Lumisight
Evidence Grade A — Regulatory approved. 5 published studies. 2 registered clinical trials.
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Pegulicianine (sold as Lumisight) is an imaging agent injected before breast cancer lumpectomy surgery that makes residual cancer tissue glow under a special camera. It is the first fluorescence imaging agent designed specifically for breast cancer surgery. By helping surgeons see and remove cancer that might otherwise be left behind, it can reduce the need for a second operation — which currently happens in about 1 in 5 lumpectomy patients.
5 published studies: 3 human, 0 animal, 0 in-vitro, 1 reviews
Pegulicianine is marketed as Lumisight (approved January 2025) as an adjunct for detection of residual cancer during breast-conserving surgery (lumpectomy). It is given as an intravenous infusion 2–6 hours before surgery.
In the INSITE trial, the rate of positive surgical margins (cancer left at the edge of removed tissue) was reduced from 9.6% to 3.6% when surgeons used pegulicianine fluorescence guidance. Positive margins typically require a second surgery, so reducing them has direct clinical impact. The technology represents a new approach to surgical oncology — using the tumour's own metabolic characteristics to make it visible in real time during the operation.
Cancer cells have abnormal metabolism that makes their surrounding environment more acidic than normal tissue (pH 6.2–6.8 versus 7.4). Pegulicianine exploits this difference: at normal body pH, the fluorescent dye component is chemically silenced. When it encounters the acidic environment around tumour tissue, the dye undergoes a chemical change that switches on its near-infrared fluorescence. Surgeons using a specialised camera can then see the cancer tissue glowing, guiding them to remove residual disease that is invisible to the naked eye.
In the Phase III INSITE trial, pegulicianine-guided surgery reduced the rate of cancer left at surgical margins from 17% to about 15% — with 9 patients who would have needed a second surgery being spared that procedure. The specificity (ability to correctly identify non-cancerous tissue) was 85%, though sensitivity (ability to detect all cancer) was moderate at 49%. Overall, the system improved outcomes in about 10% of patients treated. The technology exploits a fundamental difference between cancer and normal tissue: the acidic environment around tumour cells activates the fluorescent dye, while it remains dark in healthy tissue. Serious allergic reactions including anaphylaxis occurred in 0.6% of patients. The manufacturer is exploring use in other solid tumours including head and neck cancers and sarcoma.
Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques
The Impact of Surgeon-Interpreted Intraoperative Margin Assessment During Breast Conserving Surgery on Postoperative Treatment
FDA ORIG 1
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