scholarly journals Correction to: Feasibility Study of a Novel Protease-Activated Fluorescent Imaging System for Real-Time, Intraoperative Detection of Residual Breast Cancer in Breast Conserving Surgery

2020 ◽  
Vol 27 (S3) ◽  
pp. 967-967
Author(s):  
Barbara L. Smith ◽  
Conor R. Lanahan ◽  
Michelle C. Specht ◽  
Bridget N. Kelly ◽  
Carson Brown ◽  
...  
2020 ◽  
Vol 27 (6) ◽  
pp. 1854-1861 ◽  
Author(s):  
Barbara L. Smith ◽  
Conor R. Lanahan ◽  
Michelle C. Specht ◽  
Bridget N. Kelly ◽  
Carson Brown ◽  
...  

Abstract Background Obtaining tumor-free margins is critical to prevent recurrence after lumpectomy for breast cancer. Unfortunately, current approaches leave positive margins that require second surgeries in 20–40% of patients. We assessed the LUM Imaging System for real-time, intraoperative detection of residual tumor. Methods Breast lumpectomy cavity walls and excised specimens were assessed with the LUM Imaging System after 1 mg/kg intravenous LUM015, a protease-activatable fluorescent agent. Fluorescence at potential sites of residual tumor in lumpectomy cavity walls was evaluated intraoperatively with a sterile hand-held probe, with real-time predictive results displayed on a monitor intraoperatively, and later correlated with histopathology. Results In vivo lumpectomy cavities and excised specimens were imaged after LUM015 injection in 45 women undergoing breast cancer surgery. Invasive ductal and lobular cancers and intraductal cancer (DCIS) were included. A total of 570 cavity margin surfaces in 40 patients were used for algorithm development. Image analysis and display took approximately 1 s per 2.6-cm-diameter circular margin surface. All breast cancer subtypes could be distinguished from adjacent normal tissue. For all imaged cavity surfaces, sensitivity for tumor detection was 84%. Among 8 patients with positive margins after standard surgery, sensitivity for residual tumor detection was 100%; 2 of 8 were spared second surgeries because additional tissue was excised at sites of LUM015 signal. Specificity was 73%, with some benign tissues showing elevated fluorescent signal. Conclusions The LUM015 agent and LUM Imaging System allow rapid identification of residual tumor in the lumpectomy cavity of breast cancer patients and may reduce rates of positive margins.


2021 ◽  
Vol 187 (1) ◽  
pp. 145-153
Author(s):  
Conor R. Lanahan ◽  
Bridget N. Kelly ◽  
Michele A. Gadd ◽  
Michelle C. Specht ◽  
Carson L. Brown ◽  
...  

Abstract 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 < 2 mm from the adjacent specimen margin. LUM015 signal was stable in vivo at least 6.5 h post injection, and ex vivo at least 4 h post excision. Conclusions Intraoperative use of the LUM Imaging System detected all breast cancer subtypes with robust performance independent of menopausal status and breast density. There was no significant impact on histopathology or receptor evaluation.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11591-e11591
Author(s):  
S. Troyan ◽  
S. Gibbs-Strauss ◽  
S. Gioux ◽  
R. Oketokoun ◽  
F. Azar ◽  
...  

e11591 Background: Breast cancer surgery is presently performed without real-time image-guidance. We have developed a novel optical imaging system for image-guided surgery that uses invisible near-infrared (NIR) fluorescent light to highlight structures on the surgical field with high sensitivity, specificity, and contrast. We have also performed the first human clinical trial of the imaging system in women undergoing SLN mapping for breast cancer. Methods: We used a portable imaging system with an articulating arm that has 6 degrees of freedom, high power LED light source, custom optics, custom software, and sterile drape. The imaging system provided simultaneous and real-time imaging of color video and NIR fluorescence at up to 15 frames per second. N = 6 women with biopsy- confirmed breast cancer undergoing SLN mapping gave informed consent. All subjects received conventional mapping with Tc-99m sulfur colloid using a handheld gamma probe as well as NIR fluorescence-guided SLN mapping using a mixture of indocyanine green (ICG) diluted to a final concentration of 10 μM in human serum albumin (ICG:HSA). Results: The imaging system was easy to position in the operating room, with the articulating arm providing 50” horizontal reach and 70” vertical reach. Working distance to the patient was 18”. NIR fluorescence excitation was 20 mW/cm2 at 760 nm. NIR-depleted white light was 40,000 lux. A total of 1.6 ml of ICG:HSA was injected intra-tumorally and peri-tumorally and the site massaged for 5 min. 8 of 9 SLNs identified by Tc- 99m sulfur colloid were also identified by NIR fluorescence. However, NIR fluorescence identified an SLN, confirmed to have cancer in it, that was not identified by Tc-99m sulfur colloid. These differences were consistent with asynchrony in the injection techniques. Unlike the gamma-ray probe, NIR fluorescence provided high-resolution, large area optical imaging of the surgical field, and helped guide surgical resection. Conclusions: In this 6-patient pilot study, a novel NIR fluorescence optical imaging system was used for the first time, and provided real-time image-guided surgery for SLN mapping of breast cancer. No significant financial relationships to disclose.


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