NCT06876038Not yet recruitingPhase 2

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

A Comprehensive Platform for Low-cost Screening and Image-guided Photodynamic Therapy (PDT) Treatment of Pre-malignant and Malignant Oral Lesions in Low-resource Setting

Source: ClinicalTrials.gov · Last updated 19 Mar 2026

Brief summary (registry, in English)

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?

Status (registry): Not yet recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 65 (estimated)
First submitted: 9 Mar 2025
Start date: Sept 2026
Primary completion date: May 2028
Lead sponsor: University of Massachusetts, Boston
Diseases: Head and neck cancer
NCT number: NCT06876038

What you commit to

Study type: Interventional · Phase 2
Planned participants: 65
From Sept 2026 to the primary completion date, May 2028
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.
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 large lesions, which, in the investigator's opinion, may require reconstructive surgery after excision.
Patient who was in a clinical trial for 4 weeks before participation in the present trial.

Other illness

Hypersensitivity against active substances and porphyrins.
Subjects with inherited or acquired bleeding and clotting disorders
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.

Other

Known diagnosis of porphyria.
Simultaneous use of other potentially phototoxic substances (eg; tetracyclines, sulphonamides, fluoroquinolones, hypericin extracts).
Women who are breastfeeding/ have a positive urine pregnancy test or are planning their family.
The subjects, in the opinion of the Institutional Principal Investigator, are not an appropriate candidate for study participation due to alcoholism and abstinence.

Criteria the registry did not label

Subject Inclusion Criteria
One grossly visible OPML, with histopathologically confirmed diagnosis of moderate, severe, and carcinoma in situ measuring ≥ 10 mm in diameter.
Willing and available for follow-up for at least one year and at prerequisite time intervals.
All patients above the age of 18 years and willing to voluntarily give a signed informed consent.
Karnofsky Performance Score above 80 or ECOG 0 or 1.
The subjects meeting the following laboratory eligibility criteria during a time not older than 2 months before accrual
- Hemoglobin level above or equal to 10%
- WBC \>3000/mm3
- Platelets count \>100000/mm3
- Total bilirubin, AST (SGOT), ALT (SGPT) \< 1.5 times the Upper Limit Normal
- eGFR \> 60 ml/min
- Serum Creatine less than 2 times the Upper Limit of laboratory normal
- INR/ PT and PTT within laboratory normal limits

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Jawaharlal Nehru Medical College, AMU Coordinator of this site? Confirm its status	Aligarh	India	Unknown status
Karkinos Healthcare Hospitals Coordinator of this site? Confirm its status	Ernākulam	India	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.