Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer
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|ClinicalTrials.gov Identifier: NCT00663910|
Recruitment Status : Terminated (Of the 8 histologically proven tumors, detection of PpIX proved to be ambiguous.)
First Posted : April 22, 2008
Last Update Posted : January 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-melanomatous Skin Cancer||Drug: Aminolevulinic Acid Procedure: biopsy Procedure: diagnostic imaging technique Procedure: therapeutic conventional surgery||Early Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Protoporphyrin Formation in Non-Melanoma Skin Cancers After Topical Application of 5-Aminolevulinic Acid: A Pilot Study|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
- 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®.Other Name: ALA
- 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.Other Name: Aurora dosimeter
- Procedure: therapeutic conventional surgery
The non-melanoma skin cancer will be excised using the MOHS procedure.
- Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration [ Time Frame: Day 1 ]
- In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods [ Time Frame: Day 1 ]
- Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors [ Time Frame: Day 1 ]
- Establishment of a skin cancer tissue bank [ Time Frame: Day 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663910
|Study Chair:||Edward V. Maytin, MD, PhD||The Cleveland Clinic|