We think there is a real role for our device and that it could really transform breast cancer surgery once our trial is finished and hopefully shows the results that we’re anticipating.Richard J. Barth, Jr., MD
Many people who are diagnosed with breast cancer often have surgery to remove the tumor from the breast, called a “lumpectomy,” as part of their treatment plan. A lumpectomy is known as breast-conserving surgery because it allows the patient to keep her breast. The goal is to remove 100% of the tumor, without taking any extra healthy breast tissue. This is called “negative margins.” However, around 25% of the time, cancer cells that surgeons can’t see remain around the very edge of the tumor. This results in patients having to come back for a second surgery to remove the remaining cancer cells and achieve negative margins.
Seeing an obvious problem, Dartmouth Cancer Center breast surgeon, Richard J. Barth, Jr., MD, set out to lessen the chances that breast cancer patients would need to come back for a second surgery.
Barth’s first innovation was to obtain an MRI image with patients lying on their backs, so the breast is positioned the same way it would be on the operating table. He then turned to the expertise of engineers from Dartmouth’s Thayer School of Engineering, to create a 3D image of the cancer in the breast that the surgeon can use for visualization. From there, Barth’s team engineered the second part of the solution, called the Breast Cancer Locator (BCL).
The BCL is a plastic mold of the breast that is custom 3D-printed for each patient. The BCL is placed on the patient just before surgery. The holes in the mold allow the surgeon to place wires into the breast around the exact edges of the tumor.
The pilot trial of the BCL went very well. “Of 19 patients, we showed that the Breast Cancer Locator very accurately identified the cancer and allowed us to resect it with negative margins in all 19 patients,” says Barth. The success prompted his team to form biotech startup CairnSurgical, Inc. to further develop the BCL, which they have done over the past several years. In a second pilot trial, Barth’s team involved three other hospitals to show that surgeons at other institutions could also use the BCL very effectively.
The success of these trials led Barth’s team to initiate a large pivotal trial. “In our pivotal trial, we’re comparing our new wire localization guidance system—the Breast Cancer Locator and the 3D image visualizer—to the ‘standard of care,’ which is just having a wire placed in the middle of the tumor prior to surgery,” explains Barth, who also notes that the vast majority of patients who hear about the pivotal trial are interested in participating.
One of those patients was Ellie Tallon. “I was comforted that I had an opportunity to be part of this trial that would help the chances of not having a second surgery, which I didn’t have to have,” says Ellie. “I was excited to be part of something that could really benefit other people down the road.”
The technology is now in clinical trials at cancer centers around the U.S., including community hospitals right here in the northeast. “We think there is a real role for our device and that it could really transform breast cancer surgery once our trial is finished and hopefully shows the results that we’re anticipating,” says Barth.
See and hear more about the innovation of the Breast Cancer Locator in this video.