Know Cancer

or
forgot password

Correlation Between Mohs Surgery and Microscopic Fluorescence Photometry in Determination of Histological Borders in Basal Cell Carcinoma .


N/A
18 Years
N/A
Open (Enrolling)
Both
Basal Cell Carcinoma

Thank you

Trial Information

Correlation Between Mohs Surgery and Microscopic Fluorescence Photometry in Determination of Histological Borders in Basal Cell Carcinoma .


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.


Inclusion Criteria:



- A- bove 18 years

Exclusion Criteria:

- Childern

- Pregnant women

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

comparing the tumor area measured with the PDD thechnique and the actual tumor size found at the end of the Mohs surgery

Principal Investigator

Enk David, m.d, phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah ein-karem university hospital

Authority:

Israel: Ministry of Health

Study ID:

1

NCT ID:

NCT00449358

Start Date:

February 2006

Completion Date:

April 2013

Related Keywords:

  • Basal Cell Carcinoma
  • bcc
  • Carcinoma
  • Carcinoma, Basal Cell

Name

Location