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Completed

NCT Number: NCT05814900

Investigation of Mohs Surgical Margins Using Two Photon Microscopy

The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during Mohs surgery. The main question it aims to answer is:

• How similar are diagnosis of surgical margins to on two photon fluorescence microscopy compared to frozen section histology

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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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rochester Dermatologic Surgery

Victor, New York, 14654, United States

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 frozen section analysis (FSA) for confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation using cryosectioned H&E slides, thus all patients will receive standard of care confirmation following experimental imaging.

Individual excisions from consenting patients will be selected, fluorescently labeled and diagnosed using TPFM. Following imaging, specimens will be cryosectioned as per normal procedure. Following treatment, the results of the TPFM evaluation of each Mohs excisions will be compared to the results from FSA to assess the overall accuracy of TPFM and to determine if TPFM would result in changes to patient care if used without FSA confirmation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergoing treatment for BCC with Mohs surgery at the performance site
  • Able to read and understand consent form

Exclusion criteria

  • None

Treatment and study plan

Two photon microscopy imaging

Device

Excised tissues will be imaged with two photon microscopy

Primary outcomes

  1. Agreement Between Frozen Sections and Two Photon Fluorescence Microscopy on Mohs Margins

    Time frame: During Mohs surgery, typically less than 60 minutes

    Sensitivity and specificity of two-photon fluorescence microscopy on Mohs surgical margins compared to frozen sections as gold standard

Secondary outcomes

  1. Specificity of Frozen Sections and Two-photon Fluorescence Microscopy Accounting for Errors Caused Frozen Section Artifacts

    Time frame: During Mohs surgery, typically less than 60 minutes

    Calculation of specificity using frozen sections as the gold standard but accounting for frozen section artifacts that lead to incorrect treatment outcome. For example, initially positive on frozen section margins but negative on two-photon fluorescence microscopy because cryosectioning to produce a flat slide has sectioned 100s of microns deeper into the margin and into the tumor is counted as a false positive for frozen section.

  2. Sensitivity of Frozen Sections and Two-photon Fluorescence Microscopy on True Margin Diagnosis

    Time frame: During Mohs surgery, typically less than 60 minutes

    Calculation of sensitivity using frozen sections as the gold standard but accounting for frozen section artifacts that lead to incorrect treatment outcome. For example, initially negative on frozen section margins but positive on TPFM because a cryosectioning artifact has removed the area of pathology are counted as false negative on frozen sections.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Rochester Dermatologic Surgery

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2023
Registry last updated
Apr 2, 2026

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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