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

Summary

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?

Conditions

• Oral Cancer
• Oral Cavity Cancer
• Oral Leukoplakia
• Oral Lichen Planus
• Oral Squamous Cell Carcinoma

Interventions

DRUG

5-Amino Levulinic Acid

5-ALA (Gleolan) orally (20 mg/kg BW 5-ALA HCl) 2 to 4 hours prior to undergoing image-guided SITOS-based PDT treatment

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• Aligarh Muslim University

  collaborator OTHER

• Karkinos Healthcare Hospitals Ernakulam, Kerala, India

  collaborator UNKNOWN

• National Cancer Institute (NCI)

  collaborator NIH

• University of Massachusetts, Boston

  lead OTHER

Principal Investigators

• Tayyaba Hasan, PhD · Massachusetts General Hospital, Boston, MA, United States

• Jonathan Celli, PhD · University of Massachusetts Boston, Boston, MA, United States

• Moni A Kuriakose, MD · Karkinos Healthcare Hospitals Ernakulam, Kerala, India

• Mohammad Akram, MD · Aligarh Muslim University, Aligarh, Uttar Pradesh, India

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2028-05-31

Completion

2028-12-31

Countries

• India

Study Locations