{"entity":{"id":"pegulicianine","kind":"drug","name":"Pegulicianine","aka":[],"tldr":"A cavity-imaging dye used during breast lumpectomy to spot leftover tumour before the operation ends, reducing second surgeries.","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 sensitivity of 49% and specificity of 86%, and some re-excisions were avoided. 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.","status":"approved","asOf":"2026-09-24","wikipedia":"https://en.wikipedia.org/wiki/Pegulicianine","links":[{"label":"INSITE (NEJM Evidence 2023)","url":"https://doi.org/10.1056/EVIDoa2200333"},{"label":"ClinicalTrials.gov NCT03686215","url":"https://clinicaltrials.gov/study/NCT03686215"}],"tags":["gap-fill","diagnostic"],"related":[],"cancers":["breast-hr-positive","tnbc","breast-her2-positive"],"sections":[],"technologies":["fluorescence-guided-surgery","optical-imaging"],"targets":[],"drugs":[],"companies":["lumicell"],"institutions":[],"pathways":[],"terms":[],"trials":["insite"],"people":[],"bottlenecks":[],"keyPapers":["paper-smith-nejm-evid"],"journals":[],"dependsOn":[],"notes":[],"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":[{"region":"US","year":2024,"indication":"Fluorescence imaging in adults with breast cancer as an adjunct for intraoperative detection of residual cancer after lumpectomy"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/pegulicianine/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"fluorescence-guided-surgery","kind":"technology","name":"Fluorescence-guided surgery","route":"/technologies/fluorescence-guided-surgery/"},{"id":"intraoperative-fluorescence-imaging-systems","kind":"technology","name":"Intraoperative fluorescence and Cerenkov imaging systems (SPY, Firefly, LumiSystem, LightPath)","route":"/technologies/intraoperative-fluorescence-imaging-systems/"},{"id":"optical-imaging","kind":"technology","name":"Optical & fluorescence imaging","route":"/technologies/optical-imaging/"}],"company":[{"id":"lumicell","kind":"company","name":"Lumicell","route":"/companies/lumicell/"}],"trial":[{"id":"insite","kind":"trial","name":"INSITE","route":"/trials/insite/"}],"paper":[{"id":"paper-smith-nejm-evid","kind":"paper","name":"Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery","route":"/key-papers/paper-smith-nejm-evid/"}]}}