Investigation of Mohs Surgical Margins Using Two Photon Microscopy
1 other identifier
interventional
135
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
June 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2025
CompletedResults Posted
Study results publicly available
March 13, 2026
CompletedApril 2, 2026
March 1, 2026
2 years
March 31, 2023
February 22, 2026
March 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Specificity of Frozen Sections and Two-photon Fluorescence Microscopy Accounting for Errors Caused Frozen Section Artifacts
During Mohs surgery, typically less than 60 minutes
Sensitivity of Frozen Sections and Two-photon Fluorescence Microscopy on True Margin Diagnosis
During Mohs surgery, typically less than 60 minutes
Study Arms (1)
TPFM imaging of surgical margins
EXPERIMENTALPatients will be imaged with TPFM
Interventions
Excised tissues will be imaged with two photon microscopy
Eligibility Criteria
You may qualify if:
- Undergoing treatment for BCC with Mohs surgery at the performance site
- Able to read and understand consent form
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- Rochester Dermatologic Surgerycollaborator
Study Sites (1)
Rochester Dermatologic Surgery
Victor, New York, 14654, United States
Related 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.
PMID: 36069886BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Giacomelli
- Organization
- University of Rochester
Study Officials
- PRINCIPAL INVESTIGATOR
Michael G Giacomelli, Ph.D
University of Rochester
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 31, 2023
First Posted
April 18, 2023
Study Start
June 20, 2023
Primary Completion
June 19, 2025
Study Completion
June 19, 2025
Last Updated
April 2, 2026
Results First Posted
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share