Surgeons at Stanford School of Medicine have become the first in the United States to use a new FDA-approved imaging technology that may lower the chances of needing a second surgery after a lumpectomy.
The technology, called LumiSystem, was approved by the U.S. Food and Drug Administration in 2024. It uses fluorescent dyes to highlight cancer cells that may still remain after a tumor is removed. This allows surgeons to detect and remove leftover cancer cells during the first operation.
Why LumiSystem Is a Big Step Forward
A lumpectomy is a common treatment for early-stage breast cancer. It removes the tumor but keeps as much healthy breast tissue as possible. After surgery, doctors send the tissue to the lab to check if cancer cells are present on the edges, also called the margins. But this process can take days and only looks at a small part of the tissue.
If cancer is found on the margins, patients often need a second surgery to remove more tissue.
“During a lumpectomy, we always try to remove the full tumor, but it’s hard to tell if the edges are clear while in the operating room,” said Dr. Irene Wapnir, professor of surgery at Stanford School of Medicine. She is also the lead investigator in the key study of this technology. “The LumiSystem lets us scan the surgical site right away to see if any cancer is left behind.”
How LumiSystem Works in the Operating Room
The LumiSystem includes a handheld endoscope that detects a glow from fluorescent dyes. These dyes react to specific enzymes found in cancer cells or nearby inflamed tissue. Surgeons inject the dye about two hours before surgery. Once the tumor is removed, they use the endoscope to scan the site for any glowing areas that might signal hidden cancer.
The entire scanning process only adds about five to seven minutes to the surgery time, according to Dr. Wapnir.
Promising Results from National Study
In a national clinical study of 357 breast cancer patients, the LumiSystem detected remaining cancer in 14.5% of cases where the surgical margins were positive. In some cases, it even found cancer that traditional lab testing missed.
Who Can Get This New Treatment?
Stanford is now offering the LumiSystem to qualified patients. It is mainly used for people with a single, untreated breast tumor. Dr. Wapnir said most patients are eager to try the system. However, the hospital is clear about what the technology can and cannot do. They are still testing it in more complicated cases.
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