Multi-centric Study for Screening and detection of oral potentially malignant disorders (OPMD) non-invasively by fluorescence and diffuse reflectance imaging with OralScan camera, and development of an algorithm for tissue discrimination

The current screening modality practiced in India for detection of oral cancer is visual examination with white light. However, with white light examination, clinicians find it very challenging to locate the most malignant site for biopsy, leading to multiple biopsies or under-diagnosis  and unnecessary biopsies.  Sascan Meditech Pvt Ltd has developed a non-invasive device (OralScan) based on tissue fluorescence and diffuse reflectance imaging  to screen and detect oral precancers in real time. The device consists of multiple LEDs to illuminate the tissue and a monochrome camera to capture multiple images on sequential switching of these LEDs.  The device is connected to a tablet or PC for control using proprietary software. which also takes care of image processing and analysis. The primary purpose of the study is to test the capability of the device to visualize oral potentially malignant diseases (OPMD) of the oral cavity  and identify the most malignant site in the lesion for tissue biopsy, so that under-diagnosis is avoided.  This would be carried out by comparing the accuracy of the current practice with that of the device in this trial. No biopsy will be taken from healthy subjects. The fluorescence images and diffuse reflectance image ratios will be correlated with pathological data and an algorithm would be developed for determining the grade of cancer in real time.  The diagnostic accuracy of the device will also be assessed.  It is hoped that device would evolve as a biopsy guidance tool for clinicians and avoid the large number of false negatives and false positives associated with current practice and help reduce oral cancer burden.