Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
1 other identifier
interventional
52
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 standard local excision.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedStudy Start
First participant enrolled
October 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedMarch 17, 2025
March 1, 2025
1.3 years
June 7, 2024
March 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology
The distance from the furthest extent of the tumor to the nearest surgical margin will be measured on both TPFM and conventional paraffin histology and the numerical difference calculated.
Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery
Secondary Outcomes (1)
Overall agreement on margin status
Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery
Study Arms (1)
TPFM imaging of surgical margins
EXPERIMENTALExcised tissue will be imaged with TPFM to determine the distance from tumor to nearest inked margin.
Interventions
Excised tissues will be imaged with two photon fluorescence microscopy prior to submission for histological processing.
Eligibility Criteria
You may qualify if:
- Undergoing treatment for basal cell carcinoma without 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)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Giacomelli
University of Rochester
Central Study Contacts
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
- Associate Professor
Study Record Dates
First Submitted
June 7, 2024
First Posted
June 25, 2024
Study Start
October 29, 2024
Primary Completion
March 1, 2026
Study Completion
April 1, 2026
Last Updated
March 17, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share