Pegulicianine
A cavity-imaging dye used during breast lumpectomy to spot leftover tumour before the operation ends, reducing second surgeries.
INSITE trial (NEJM Evidence 2023): residual tumour found in 7.6% of patients after standard lumpectomy, avoiding some re-excisions (sensitivity 49%, specificity 86%). Approved April 2024 with the Lumicell direct visualisation system. Anaphylaxis risk noted.
- Medicare
- Part B (clinician-administered)
Intraoperative imaging agent for breast lumpectomy margin assessment, bundled into the surgical payment; hospital outpatient use had a pass-through payment code after approval.
- Commercial insurance
- variable
Bundled into the surgical claim; some plans consider it investigational.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Inpatient hospital care (Part A). Not medical or financial advice; verify with your plan.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: pegulicianine. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Fluorescence imaging in adults with breast cancer as an adjunct for intraoperative detection of residual cancer after lumpectomy |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Pegulicianine" OR ABSTRACT:"Pegulicianine" OR TITLE:"Lumisight" OR ABSTRACT:"Lumisight") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Pegulicianine, not a curated reading list.