Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions

The primary goal of this study is to see if photodynamic therapy (PDT) is effective for treatment of lesions in the oral cavity which have high risk of becoming oral cancer. PDT treatment uses a drug, called a photosensitizer, which makes the diseased cells become light-sensitive such that they are destroyed when laser light is delivered to the target lesion. In this study a new handheld device, called SITOS (a "Screen, Image and Treat Optical System), is used. The ability of this device to simultaneously visualize the inside of the mouth and deliver laser light to the target site will be evaluated. The main questions this study seeks to answer are: * Can this treatment completely cure oral potentially malignant lesions (OPML) without need for surgery? * Do lesions recur after PDT treatment? * Is the SITOS device easy to use for the doctor and comfortable for the patient, both as an oral imaging device and as a treatment device?

NCT Number	NCT06876038
Lead Sponsor	University of Massachusetts, Boston Collaborators: Massachusetts General Hospital, University of Arizona, Aligarh Muslim University, Karkinos Healthcare Hospitals Ernakulam, Kerala, India, National Cancer Institute (NCI)
Conditions	Oral Cancer, Oral Cavity Cancer, Oral Leukoplakia, Oral Lichen Planus, Oral Squamous Cell Carcinoma
Enrollment	65 participants
Start Date	2026-09
Primary Completion	2028-05 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-03-19