NCT05814900

Investigation of Mohs Surgical Margins Using Two Photon Microscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DEVICE	Two photon microscopy imaging	Excised tissues will be imaged with two photon microscopy

Timeline

• Start date: 2023-06-20
• Primary completion: 2025-06-19
• Completion: 2025-06-19
• First posted: 2023-04-18
• Last updated: 2026-04-02
• Results posted: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study