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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Assuta Hospital Systems.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT00449358
First received: March 19, 2007
Last updated: April 14, 2013
Last verified: January 2006
  Purpose

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


Condition Intervention
Basal Cell Carcinoma
Procedure: apply methyl-ALA cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Correlation Between Mohs Surgery and Microscopic Fluorescence Photometry in Determination of Histological Borders in Basal Cell Carcinoma .

Resource links provided by NLM:


Further study details as provided by Assuta Hospital Systems:

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

Estimated Enrollment: 32
Study Start Date: February 2006
Estimated Study Completion Date: April 2013
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A- bove 18 years

Exclusion Criteria:

  • Childern
  • Pregnant women
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00449358

Locations
Israel
Assuta hospital
Tel-aviv, Israel
Sponsors and Collaborators
Assuta Hospital Systems
Investigators
Principal Investigator: Enk David, m.d, phd Hadassah ein-karem university hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00449358     History of Changes
Other Study ID Numbers: 1
Study First Received: March 19, 2007
Last Updated: April 14, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Assuta Hospital Systems:
bcc

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

ClinicalTrials.gov processed this record on August 01, 2014