Evaluation of a New Optical Imaging System to Guide Mouth Lesion Biopsies Using the Active Biopsy Guidance System

What this Trial Is About

Researchers are studying the Active Biopsy Guidance System, a new optical imaging device designed to assist doctors in deciding when and where to perform biopsies on mouth lesions. The study aims to evaluate and optimize the technical performance of this device and to provide an initial estimate of its accuracy compared to standard tissue pathology. This research is focused on adults with various oral lesions, including potentially malignant disorders and previous oral cancers. The Active Biopsy Guidance System consists of two main parts an optical mapping scope that shows a wide area of the mouth lining using colored light projections, and a high-resolution microendoscope that captures detailed images of small areas. A fluorescent dye called proflavine hemisulfate is applied to the mouth tissue to enhance image quality. This device is assessed as a diagnostic tool to improve biopsy guidance. Participants will undergo imaging with the device, where pictures of the mouth lining are taken with and without the dye. The study will measure the devices sensitivity and specificity in detecting abnormal tissue compared to biopsy results. The trial involves a single group of participants and continues through to study completion, with ongoing monitoring lasting about one year. The research team monitors participants carefully to understand the devices performance and safety.

Precision Optical Guidance for Oral Biopsy