Status:
NOT_YET_RECRUITING
Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions
Lead Sponsor:
University of Massachusetts, Boston
Collaborating Sponsors:
Massachusetts General Hospital
University of Arizona
Conditions:
Oral Cancer
Oral Cavity Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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,...
Detailed Description
This study seeks to evaluate the efficacy of photodynamic therapy (PDT) using aminolevulinic acid (ALA) photosensitization for treatment of oral potentially malignant lesions (OPML) or early stage ora...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06876038
Start Date
May 1 2025
End Date
May 1 2028
Last Update
March 14 2025
Active Locations (2)
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1
Karkinos Healthcare Hospitals
Ernākulam, Kerala, India
2
Jawaharlal Nehru Medical College, AMU
Aligarh, Uttar Pradesh, India, 202002