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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
406 enrolled.
27 of 357 (about 7.6%); 22 from cavity orientations called negative on standard margin evaluation; met the prespecified threshold
SourceMet the prespecified threshold; the abstract does not give the margin denominator
SourceDid not meet the prespecified threshold
Source9 of 62 patients with positive margins
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Patients in whom fluorescence-guided margins removed residual cancer after standard lumpectomyprimary | Pegulicianine fluorescence-guided surgery | 357 | 27 patients | - | - | link |
| Per-margin specificityprimary | Pegulicianine fluorescence-guided surgery | - | 85.2% | - | - | link |
| Per-margin sensitivityprimary | Pegulicianine fluorescence-guided surgery | - | 49.3% | - | - | link |
| Second surgeries avoided among patients with positive margins | Pegulicianine fluorescence-guided surgery | 62 | 9 patients | - | - | link |
Shares Optical & fluorescence imaging, HER2-positive breast cancer, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer.
Shares Optical & fluorescence imaging, HER2-positive breast cancer, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer.
Shares Optical & fluorescence imaging, Fluorescence-guided surgery, HR-positive / HER2-negative breast cancer.
Shares Optical & fluorescence imaging, Fluorescence-guided surgery.
Shares Optical & fluorescence imaging, Fluorescence-guided surgery, HR-positive / HER2-negative breast cancer.
Shares Optical & fluorescence imaging, Fluorescence-guided surgery.
Shares Lumpectomy (breast-conserving surgery), HER2-positive breast cancer, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer.
Shares Lumpectomy (breast-conserving surgery), HER2-positive breast cancer, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer.