Checking Wether the m-ALA Cream Could Mark Correctly the Borders of BCC's Tumors
Recruitment status was Active, not recruiting
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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 . |
- 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 |
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 |
Inclusion Criteria:
- A- bove 18 years
Exclusion Criteria:
- Childern
- Pregnant women
Contacts and Locations
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 May 23, 2013