Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral… (NCT06876038) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions
India65 participantsStarted 2026-09
Plain-language 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?
Who can participate
Age range18 Years – 65 Years
SexALL
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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
Exclusion criteria
✕. 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.