Treatment of Oral Premalignant Lesions With 5-ALA PDT
Leukoplakia, Erythroplakia
About this trial
This is an interventional treatment trial for Leukoplakia
Eligibility Criteria
Inclusion Criteria:
- At least one grossly visible premalignant lesion (i.e. leukoplakia or erythroplakia) in the oral cavity or oropharynx, with a confirmed diagnosis of leukoplakia with or without dysplasia,measuring ≥ 10 mm in diameter.
- Informed of alternative treatment methods including watchful waiting, laser ablation, or surgical resection.
- Eligible for long-term follow-up for at least one year and be able to tolerate biopsies.
- Subject has signed an informed consent.
- Subject is between the ages of 18 - 80 years of age.
- Male or Female
- Zubrod performance status of 0 or 1 at screening. See Appendix A
Exclusion Criteria:
- Known sensitivity to porphyrins or photoactive medications - See Appendix B
- Invasive carcinoma of the lesion as demonstrated by biopsy.
- Subjects with inherited or acquired blood clotting defects
- Women who are breast feeding, have a positive (+) urine pregnancy test, or refuse to use 2 effective means of contraception during drug exposure and up to 48 hours after.
- Subjects with porphyria
- Life expectancy less than 12 months
- Inability or unwillingness of subject to give written informed consent
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase 1 light dose escalation
Phase 2 - Treatment efficacy of PDT
During Phase I, to determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion. The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD). Procedure: Fluorescence Diagnosis Imaging Interventions: Application of 5-ALA to lesion followed by activation with high power 585 nm pulsed dye laser (PDL-585, ScleroPLUS laser) at 6, 7 and 8 J/cm2.
Procedure: Fluorescence Diagnosis Imaging Interventions: Application of 5-ALA to lesion followed by activation with high power 585 nm pulsed dye laser (PDL-585, ScleroPLUS laser) at 8 J/cm2.