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NCT Number: NCT07773688

Two-photon Fluorescence Microscopy of Dermatologic Biopsies

The goal of this study is to investigate the ability of two-photon fluorescence microscopy to evaluate dermatologic biopsies. The main questions it aims to answer are:

• How well do two-photon fluorescence images of biopsies taken in a clinic and evaluated by a pathologist agree with conventional histology?

Recruiting

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Key information

Conditions

Basal Cell Carcinoma of Skin Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Melanocytic Lesion, Adult Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma

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, M.D.-Ph.D.

CONTACT

[email protected]

585-222-1400

About this study

This study will image biopsy specimens using two-photon fluorescence microscopy (TPFM) and then assess how well the images predict the eventual clinical diagnosis using both an expert pathologist and a machine learning model. Because two-photon images can be acquired from small biopsy specimens within minutes of excision, they could potentially be used to immediately diagnose patients, but the accuracy of TPFM for various skin conditions is unknown.

Individual biopsy specimens in a clinic lab will be imaged using TPFM. Following histological processing and patient treatment, resulting histology slides will be scanned for comparison. Images of the histology slides will be read by a pathologist to establish a gold-standard diagnosis and the official diagnosis will be recorded. TPFM images will be evaluated by a pathologist and concordance with the gold-standard determined.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Punch, excisional or shave biopsy specimen

Exclusion criteria

  • Biopsies composed of multiple excisions or pieces

Treatment and study plan

Two photon microscopy imaging

Device

Ex vivo tissues will be imaged with two photon microscopy

Primary outcomes

  1. Specificity of TPFM for prediction of the official patient diagnoses

    Time frame: After completion of patient diagnosis (typically 1-2 weeks after procedure)

    Specificity is defined as the number of true negative diagnoses divided by the sum of true negative and false positive diagnoses among biopsy specimens for which the pathologist returned a definitive diagnosis. The patient's ultimate clinical diagnosis will serve as the reference standard.

  2. Sensitivity of TPFM for prediction of the official patient diagnoses

    Time frame: After completion of patient diagnosis (typically 1-2 weeks after procedure)

    Sensitivity is defined as the number of true positive diagnoses divided by the sum of true positive and false negative diagnoses among biopsy specimens for which the pathologist returns a definitive diagnosis.

Secondary outcomes

  1. Sensitivity of Two Photon Fluorescence Microscopy

    Time frame: After completion of patient diagnosis (typically 1-2 weeks after procedure)

    Sensitivity of two photon fluorescence microscopy images read by a pathologist blinded to the true diagnosis will be determined. Sensitivity is defined as the number of true positive diagnoses divided by the sum of true positive and false negative diagnoses among biopsy specimens for which there is a definitive diagnosis. A subsequent read of the corresponding conventional histology images after a delay for washout will serve as the ground truth.

  2. Specificity of two photon fluorescence microscopy

    Time frame: After completion of patient diagnosis (typically 1-2 weeks after procedure)

    Specificity of two photon fluorescence microscopy images read by a pathologist blinded to the true diagnosis will be determined. Specificity is defined as the number of true negative diagnoses divided by the sum of true negative and false positive diagnoses among biopsy specimens for which there is a definitive diagnosis. A subsequent read of the corresponding conventional histology images by the same pathologist after a delay for washout will serve as the ground truth.

Study contacts

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

Michael G Giacomelli, Ph.D

CONTACT

[email protected]

5852766260

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Cancer Institute (NCI)
  • Rochester Dermatologic Surgery

Registry information

Official study title

Expanded Two-photon Imaging of Skin Biopsy Specimens

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Aug 19, 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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