Investigation of Mohs Surgical Margins Using Two Photon Microscopy

NCT ID: NCT05814900

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2025-06-19

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.

Conditions

Basal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

TPFM imaging of surgical margins

Patients will be imaged with TPFM

Group Type: EXPERIMENTAL

Two photon microscopy imaging

Intervention Type: DEVICE

Excised tissues will be imaged with two photon microscopy

Interventions

Two photon microscopy imaging

Excised tissues will be imaged with two photon microscopy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rochester Dermatologic Surgery

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Michael Giacomelli

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael G Giacomelli, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Rochester Dermatologic Surgery

Victor, New York, United States

Countries

United States

References

Ching-Roa VD, Huang CZ, Ibrahim SF, Smoller BR, Giacomelli MG. Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. JAMA Dermatol. 2022 Oct 1;158(10):1175-1182. doi: 10.1001/jamadermatol.2022.3628.

Reference Type: BACKGROUND

PMID: 36069886 (View on PubMed)

Other Identifiers

STUDY00008153

Identifier Type: -

Identifier Source: org_study_id