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

Primary Purpose

Basal Cell Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
apply methyl-ALA cream
Sponsored by
Assuta Hospital Systems
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Basal Cell Carcinoma focused on measuring bcc

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A- bove 18 years

Exclusion Criteria:

  • Childern
  • Pregnant women

Sites / Locations

  • Assuta hospital

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
March 19, 2007
Last Updated
April 14, 2013
Sponsor
Assuta Hospital Systems
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1. Study Identification

Unique Protocol Identification Number
NCT00449358
Brief Title
Checking Wether the m-ALA Cream Could Mark Correctly the Borders of BCC's Tumors
Official Title
Correlation Between Mohs Surgery and Microscopic Fluorescence Photometry in Determination of Histological Borders in Basal Cell Carcinoma .
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Assuta Hospital Systems

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
Keywords
bcc

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
apply methyl-ALA cream
Primary Outcome Measure Information:
Title
comparing the tumor area measured with the PDD thechnique and the actual tumor size found at the end of the Mohs surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A- bove 18 years Exclusion Criteria: Childern Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enk David, m.d, phd
Organizational Affiliation
Hadassah ein-karem university hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuta hospital
City
Tel-aviv
Country
Israel

12. IPD Sharing Statement

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

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