Checking Wether the m-ALA Cream Could Mark Correctly the Borders of BCC's Tumors

April 14, 2013 updated by: Assuta Hospital Systems

Correlation Between Mohs Surgery and Microscopic Fluorescence Photometry in Determination of Histological Borders in Basal Cell Carcinoma .

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-aviv, Israel
        • Assuta hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A- bove 18 years

Exclusion Criteria:

  • Childern
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuta Hospital Systems

Investigators

  • Principal Investigator: Enk David, m.d, phd, Hadassah ein-karem university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

March 19, 2007

First Submitted That Met QC Criteria

March 19, 2007

First Posted (Estimate)

March 20, 2007

Study Record Updates

Last Update Posted (Estimate)

April 16, 2013

Last Update Submitted That Met QC Criteria

April 14, 2013

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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