Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT00571558
Eligibility Criteria:
Criteria:
* Histologically confirmed oral leukoplakia with dysplasia OR oral leukoplakia with hyperplasia in a high-risk area (e.g., floor of mouth, tongue, or oropharynx)
* Multiple oral leukoplakia lesions are allowed however no more than 5 distinct lesions are biopsied and treated
* All lesions to be treated must be technically accessible by laser
* Patients with oral leukoplakia with hyperplasia in a non-high-risk location (e.g., buccal mucosa from ill-fitting dentures) are not allowed
* Must be willing to undergo baseline biopsies of leukoplakia lesion(s) and surrounding normal tissue 4-8 weeks before therapy and repeat biopsies at 3 months
* No evidence of ongoing radiation damage to the target site
* Karnofsky performance status (PS) 70-100% or Zubrod PS 0-1
* Life expectancy \> 2 years
* Hemoglobin \> 12 g/dL
* Platelet count \> 100,000/mm\^3
* ANC \> 1,500/mm\^3
* Creatinine =\< 1.5 mg/dL
* SGPT and SGOT =\< 1.5 x upper limit of normal (ULN)
* Total bilirubin =\< 1.5 x ULN (a higher level of bilirubin due to a familial metabolism will be considered on an individual basis)
* Willing to adhere to avoidance of sunlight and indoor light exposure for 24 hours after treatment
* Not pregnant or nursing
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to aminolevulinic acid
* No porphyria
* No uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situation that, in the opinion of the investigators, would limit compliance or jeopardize the patient or integrity of the data
* Prior treatment for leukoplakia allowed
* No prior photodynamic therapy
* More than 3 months since prior participation in a clinical trial for leukoplakia
* More than 4 weeks since prior ablative therapy to the target lesion
* More than 4 weeks since prior and no concurrent psoralen or PUVA therapy
* No concurrent oral retinoids (e.g., isotretinoin)
* No concurrent use of tanning beds
* No other concurrent investigational agents
* Fertile patients must use effective contraception
* Patients with a previous diagnosis of stage I or II head and neck cancer are eligible provided definitive therapy, including radiation therapy, is completed and the patient has been rendered disease free for \>= 2 years
* No chronic liver disease including those with normal liver function tests
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00571558
Study Brief:
Protocol Section:
NCT00571558