Performance of a novel protease-activated fluorescent imaging system for intraoperative detection of residual breast cancer during breast conserving surgery

Purpose Safe breast cancer lumpectomies require microscopically clear margins. Real-time margin assessment options are limited, and 20–40% of lumpectomies have positive margins requiring re-excision. The LUM Imaging System previously showed excellent sensitivity and specificity for tumor detection d...

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Bibliographic Details
Published in:Breast cancer research and treatment 2021-05, Vol.187 (1), p.145-153
Main Authors: Lanahan, Conor R., Kelly, Bridget N., Gadd, Michele A., Specht, Michelle C., Brown, Carson L., Hughes, Kevin S., Tang, Rong, Rai, Upahvan, Brachtel, Elena F., Rice-Stitt, Travis, Smith, Barbara L.
Format: Article
Language:English
Subjects:
Breast cancer
Cancer
Cancer research
Cancer surgery
Clinical Trial
Histochemistry
Histopathology
Lumpectomy
Medicine
Medicine & Public Health
Menopause
Methylene blue
Oncology
Oncology, Experimental
Post-menopause
Postmenopausal women
Proteases
Proteinase
Surgery
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Summary:Purpose Safe breast cancer lumpectomies require microscopically clear margins. Real-time margin assessment options are limited, and 20–40% of lumpectomies have positive margins requiring re-excision. The LUM Imaging System previously showed excellent sensitivity and specificity for tumor detection during lumpectomy surgery. We explored its impact on surgical workflow and performance across patient and tumor types. Methods We performed IRB-approved, prospective, non-randomized studies in breast cancer lumpectomy procedures. The LUM Imaging System uses LUM015, a protease-activated fluorescent imaging agent that identifies residual tumor in the surgical cavity walls. Fluorescent cavity images were collected in real-time and analyzed using system software. Results Cavity and specimen images were obtained in 55 patients injected with LUM015 at 0.5 or 1.0 mg/kg and in 5 patients who did not receive LUM015. All tumor types were distinguished from normal tissue, with mean tumor:normal ( T : N ) signal ratios of 3.81–5.69. T : N ratios were 4.45 in non-dense and 4.00 in dense breasts ( p  = 0.59) and 3.52 in premenopausal and 4.59 in postmenopausal women ( p  = 0.19). Histopathology and tumor receptor testing were not affected by LUM015. Falsely positive readings were more likely when tumor was present
ISSN:0167-6806
1573-7217
DOI:10.1007/s10549-021-06106-w