Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00663910
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Terminated
Phase	Phase 0
Start date	March 2008
Completion date	October 2009

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