Investigation of Mohs Surgical Margins Using Two Photon Microscopy

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

Study Overview

• Status: Completed
• Conditions: Basal Cell Carcinoma
• Intervention / Treatment: Device: Two photon microscopy imaging

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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Victor, New York, United States, 14654
      • Rochester Dermatologic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPFM imaging of surgical margins; Patients will be imaged with TPFM	Device: Two photon microscopy imaging; Excised tissues will be imaged with two photon microscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement Between Frozen Sections and Two Photon Fluorescence Microscopy on Mohs Margins	Sensitivity and specificity of two-photon fluorescence microscopy on Mohs surgical margins compared to frozen sections as gold standard	During Mohs surgery, typically less than 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of Frozen Sections and Two-photon Fluorescence Microscopy Accounting for Errors Caused Frozen Section Artifacts	Calculation of specificity using frozen sections as the gold standard but accounting for frozen section artifacts that lead to incorrect treatment outcome. For example, initially positive on frozen section margins but negative on two-photon fluorescence microscopy because cryosectioning to produce a flat slide has sectioned 100s of microns deeper into the margin and into the tumor is counted as a false positive for frozen section.	During Mohs surgery, typically less than 60 minutes
Sensitivity of Frozen Sections and Two-photon Fluorescence Microscopy on True Margin Diagnosis	Calculation of sensitivity using frozen sections as the gold standard but accounting for frozen section artifacts that lead to incorrect treatment outcome. For example, initially negative on frozen section margins but positive on TPFM because a cryosectioning artifact has removed the area of pathology are counted as false negative on frozen sections.	During Mohs surgery, typically less than 60 minutes

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Rochester Dermatologic Surgery
• Investigators: Principal Investigator: Michael G Giacomelli, Ph.D, University of Rochester

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Actual): June 19, 2025
• Study Completion (Actual): June 19, 2025

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Basal Cell; Carcinoma, Basal Cell
• Other Study ID Numbers: STUDY00008153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No