Investigation of Mohs Surgical Margins Using Two Photon Microscopy

Not Applicable

Recruiting

• Conditions: Basal Cell Carcinoma
• Interventions: Device: Two photon microscopy imaging

• Registration Number: NCT05814900
• Lead Sponsor: University of Rochester

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-18
• Study Start: 2023-06-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Undergoing treatment for BCC with Mohs surgery at the performance site
• Able to read and understand consent form

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TPFM imaging of surgical margins	Two photon microscopy imaging	Patients will be imaged with TPFM

Primary Outcome Measures

Name	Time	Method
Agreement between frozen sections and two photon microscopy on Mohs margins	During Mohs surgery	The fraction of Mohs surgical margins in which TPFM agrees with FSA will be determined.

Trial Locations

Locations (1)

Rochester Dermatologic Surgery; 🇺🇸 Victor, New York, United States