue exists. 

Pasadena radiologist Dr. Kevin Kelly invented it and brought it to market 13 years ago.

"This was designed to make it as easy as possible to see a cancer," he said. 

His ultrasound machine — which has an FDA clearance as a supplement to mammography — is one of three automated ultrasound machines now on the market. GE Healthcare and Siemens have similar devices, but Kelly's is the only type that captures all the breast tissue — and it’s the only type that produces a mini-movie of the patient’s breast tissue, rather than a static image.

Video of a SonoCine breast movie

"We see things that move much better than we see things that don’t," Kelly said. "So it moves at a speed that [allows you] to see something that is 5 millimeters [wide].” 

That tiny size matters. He points to large study out of the Netherlands that shows women who had a tumor removed before it reached 10 millimeters had a comparable survival rate to women who never got cancer. 

Such high resolution can mean more false positives, and critics say that can result in unnecessary biopsies and lumpectomies. Hayden believes that when lumps as small as 5 millimeters are found, there’s no need to act right away because not all are, or will become, cancerous.

“Once you see it, [it] doesn’t mean you have to take a knife and cut it out," she said.

She believes patients can take a watch-and-wait approach, and do a follow-up scan a few months later. Since an ultrasound emits no radiation and has no known health risks, follow-up scans aren't considered harmful. A lump can be removed if another scan shows it has grown.

Studies suggest the technology is effective for supplemental screening needed by women with dense breasts, as well as those with implants. Still, Kelly's devices and the other automated ultrasound machines have barely cracked the U.S. market.

That could be, in part, because most insurance companies don’t pay for these screenings. Out-of-pocket, the SonoCiné costs women between $175 and $300, while mammograms are about $100 and are typically covered by insurance.   

What’s more, Hayden said, there’s been years of investment in mammograms nationwide, while generally speaking, medicine is slow to embrace change. Take preventative screening for cervical cancer as an example, she said.

 “How long was the pap smear around before people finally accepted it? A very long time. And it was poo-pooed for decades," she said, "During the time people said ... it would never work, many women died of cervical cancer."

Hayden's office recently became one of a dozen in California that offer Kelly's automated whole breast ultrasound machines.

CORRECTION: Due to an editing error, an earlier version of this story incorrectly stated that California dense breast notification passed in 2009. The law was passed in 2012 and took effect in April, 2013. KPCC regrets the error.