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NCT Number: NCT06473103

Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rochester Dermatologic Surgery

Victor, New York, 14654, United States

Location status: Recruiting

Location contact

Sherrif Ibrahim, MD-Ph.D.

CONTACT

[email protected]

585-222-1400

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Two photon fluorescence microscopy imaging

Device

Excised tissues will be imaged with two photon fluorescence microscopy prior to submission for histological processing.

Primary outcomes

  1. 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

  1. Overall agreement on margin status

    Time frame: Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery

    The status of margins (positive/negative) will be compared

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Giacomelli, Ph.D.

CONTACT

[email protected]

5852766260

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Rochester Dermatologic Surgery

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2024
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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