# INSITE

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

## TL;DR

In the study behind Lumisight's approval, scanning the lumpectomy cavity with a fluorescent dye found cancer left behind by standard surgery in about one patient in thirteen and spared some women a second operation, with few false signals but a modest hit rate on individual margins.

## Summary

INSITE (NCT03686215; organisation id CL0007) was the Lumicell-sponsored prospective multicentre pivotal trial of pegulicianine fluorescence-guided surgery with the LUM Imaging System for residual cancer in the breast lumpectomy cavity, run with National Cancer Institute support at 14 US sites. Women with stage 0 to 3 breast cancer received 1.0 mg/kg intravenous pegulicianine before lumpectomy and were randomly assigned 10:1 to fluorescence-guided surgery or a control group; the randomisation existed to stop surgeons taking smaller than standard lumpectomies in anticipation of the imaging, not to provide a powered control arm for device performance. In the imaging group, additional cavity margins were excised wherever the dye signalled. The three coprimary endpoints were the percentage of patients whose guided margins contained cancer, per-margin sensitivity and per-margin specificity.

In the NEJM Evidence 2023 report, 406 patients received pegulicianine and 392 were randomised (316 invasive, 76 in situ cancers). Among 357 patients who had fluorescence-guided surgery, guided margins removed tumour left behind after standard lumpectomy in 27 (22 from cavity orientations that standard margin evaluation had called negative). Second surgeries were avoided in 9 of 62 patients with positive margins. Per-margin specificity was 85.2 percent and sensitivity 49.3 percent. Pegulicianine was stopped for adverse events in six patients, and two had grade 3 serious adverse events related to it. The trial met its prespecified thresholds for residual tumour removal and specificity but not for sensitivity.

The FDA approved pegulicianine (Lumisight) in April 2024 as an adjunct for intraoperative detection of residual cancer after lumpectomy. ClinicalTrials.gov lists the trial as a completed phase 3 with 406 participants, matching the paper's treated cohort.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-24
- Also known as: CL0007; Investigation of Novel Surgical Imaging for Tumor Excision; LUM Imaging System pivotal
- Registry id: NCT03686215
- Phase: 3
- Setting: Stage 0 to 3 breast cancer undergoing lumpectomy: intravenous pegulicianine 1.0 mg/kg followed by fluorescence imaging of the cavity with the LUM Imaging System after standard excision, with extra margins taken where the dye signals
- Sponsor: Lumicell
- Enrolled: 406
- Result: Residual cancer removed by guided margins in 27 of 357 patients; per-margin specificity 85.2% and sensitivity 49.3%; second surgery avoided in 9 of 62 patients with positive margins. Residual-tumour and specificity thresholds met, sensitivity threshold not met.
- Outcomes: Patients in whom fluorescence-guided margins removed residual cancer after standard lumpectomy: Pegulicianine fluorescence-guided surgery 27 patients; Per-margin specificity: Pegulicianine fluorescence-guided surgery 85.2%; Per-margin sensitivity: Pegulicianine fluorescence-guided surgery 49.3%; Second surgeries avoided among patients with positive margins: Pegulicianine fluorescence-guided surgery 9 patients
- Replication: No second randomised pivotal of pegulicianine has reported. Pafolacianine (Cytalux) is a different fluorescent agent for ovarian and lung surgery, and a Lumicell gastrointestinal feasibility study (NCT02584244) is a separate indication.

## Sources

- ClinicalTrials.gov NCT03686215: https://clinicaltrials.gov/study/NCT03686215
- NEJM Evidence 2023: https://doi.org/10.1056/EVIDoa2200333

## 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/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Fluorescence-guided surgery](https://onco.cc/technologies/fluorescence-guided-surgery/), [Optical & fluorescence imaging](https://onco.cc/technologies/optical-imaging/)
- drugs: [Pegulicianine](https://onco.cc/drugs/pegulicianine/)
- companies: [Lumicell](https://onco.cc/companies/lumicell/)
- terms: [Lumpectomy (breast-conserving surgery)](https://onco.cc/terms/lumpectomy/), [Sensitivity and specificity](https://onco.cc/terms/sensitivity-specificity/)
- key papers: [Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery](https://onco.cc/key-papers/paper-smith-nejm-evid/)

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