Pioneering Technology Enables Real-Time Detection of Residual Breast Cancer During Lumpectomy

Breast cancer is the most frequently diagnosed cancer in women, with lumpectomies being the most common treatment approach. About 65% of women diagnosed with breast cancer undergo a lumpectomy, also referred to as breast-conserving surgery, in which the tumor and a small margin of surrounding tissue are removed. This tissue is then sent to pathology for analysis, which often results in a waiting period of several days or even weeks before determining whether further surgery is required. While lumpectomies save lives by removing as much cancer as possible while preserving healthy breast tissue, up to 36% of patients may require a second surgery due to undetected residual cancer. This can lead to increased anxiety, additional costs, delays in receiving adjuvant therapies, and potential negative impacts on cosmetic outcomes. Now, a pioneering fluorescence-guided imaging technology for breast cancer detection helps surgeons identify residual cancer that may otherwise be missed, enabling more thorough tumor removal.

Lumicell (Newton, MA, USA) has announced the U.S. commercial availability of the LumiSystem, which combines two FDA-approved products: LUMISIGHT, an optical imaging agent that fluoresces at sites of suspected cancerous tissue, and the Lumicell Direct Visualization System (DVS), an imaging device that provides real-time fluorescence guidance during lumpectomy surgeries. LUMISIGHT and Lumicell DVS work together by harnessing the body's immune response to solid tumors, such as those in breast cancer. LUMISIGHT (pegulicianine) is injected into the patient before surgery and, within two hours, becomes activated by enzymatic activity in and around the cancerous tissue. Once the surgeon removes the primary tumor and completes the standard procedure, the Lumicell DVS handheld probe is used to scan the breast cavity for any remaining cancer cells.

In real-time, images are captured from within the breast cavity, processed, and interpreted by LumiSystem’s patient-calibrated cancer detection software. If the software detects regions that are suspicious for remaining cancer, these areas are highlighted on the screen for the surgeon’s attention. This real-time feedback enables the surgeon to pinpoint additional tissue that needs to be removed. Unlike traditional detection methods, which only assess tissue after it has been surgically removed, LumiSystem allows surgeons to visualize cancer directly within the breast during surgery. This capability significantly enhances the likelihood of achieving a more complete resection and reduces the need for follow-up procedures. In the INSITE pivotal trial, LumiSystem demonstrated an 84% diagnostic accuracy rate, improving surgical outcomes in 10% of patients treated. By identifying cancerous tissue that may have been completely missed by surgeons and pathologists, LumiSystem offers a more thorough approach to breast-conserving surgery and ultimately improves patient care.

"Today, with LumiSystem's commercial launch, we empower surgeons with a groundbreaking tool that detects cancer where and when it matters most, inside the breast cavity and in real-time," said Howard Hechler, CEO of Lumicell. "This launch reflects Lumicell's unwavering commitment to enhancing surgical outcomes for patients."

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