Investigation of Mohs Surgical Margins Using Two Photon Microscopy

Basal Cell Carcinoma Clinical Trial

Official title:

Investigation of Mohs Surgical Margins Using Two Photon Microscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814900
• Other study ID #: STUDY00008153
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: Michael G Giacomelli, Ph.D
• Phone: 5852766260
• Email: mgiacome[@]ur.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: July 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergoing treatment for BCC with Mohs surgery at the performance site

• Able to read and understand consent form

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma, Basal Cell

Intervention

Device:
• Two photon microscopy imaging
Excised tissues will be imaged with two photon microscopy

Locations

Country	Name	City	State
United States	Rochester Dermatologic Surgery	Victor	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Rochester Dermatologic Surgery

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between frozen sections and two photon microscopy on Mohs margins	The fraction of Mohs surgical margins in which TPFM agrees with FSA will be determined.	During Mohs surgery