Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy

Not Applicable

Recruiting

• Conditions: Basal Cell Carcinoma
• Interventions: Device: Two photon fluorescence microscopy imaging

• Registration Number: NCT06473103
• Lead Sponsor: University of Rochester

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.

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 permanent sections for final margin confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation on permanent sections, thus all patients will receive standard of care confirmation following experimental imaging. Individual excisions from consenting patients will be selected, fluorescently labeled and the distance to inked margins measured with TPFM. Following imaging, specimens will be submitted for paraffin processing as per normal procedure and the resulting slides scanned. The distance to the inked margin will be measured on the permanent sections and compared to TPFM to determine accuracy.

Study Timeline

• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-18
• Study First Posted: 2024-06-25
• Study Start: 2024-10-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Undergoing treatment for basal cell carcinoma without Mohs surgery at the performance site
• Able to read and understand consent form

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TPFM imaging of surgical margins	Two photon fluorescence microscopy imaging	Excised tissue will be imaged with TPFM to determine the distance from tumor to nearest inked margin.

Primary Outcome Measures

Name	Time	Method
Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology	Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery	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.

Secondary Outcome Measures

Name	Time	Method
Overall agreement on margin status	Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery	The status of margins (positive/negative) will be compared

Trial Locations

Locations (1)

Rochester Dermatologic Surgery; 🇺🇸 Victor, New York, United States