Imaging Agent May Help Detect Breast Cancer Tumors During Surgery


Barbara Smith, MD, PhD, spoke about the potential use of pegulicianine-guided breast cancer surgery based on reports from the phase 3 INSITE trial.

After more than 10 years of work to improve breast cancer detection during surgery, Barbara Smith, MD, PhD, said she hopes to see an FDA approval of pegulicianine (Lumisight) in combination with the LumicellTM Direct Visualization System for this population.

During the Society of Surgical Oncology 2024 Annual Meeting (SSO), Smith, the director of the Breast Program and co-director of the Women’s Cancers Program at Massachusetts General Hospital, and professor of surgery at Harvard Medical School, spoke with CancerNetwork® about the potential utility of fluorescence-guided breast cancer surgery with pegulicianine in the context of findings from the phase 3 INSITE trial (NCT03686215).1 Data from this study highlighted that a portion of patients with breast cancer avoided a second surgery following the use of a pegulicianine-guided operation.

Despite these findings, Smith said that the field of fluorescence-guided surgery is in its early days and that it may take years for such tools to be implemented into routine practice.

The FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) voted in support of pegulicianine-based imaging in patients with breast cancer undergoing breast-conserving surgery in March 2024.2


This is an agent that may work for many types of cancer. The way we use it for breast surgery is that we [first] do our standard lumpectomy surgery. This dye will show fluorescence in areas of the lumpectomy cavity where there might be residual cancer. That allows the surgeon to see that spot, cut it out, and then look again to see that you’ve removed that abnormality. We’ve done a series of studies with this, most recently of 406 patients studied at 14 sites across the United States. This was the pivotal study that’s being used to put this system forward for FDA approval. It showed us that it could find a tumor that was left behind by standard surgery. It could take some patients who would have had positive margins and needed to have a second operation to go back, clear the tumor out, and get clean margins on the first try. Approximately 10% of patients who were in the study had one of those concrete benefits of having this extra fluorescence-guided surgery.

This field is in its early days. The agent we’re using, the Lumicell Direct Visualization System with a dye called [pegulicianine], we hope is going to be approved by the FDA next month. It’s been more than 10 years of work to get here. Some image-guided surgery techniques use standard agents, such as indocyanine green, which has been used in other types of surgery to detect blood flow. There are some tumors in which that’s applicable. We’re just beginning to see what this can do and to apply it more broadly. But we’re probably years away from it being used in routine [practice].


  1. Smith BL, Hunt KK, Carr D, et al. Intraoperative fluorescence guidance for breast cancer lumpectomy surgery. NEJM Evid. 2023;2(7). doi:10.1056/EVIDoa2200333
  2. Lumicell announces FDA Advisory Committee’s positive recommendation on the benefit-risk profile of LUMISIGHT™ in the detection of cancerous tissue during breast conserving surgery. News release. Lumicell Inc. March 6, 2024. Accessed March 25, 2024.
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