Canan Dagdeviren has dedicated her career to creating tools that can capture data from every nook and cranny of the human body. An electrode that reads brain signals in Parkinson’s patients. A tattoo-like patch to detect skin cancer. And now, a bra containing a flexible ultrasound that could one day be used to more comfortably screen for breast cancer.
On Friday, Dagdeviren and her colleagues at the Massachusetts Institute of Technology published new research on the ultrasound device that will form the basis of a company. It’s the first time the professor has tried to take her work out of the lab and directly to patients.
“I’m hoping to really make it real, and to touch people’s lives,” Dagdeviren said. “I want to see the impact of my technology not only in the lab, but on society.”
The device is still a long way from being used in the real world. Dagdeviren has tested it in just one patient so far, and has not proved its ability to distinguish between cancer and benign lumps. But if the device performs well in trials, she hopes it could become a cheaper and easier screening option that could save lives.
The device is a flexible patch that attaches to a bra via magnets, touching the skin through carefully placed holes in the bra. The ultrasound scanner is miniature, and can be rotated to image the entire breast. In the research published Friday in Science Advances, Dagdeviren’s team showed that the bra successfully identified tiny breast cysts in a 71-year-old woman with a history of such masses, and could image tissue as deep as 8 centimeters into the breast. The resolution resembled that of a traditional ultrasound.
Dagdeviren began brainstorming how to build a wearable ultrasound eight years ago while visiting her aunt, who was dying of breast cancer, in the Netherlands. She had been diagnosed with late-stage cancer at age 39, despite receiving regular mammograms, and died only six months later. The experience motivated Dagdeviren to start working on a cheaper technology that could be worn at home, enabling earlier cancer detection for high-risk women. Doctors could prescribe the device, which would be delivered to patients’ front doors.
“I still have the sketch of an electronic bra which can allow imaging at home rather than going to the hospital,” Dagdeviren said. “Many women have barriers to this kind of technology because of economical reasons, emotional reasons, or not having available resources.”
About 42,000 women die each year from breast cancer in the United States. The U.S. Preventive Services Task Force recommends women begin screening for breast cancer at age 40 with mammograms every other year. But it’s difficult to create a one-size-fits-all approach for people with different bodies and risk levels. Women with dense breasts might opt for supplemental ultrasound or MRI screenings, as mammography can sometimes miss deeper lesions difficult to see through dense tissue. Black women have a greater risk of dying due to early-onset breast cancer, and may want to test earlier and often.
Maimah Karmo, a breast cancer survivor and CEO of the Tigerlily Foundation, said she sees promise in Dagdeviren’s device helping underserved populations cross breast screening barriers.
“The benefit to people who are higher risk, like young Black women, is that they would have a tool that could better monitor them between mammograms, or even if they don’t have access to mammography,” Karmo said.
Maxine Jochelson, a radiologist at Memorial Sloan Kettering who is not involved with the device, agreed that a wearable ultrasound could be a game-changer for people who live in rural areas and must travel long distances to receive medical imaging.
Still, the device has a lot to prove when it comes to catching cancer early. Detecting lumps is not the same as detecting cancer. Jochelson said she wants to see data on the accuracy and specificity of the ultrasound.
“Women have lumps and bumps and all this stuff that comes and goes with their periods, and ultrasound is picking this stuff up,” Jochelson said. “Then you have to differentiate which one needs the biopsy and which one doesn’t.”
Ultrasounds are cheaper than mammograms and do not expose people to radiation, but Jochelson noted that mammography remains the gold standard and would likely always be necessary. She also said she’s worried that if the device is overly sensitive and unspecific, it could lead to false positive test results, unnecessary biopsies, and a general increase in anxiety.
“It could be that this is a great tool, but I am concerned that a woman who wants to examine her breasts every single day, and is an anxious person, is going to be running in and making herself crazy,” Jochelson said.
Roozbeh Ghaffari, a biomedical engineer at Northwestern who was not involved with the study, said it will likely be difficult for the ultrasound to distinguish between different types of tumors on its own. Dagdeviren might explore including other types of sensing technologies in the bra in the future, he said.
“Maybe you could image, but also characterize the material properties or the thermal properties of that tumor and then determine if it has certain signatures of a cancerous lesion versus one that is benign,” Ghaffari said.
Dagdeviren’s ultrasound will have to face the same test as every other diagnostic on the market: Do the benefits of early detection outweigh the harms of overtreatment?
“We have to do the homework with this type of ultrasound to see if the anxiety that we generate will help us save lives,” Jochelson said.
Dagdeviren understands those concerns, and is working on recruiting a diverse group of patients to test how well the device distinguishes between cancerous and benign lumps, as well as its false positive and negative rates. She will need to test hundreds before getting FDA approval. She also hopes to collect enough data to train an artificial intelligence algorithm that can be used with the wearable and reduce the false positive rate.
To do all of that, Dagdeviren is focused on attracting investors beyond a foundation grant that she can’t disclose, and on streamlining the manufacturing process. Morphing brittle electronic materials into a flexible ultrasound at scale is no easy feat. Dagdeviren wants most of all to help people like her aunt; to save lives before their cancer unfurls. But she couldn’t help but think of herself and other grieving loved ones, too, as people who may benefit.
“This technology will not only help people who are high risk, but also the people around them,” Dagdeviren said.