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Investigation of Mohs Surgical Margins Using Two Photon Microscopy

Primary Purpose

Basal Cell Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Two photon microscopy imaging

About this trial

This is an interventional diagnostic trial for Basal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Undergoing treatment for BCC with Mohs surgery at the performance site Able to read and understand consent form Exclusion Criteria: None

Sites / Locations

Rochester Dermatologic SurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TPFM imaging of surgical margins

Arm Description

Patients will be imaged with TPFM

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05814900

First Posted

March 31, 2023

Last Updated

July 11, 2023

Sponsor

University of Rochester

Collaborators

Rochester Dermatologic Surgery

1. Study Identification

Unique Protocol Identification Number

NCT05814900

Brief Title

Investigation of Mohs Surgical Margins Using Two Photon Microscopy

Official Title

Investigation of Mohs Surgical Margins Using Two Photon Microscopy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 20, 2023 (Actual)

Primary Completion Date

June 1, 2025 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

Rochester Dermatologic Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Basal Cell Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TPFM imaging of surgical margins

Arm Type

Experimental

Arm Description

Patients will be imaged with TPFM

Intervention Type

Device

Intervention Name(s)

Two photon microscopy imaging

Intervention Description

Excised tissues will be imaged with two photon microscopy

Primary Outcome Measure Information:

Title

Agreement between frozen sections and two photon microscopy on Mohs margins

Description

The fraction of Mohs surgical margins in which TPFM agrees with FSA will be determined.

Time Frame

During Mohs surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael G Giacomelli, Ph.D

Phone

5852766260

mgiacome@ur.rochester.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael G Giacomelli, Ph.D

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rochester Dermatologic Surgery

City

Victor

State/Province

New York

ZIP/Postal Code

14654

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherrif Ibrahim, MD-Ph.D.

Phone

585-222-1400

dr.ibrahim@rochesterdermsurgery.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36069886

Citation

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.

Results Reference

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Investigation of Mohs Surgical Margins Using Two Photon Microscopy

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