Validation of a Point-of-Care Optical Coherence Tomography Device with Machine Learning Algorithm for Detection of Oral Potentially Malignant and Malignant Lesions

Abstract

Simple Summary

Early detection is crucial towards improving survival in patients diagnosed with oral cancer. Non-invasive strategies equivalent to histology diagnosis are extremely valuable in oral cancer screening and early detection in resource-constrained settings. Optical coherence tomography (OCT), an optical biopsy technique enables real-time imaging with periodic surveillance and capability to image architectural features of the tissues. We report that while OCT system delineates oral pre-cancer and cancer with more than 90% sensitivity, integration, with artificial neural network-based analysis efficiently identifies high-risk, oral pre-cancer (83%). This study provides evidence that the robust, low-cost system was effective as a point-of-care device in resource-constrained settings. The high accuracy and portability signify widespread clinical application in oral cancer screening and/or surveillance.

Abstract

Non-invasive strategies that can identify oral malignant and dysplastic oral potentially-malignant lesions (OPML) are necessary in cancer screening and long-term surveillance. Optical coherence tomography (OCT) can be a rapid, real time and non-invasive imaging method for frequent patient surveillance. Here, we report the validation of a portable, robust OCT device in 232 patients (lesions: 347) in different clinical settings. The device deployed with algorithm-based automated diagnosis, showed efficacy in delineation of oral benign and normal ( n = 151), OPML ( n = 121), and malignant lesions ( n = 75) in community and tertiary care settings. This study showed that OCT images analyzed by automated image processing algorithm could distinguish the dysplastic-OPML and malignant lesions with a sensitivity of 95% and 93%, respectively. Furthermore, we explored the ability of multiple ( n = 14) artificial neural network (ANN) based feature extraction techniques for delineation high grade-OPML (moderate/severe dysplasia). The support vector machine (SVM) model built over ANN, delineated high-grade dysplasia with sensitivity of 83%, which in turn, can be employed to triage patients for tertiary care. The study provides evidence towards the utility of the robust and low-cost OCT instrument as a point-of-care device in resource-constrained settings and the potential clinical application of device in screening and surveillance of oral cancer.