Overview

This trial is active, not recruiting.

Condition basal cell carcinoma
Treatment apply methyl-ala cream
Sponsor Assuta Hospital Systems
Start date February 2006
End date April 2013
Trial size 32 participants
Trial identifier NCT00449358, 1

Summary

Correlation between Mohs surgery and microscopic fluorescence photometry in determination of histological borders in Basal Cell Carcinoma .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Measure
comparing the tumor area measured with the PDD thechnique and the actual tumor size found at the end of the Mohs surgery
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - A- bove 18 years Exclusion Criteria: - Childern - Pregnant women

Additional Information

Official title Correlation Between Mohs Surgery and Microscopic Fluorescence Photometry in Determination of Histological Borders in Basal Cell Carcinoma .
Principal investigator Enk David, m.d, phd
Description Background: Basal Cell Carcinoma (BCC) is the most common form of nonmelanoma skin cancer worldwide. BCCs are slow-growing, locally invasive tumors that rarely metastasize but can cause extensive morbidity through local tissue destruction. Recurrence is often the consequence of incomplete removal of the cancer tissue. Mohs' micrographic surgery is considered the most effective treatment modality for BCC with a recurrence rate of less than 5 %, however, the technique requires specialized training and is labor-intensive and costly. Fluorescence imaging by topical application of a tumor-localizing agent such as methyl 5-aminolevulinic acid (MAL), resulting in buildup of photosensitizing porphyrin IX (PpIX) that can be visualized by Woods' light fluorescence, might serve as a quick and simple "bed-side" technique for demarcation of BCC tumor borders prior to surgical excision Objective: To test the reliability of MAL-induced porphyrin fluorescence tumor demarcation by comparison with the tumor borders determined by Mohs' surgery Methods: Twenty eight patients with facial BCCs (17 nodular, 3 superficial, 1 morphea type, 3 ulcerated and 4 recurrent tumors) scheduled for Mohs' surgery were recruited for the study. The night before the surgical procedure, crusts were gently removed and an approximately 1 mm thick layer of a cream containing 16 % MAL (MetvixR) was applied to the tumor area as well as to the surrounding skin and covered by a transparent occlusive dressing. The following morning (10-17 hours after MetvixR application), the dressing was removed, and the lesion size was determined with a caliber by measuring the largest perpendicular diameters under natural (clinical size) and Woods' (fluorescence size) illumination. The patients then underwent the scheduled Mohs' surgical procedure, and the tumor size (Mohs' size) was determined when reaching the tumor free margins.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Assuta Hospital Systems.