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

Starting soon · Phase 2

Conditions studied: Oral Cancer, Oral Cavity Cancer, Oral Leukoplakia, Oral Lichen Planus, Oral Squamous Cell Carcinoma

In brief

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?

Key facts

Study ID

NCT06876038

Run by

University of Massachusetts, Boston

People needed

65

Starts

2026-09-01

Expected to finish

2028-12-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Hypersensitivity against active substances and porphyrins.
• Known diagnosis of porphyria.
• Simultaneous use of other potentially phototoxic substances (eg; tetracyclines, sulphonamides, fluoroquinolones, hypericin extracts).
• Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled cardiac and renal diseases or psychiatric illness.
• Subjects with inherited or acquired bleeding and clotting disorders
• Women who are breastfeeding/ have a positive urine pregnancy test or are planning their family.
• Patients who have taken supplements of retinol, beta carotene, vitamin E, Selenium, or other chemo-preventive therapy at least one month prior to the baseline visit.
• Patients with histological evidence of no dysplasia, mild dysplasia, invasive carcinoma, and any active malignant disease.
• Patients with behavioral and cognitive impairment.
• Patients who are concurrently diagnosed and undergoing treatment for other head and neck cancers.
• Patients with large lesions, which, in the investigator's opinion, may require reconstructive surgery after excision.
• The subjects, in the opinion of the Institutional Principal Investigator, are not an appropriate candidate for study participation due to alcoholism and abstinence.
• Patient who was in a clinical trial for 4 weeks before participation in the present trial.

Where it is running

• Karkinos Healthcare Hospitals — Ernākulam, Kerala, India
• Jawaharlal Nehru Medical College, AMU — Aligarh, Uttar Pradesh, India

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.