The FDA has approved Lumicell's Direct Visualization System (LumiSystem) for use in adults with breast cancer undergoing lumpectomy surgery. This innovative system allows surgeons to detect cancerous tissue in real-time within the resection cavity, potentially leading to more complete cancer removal during the initial surgery and reducing the need for repeat operations. The approval marks a significant advancement in breast cancer treatment, addressing the challenge of identifying microscopic tumor at lumpectomy edges during the initial procedure.
How LumiSystem Works
LumiSystem incorporates LUMIGHT, a novel fluorescent imaging agent, along with a handheld imaging device and software. Prior to surgery, LUMIGHT is administered intravenously. After the standard lumpectomy, surgeons use the LumiSystem to image the lumpectomy cavity intraoperatively. The system identifies areas of fluorescence, indicating potential residual tumor tissue, which can then be removed immediately.
Dr. Barbara L. Smith, Director of Massachusetts General Hospital’s Breast Program, explains, "We look right into the patient with light, with no trauma to breast tissue. And we’re actually getting a more thorough look than the pathologists can, since the device can examine the entire cavity in about a minute."
Clinical Trial Results
Clinical trials involving over 800 breast cancer patients demonstrated the effectiveness of LumiSystem. The system exhibited 84% diagnostic accuracy in identifying tumor tissue that would have been missed by standard surgical procedures. The pivotal trial results, published in NEJM Evidence, highlighted the potential for LumiSystem to improve cancer resection and reduce the need for secondary surgeries.
Impact on Patient Care
Approximately 20% of women undergoing lumpectomy require a second surgery due to positive margins, where cancer cells are found at the edge of the removed tissue. LumiSystem offers a solution to this problem by providing surgeons with real-time feedback during the initial surgery.
"During lumpectomy surgery, surgeons still struggle to identify and remove all of the tumor during the first operation," says Dr. Smith. "With LumiSystem, we now have a technology that can achieve a more complete cancer resection and help reduce the need for second surgeries."
Future Applications
Currently, LumiSystem is approved for use in breast cancer lumpectomies. However, research is underway to explore its potential application in other types of cancer. The system's ability to provide immediate visualization of tumor tissue could revolutionize surgical oncology, leading to improved outcomes for patients across various cancer types. Dr. Smith notes, "This system is a rational improvement over current week-long pathology assessment of excised tissue. It’s the first approved product that takes the approach of looking inside the surgical cavity where the tumor remains and allows immediate removal of residual tumor. We’re excited to see how this approach will improve patient care."
