Comparison of “click-to-sense” assay with frozen section analysis using simulated surgical margins in breast cancer patients

• Published in: European journal of surgical oncology Vol. 48; no. 7; pp. 1520 - 1526
• Main Authors: Kubo, Anna, Tanei, Tomonori, R Pradipta, Ambara, Morimoto, Koji, Fujii, Motoko, Sota, Yoshiaki, Miyake, Tomohiro, Kagara, Naofumi, Shimoda, Masafumi, Naoi, Yasuto, Motoyama, Yuichi, Morii, Eiichi, Tanaka, Katsunori, Shimazu, Kenzo
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.07.2022
• Subjects: Acrolein; Breast-conserving surgery; Click-to-sense; Surgical margin; Acrolein; Surgical margin; Click-to-sense; Breast-conserving surgery
• ISSN: 0748-7983; 1532-2157
• DOI: 10.1016/j.ejso.2022.04.003

We have shown that “Click-to-sense” (CTS) assay based on the visualization of cancer cells by fluorescence probe targeted for acrolein is useful for differentiating between the malignant and benign lesions of the breast. In the present study, we aimed to apply CTS assay to the examination of the simulated surgical margins, being compared with frozen section (FS) analysis. The simulated surgical margin samples (n = 300) were obtained from 1 to 2 cm distant sites from the tumor margin in the mastectomy specimens of breast cancer patients, and divided into the training (n = 150) and validation (n = 150) set. The samples were subjected to CTS assay, subsequently to FS analysis and finally to permanent section (PS) analysis. Diagnostic accuracy of the CTS assay and FS analysis was evaluated in the examination of the simulated surgical margin status finally determined by the PS analysis. In the training set, sensitivity, specificity, and accuracy was 89.3%, 98.4%, and 96.7% for the CTS assay and 89.3%, 98.4%, and 96.7% for the FS analysis. In the validation set, sensitivity, specificity, and accuracy was 93.3%, 98.3%, and 97.3% for the CTS assay, and 93.3%, 99.2%, and 98.0% for the FS analysis. The CTS assay is as accurate as the FS analysis in the examination of the simulated surgical margins in breast cancer patients, and it seems to have a potential to replace the FS analysis for the intra-operative examination of surgical margins in breast-conserving surgery since it is less labor-intensive and more time-saving than the FS analysis. •Click-to-sense (CTS) assay can visualize cancer cells in live tissue in short time.•It is important to examine surgical margin in breast conserving surgery.•CTS assay was applied to examination of simulated surgical margin samples.•CTS assay was as accurate as frozen section (FS) analysis.