Synapse - A prospective double-blinded comparison of reflectance confocal microscopy with conventional histopathology for in vivo assessment in oral cancer

A prospective double-blinded comparison of reflectance confocal microscopy with conventional histopathology for in vivo assessment in oral cancer Journal Article

Authors:	Zanoni, D. K.; De Souza França, P. D.; Valero, C.; Peterson, G.; Ardigo, M.; Ghossein, R.; Dusza, S. W.; Matsuura, D.; Scholfield, D. W.; Adilbay, D.; Montero, P. H.; Migliacci, J.; Pillarsetty, N. V. K.; Kose, K.; Ganly, I.; Rajadhyaksha, M.; Patel, S. G.
Article Title:	A prospective double-blinded comparison of reflectance confocal microscopy with conventional histopathology for in vivo assessment in oral cancer
Abstract:	Purpose: We investigated reflectance confocal microscopy (RCM) as a possible noninvasive approach for the diagnosis of cancer and real-time assessment of surgical margins. Experimental Design: In a phase I study on 20 patients, we established the RCM imaging morphologic features that distinguish oral squamous cell carcinoma (OSCC) from normal tissue with a newly developed intraoral RCM probe. Our subsequent phase II prospective double-blinded study in 60 patients tested the diagnostic accuracy of RCM against histopathology. Five RCM videos from the tumor and five from normal surrounding mucosa were collected on each patient, followed by a 3-mm punch biopsy of the imaged area. An experienced RCM reader, who was blinded to biopsy location and histologic diagnosis, examined the videos from both regions and classified each as “tumor” or “not tumor” based on RCM features established in phase I. Hematoxylin and eosin slides from the biopsies were read by a pathologist who was blinded to RCM results. Using histology as the gold standard, we calculated the sensitivity and specificity of RCM. Results: We report a high agreement between the blinded readers (95% for normal tissue and 81.7% for tumors), high specificity (98.3%) and negative predictive values (96.6%) for normal tissue identification, and high sensitivity (90%) and positive predictive values (88.2%) for tumor detection. Conclusions: RCM imaging is a promising technology for noninvasive in vivo diagnosis of OSCC and for real-time intraoperative evaluation of mucosal surgical margins. Its inherent constraint, however, stems from the diminished capability to evaluate structures located at more substantial depths within the tissue. © 2024 The Authors; Published by the American Association for Cancer Research.
Keywords:	adult; clinical article; human tissue; aged; middle aged; major clinical study; clinical trial; case report; neck dissection; squamous cell carcinoma; carcinoma, squamous cell; comparative study; lymph node metastasis; diagnostic accuracy; prospective study; sensitivity and specificity; prospective studies; apoptosis; phase 2 clinical trial; basal cell carcinoma; confocal microscopy; skin biopsy; microscopy, confocal; cohort analysis; pathology; diagnostic imaging; biopsy; fluorescence in situ hybridization; diagnosis; surgery; phase 1 clinical trial; double blind procedure; double-blind method; mouth mucosa; comparative genomic hybridization; mouth neoplasms; mouth cancer; predictive value; surgical margin; mouth squamous cell carcinoma; mouth tumor; tumor invasion; lamina propria; procedures; keratinization; humans; human; male; female; article
Journal Title:	Clinical Cancer Research
Volume:	30
Issue:	11
ISSN:	1078-0432
Publisher:	American Association for Cancer Research
Date Published:	2024-06-01
Start Page:	2486
End Page:	2496
Language:	English
DOI:	10.1158/1078-0432.Ccr-23-1361
PUBMED:	38526414
PROVIDER:	scopus
PMCID:	PMC11145174
DOI/URL:	https://www.scopus.com/inward/record.uri?eid=2-s2.0-85195061782&doi=10.1158%2f1078-0432.CCR-23-1361&partnerID=40&md5=155cf645655eba336e7c11ece5d94393
Notes:	The MSK Cancer Center Support Grant (P30 CA008748) is acknowledge in the PDF -- Corresponding authors is MSK author: Snehal G. Patel -- Source: Scopus