# Pegulicianine

Source: https://onco.cc/drugs/pegulicianine/  
OnCo record `pegulicianine` (Imaging agent). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A cavity-imaging dye used during breast lumpectomy to spot leftover tumour before the operation ends; in its main trial it spared a second operation for 9 of 62 patients whose margins were positive.

## Summary

Pegulicianine is a PEGylated, quenched fluorescent dye that is cleaved by cathepsins and matrix metalloproteinases abundant in tumour and tumour-associated cells. When the lumpectomy cavity is scanned with the Lumicell direct visualisation system after standard excision, activated dye reveals residual cancer so the surgeon can remove it before closing. In the INSITE trial (NEJM Evidence 2023) residual tumour was found in 7.6% of patients after standard lumpectomy, with a per-margin sensitivity of 49.3% and specificity of 85.2%; the trial met its thresholds for removing residual tumour and for specificity but not for sensitivity, and second surgeries were avoided in 9 of 62 patients with positive margins. The FDA approved it in April 2024 as an adjunct for intraoperative detection of residual breast cancer; anaphylaxis is a recognised risk. Its modest sensitivity means it complements rather than replaces margin pathology. Pegulicianine aims to reduce the second operations that follow many breast-conserving surgeries.

## Fields

- Kind: Imaging agent
- Status: approved
- Last checked: 2026-09-24
- Tags: gap-fill; diagnostic; precision
- Brand: Lumisight
- Modality: Protease-activated fluorescent imaging agent
- Mechanism: PEGylated quenched dye cleaved by cathepsins and MMPs abundant in tumour and tumour-associated cells, fluorescing in the lumpectomy cavity to reveal residual cancer.
- Approvals: US 2024: Fluorescence imaging in adults with breast cancer as an adjunct for intraoperative detection of residual cancer after lumpectomy

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Pegulicianine
- INSITE (NEJM Evidence 2023): https://doi.org/10.1056/EVIDoa2200333
- ClinicalTrials.gov NCT03686215: https://clinicaltrials.gov/study/NCT03686215

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Fluorescence-guided surgery](https://onco.cc/technologies/fluorescence-guided-surgery/), [Intraoperative fluorescence and Cerenkov imaging systems (SPY, Firefly, LumiSystem, LightPath)](https://onco.cc/technologies/intraoperative-fluorescence-imaging-systems/), [Intraoperative margin assessment in breast-conserving surgery](https://onco.cc/technologies/intraoperative-margin-assessment-breast/), [Optical & fluorescence imaging](https://onco.cc/technologies/optical-imaging/)
- companies: [Lumicell](https://onco.cc/companies/lumicell/)
- trials: [INSITE](https://onco.cc/trials/insite/)
- key papers: [Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery](https://onco.cc/key-papers/paper-smith-nejm-evid/)
- roadmaps: [Precision roadmap: margins measured in millimetres → tests that find a target → doses fitted to the person → precision that changes outcomes](https://onco.cc/roadmaps/precision-roadmap/)

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