Investigation of Mohs Surgical Margins Using Two Photon Microscopy
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About
The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during Mohs surgery. The main question it aims to answer is:
• How similar are diagnosis of surgical margins to on two photon fluorescence microscopy compared to frozen section histology
Full description
This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care frozen section analysis (FSA) for confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation using cryosectioned H&E slides, thus all patients will receive standard of care confirmation following experimental imaging.
Individual excisions from consenting patients will be selected, fluorescently labeled and diagnosed using TPFM. Following imaging, specimens will be cryosectioned as per normal procedure. Following treatment, the results of the TPFM evaluation of each Mohs excisions will be compared to the results from FSA to assess the overall accuracy of TPFM and to determine if TPFM would result in changes to patient care if used without FSA confirmation.
Enrollment
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Volunteers
Inclusion criteria
- Undergoing treatment for BCC with Mohs surgery at the performance site
- Able to read and understand consent form
Exclusion criteria
- None
Trial design
Primary purpose
Allocation
Interventional model
Masking
135 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Michael G Giacomelli, Ph.D
Data sourced from clinicaltrials.gov
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