Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449358
Status:
UNKNOWN
Last Update Posted:
2013-04-16
First Post:
2007-03-19
Brief Title:
Checking Wether the m-ALA Cream Could Mark Correctly the Borders of BCCs Tumors
Sponsor:
Assuta Hospital Systems
Organization:
Assuta Hospital Systems
Study Overview
Official Title:
Correlation Between Mohs Surgery and Microscopic Fluorescence Photometry in Determination of Histological Borders in Basal Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None