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Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

NCT00663910 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-01-02

No results posted yet for this study

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.

Conditions

  • Non-melanomatous Skin Cancer

Interventions

DRUG

Aminolevulinic Acid

On Day 1, ALA will then be applied topically to the center of the tumor surface (at the location of its greatest diameter) in a standardized manner with great care not to include normal skin. The solution will be applied directly to the lesions by dabbing gently with a wet applicator tip. Enough solution will be applied to uniformly wet the exposed lesion surface. Once the initial application has dried, the ALA will be applied again in the same manner. The ALA will be left on for 2 hours under occlusion with Duoderm Extra Thin®.

PROCEDURE

biopsy

Then local anesthesia, lidocaine 1% with epinephrine 1:100,000, will be administered and before the tumor is excised by one of the Cleveland Clinic MOHS surgeons, a 2mm punch biopsy will be taken from the area where the ALA was previously applied. The punch biopsy will be full thickness, extending to the subcutaneous fat.

PROCEDURE

diagnostic imaging technique

Two hours after the amniolevlulenic acid was applied, the measurements of surface fluorescence will be repeated with the hand held dosimeter.

PROCEDURE

therapeutic conventional surgery

The non-melanoma skin cancer will be excised using the MOHS procedure.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Edward V. Maytin, MD, PhD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-10-31
Completion
2009-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00663910 on ClinicalTrials.gov