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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00449358
Recruitment Status : Unknown
Verified January 2006 by Assuta Hospital Systems.
Recruitment status was:  Active, not recruiting
First Posted : March 20, 2007
Last Update Posted : April 16, 2013
Information provided by:
Assuta Hospital Systems

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

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Procedure: apply methyl-ALA cream Not Applicable

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  (Clinical Trial)
Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Correlation Between Mohs Surgery and Microscopic Fluorescence Photometry in Determination of Histological Borders in Basal Cell Carcinoma .
Study Start Date : February 2006
Estimated Study Completion Date : April 2013

Primary Outcome Measures :
  1. comparing the tumor area measured with the PDD thechnique and the actual tumor size found at the end of the Mohs surgery

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A- bove 18 years

Exclusion Criteria:

  • Childern
  • Pregnant women

Information from the National Library of Medicine

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 identifier (NCT number): NCT00449358

Assuta hospital
Tel-aviv, Israel
Sponsors and Collaborators
Assuta Hospital Systems
Principal Investigator: Enk David, m.d, phd Hadassah ein-karem university hospital Identifier: NCT00449358     History of Changes
Other Study ID Numbers: 1
First Posted: March 20, 2007    Key Record Dates
Last Update Posted: April 16, 2013
Last Verified: January 2006

Keywords provided by Assuta Hospital Systems:

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell