A Real-Time Cancer-Detecting System for Breast Cancer Goes Live

Breast cancer cells: © LASZLO- stock.adobe.com

The LumiSystem is now commercially available in the US for breast cancer detection. The device uses fluorescence imaging technology during lumpectomy, offering a more complete resection vs other detection systems that evaluate tissue after surgical removal in breast cancer.¹

The LumiSystem is a combination of 2 recently approved products, Lumisight and Lumicell Direct Visualization System (DVS). Lumisight is an optical imaging agent that fluoresces at sites of suspected cancerous tissue and Lumicell is an imaging device that provides real-time fluorescence guidance for scanning the breast cavity during lumpectomy surgery. The Lumisight system and Lumicell DVS are approved for use in combination to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the standard of care. ¹ The manufacturer, Lumicell, Inc is currently exploring the Lumisight system in other solid tumor indications.

“We breast surgeons know all too well the limitations of lumpectomy and the difficult conversations we have with patients about the possibility of a second surgery due to positive margins,” said Irene Wapnir, MD, professor of surgery at Stanford University School of Medicine and director of breast cancer surgical clinical research at the Stanford Cancer Institute both in California.

In the INSITE pivotal trial (NCT03686215), the LumiSystem improved surgical outcomes in 10% of patients with 84% diagnostic accuracy. In stages 0 to 3 of breast cancer, investigators assessed margin status with or without pegulicianine fluorescence-guided surgery.² Patients were randomly assigned 10:1 to pegulicianine fluorescence-guided surgery or control groups. Randomization was not designed to provide a control group for evaluating device performance, investigators noted. Of the total 406 patients enrolled in the trial, 392 patients were randomly assigned, with 316 having invasive cancers and 76 in situ cancers.

Of the 357 patients who underwent pegulicianine fluorescence-guided surgery, the procedure helped to remove remaining tumor tissue in 27 cases after a standard lumpectomy. This included 22 patients where the cavity was initially considered clear based on standard margin evaluation. Pegulicianine fluorescence-guided surgery also prevented the need for second surgeries in 9 of 62 patients with positive margins. When evaluating each margin individually, pegulicianine fluorescence-guided surgery had a specificity of 85.2% and a sensitivity of 49.3%.

Although the use of pegulicianine fluorescence-guided surgery did not meet the prespecified threshold for sensitivity, it met prespecified thresholds for removal of residual tumor and specificity, noted investigators.

Pegulicianine administration was halted in 6 patients due to adverse events (AEs) and 2 patients had grade 3 serious AEs that were related to pegulicianine administration.

In addition, anaphylaxis occurred in 0.6% of patients.¹ Those with a history of hypersensitivity AEs to pegulicianine, contrast media, or products containing polyethylene glycol should be identified prior to use and monitored. If a hypersensitivity AE is suspected, pegulicianine injection should be immediately discontinued and appropriate therapy should be initiated.

“Stanford is excited to adopt LumiSystem because, with its real-time fluorescence guidance, we are now able to detect and remove more cancerous tissue during surgery while still sparing as much healthy breast tissue as possible,” Wapnir stated.

References

1. Lumicell announces U.S. launch and first commercial use of LumiSystem™, pioneering real-time detection of residual breast cancer during lumpectomy. News Release. January 27, 2025. Accessed January 27, 2025. https://tinyurl.com/ztpux7c4

2. Smith BL, Hunt KK, Carr D, et al. Intraoperative fluorescence guidance for breast cancer lumpectomy surgery. NEJM Evidence. 2023;2(7). doi10.1056/evidoa2200333