Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Rochester
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Undergoing treatment for basal cell carcinoma without Mohs surgery at the performance site
- •Able to read and understand consent form
Exclusion Criteria
- Not provided
Arms & Interventions
TPFM imaging of surgical margins
Excised tissue will be imaged with TPFM to determine the distance from tumor to nearest inked margin.
Intervention: Two photon fluorescence microscopy imaging (Device)
Outcomes
Primary Outcomes
Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology
Time Frame: 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 Outcomes
- Overall agreement on margin status(Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery)
Investigators
Michael Giacomelli
Associate Professor
University of Rochester