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Spots Global Cancer Trial Database for Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

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Trial Identification

Brief Title: Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

Official Title: Evaluation of Protoporphyrin Formation in Non-Melanoma Skin Cancers After Topical Application of 5-Aminolevulinic Acid: A Pilot Study

Study ID: NCT00663910

Study Description

Brief Summary: RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma skin cancer that has been treated with topical aminolevulinic acid may help doctors predict how patients will respond to photodynamic therapy. PURPOSE: This clinical trial is studying topical aminolevulinic acid in patients with nonmelanoma skin cancer.

Detailed Description: OBJECTIVES: * To evaluate the distribution and depth of protoporphyrin IX (PpIX) within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration. * To obtain in vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods. * To correlate the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors. * To establish a skin cancer tissue bank. OUTLINE: Topical aminolevulinic acid (ALA) is applied to the center of the tumor surface. Patients then undergo punch tumor biopsy of the area where the ALA is applied followed by surgery to remove the tumor. Tissue samples are assessed for protoporphyrin (PpIX) levels by fluorescence confocal microscopy and hyperspectral imaging. Excess tumor tissue may be stored in a skin cancer tissue bank. Surface measurements (from a total of 5 surface sites) of PpIX fluorescence are taken at baseline and at 2 hours after ALA application using an optical fiber-based hand-held dosimeter.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Edward V. Maytin, MD, PhD

Affiliation: The Cleveland Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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