Lumicell, Inc. Selects BayCare for Pivotal Breast Cancer Clinical Trial

For many women with breast cancer, breast-conserving surgery is a critical first step in treatment. The goal is to remove all cancer cells while minimizing the removal of healthy tissue.

“Most breast centers treat with lumpectomy instead of mastectomy,” said Peter Blumencranz, M.D., breast surgeon, The Comprehensive Breast Center at BayCare’s Morton Plant Hospital. “They usually take out extra tissue, as best they can. The problem is with what you can’t see.”

Unfortunately, for 1 in 4 breast cancer patients, cancer cells are found at the margins of theremoved tissue, suggesting cancer cells may remain in the cavity, which typically requires patients to undergo a second surgery to remove the remaining cancer.

“Understandably, the patient is not happy,” Dr. Blumencranz said. “Additional surgery not only has a psychological effect on the patient, but it also delays the patient’s treatment and increases costs for the patient as well as the hospital.”

Dr. Blumencranz is participating in a pivotal clinical trial for the Lumicell Imaging System that could change that.

The Lumicell optical imaging technology provides real-time results during surgery. Prior to surgery, the patient is injected with a proprietary fluorescent solution that interacts with cancer cells. In the operating room, after the surgeon removes the visible cancerous tissue, the lights are turned off while the surgeon uses an optical scanner to shine a red light along the cavity margins to see if any cancer cells remain. A computer screen next to the surgeon gives an image that glows red where the fluorescence has interacted with cancer. “You can pretty quickly scan to see if you get a positive signal,” Dr. Blumencranz explained. “Then, you can go back and take another slice of tissue off the margin.”

Lumicell, Inc. completed a feasibility study of the technology and began the pivotal study in November 2019.  In the pivotal study, the technology will be used on 170 patients at up to 20 large academic centers and community breast cancer centers in the U.S. for intraoperative detection and removal of residual cancer in breast conserving surgery. BayCare’s Comprehensive Breast Center is the only center in Florida currently using the Lumicell Imaging System and one of the few in the country. “Our surgeries were put on hold for a while because of COVID-19 but we have resumed use of the imaging system,” Dr. Blumencranz said. “Lumicell reached out to us because we are well known and have a good research staff. Our clinical research coordinators make sure that every I is dotted and T is crossed.”

“This is an exciting moment for breast cancer patients and their physicians” said Barbara Smith, MD, PhD, lead investigator of the Lumicell breast cancer trials. Dr. Smith, director of the Breast Program at Massachusetts General Hospital and professor of Surgery at Harvard Medical School, also shared, “With this pivotal trial, the system gets an important step closer to FDA approval, but more importantly, patients and physicians are one step closer to having an innovative technology available for care.”

While Dr. Blumencranz is optimistic about the ability of the Lumicell Imaging System to treat breast cancer, he believes that early detection is key.  “Patients need to take care of themselves.”

Learn more about BayCare’s breast health resources at BayCare.org/services/breast-health.