NCT06473103

Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DEVICE	Two photon fluorescence microscopy imaging	Excised tissues will be imaged with two photon fluorescence microscopy prior to submission for histological processing.

Timeline

• Start date: 2024-10-29
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2024-06-25
• Last updated: 2025-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study