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NCT07773688NARecruiting

Two-photon Fluorescence Microscopy of Dermatologic Biopsies

University of Rochester

Start Date

6/1/2026

Completion Date

4/1/2028

Summary

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?

Detailed Description

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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Punch, excisional or shave biopsy specimen Exclusion Criteria: * Biopsies composed of multiple excisions or pieces

Interventions

DEVICE

Two photon microscopy imaging

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Conditions

Basal Cell Carcinoma of SkinSquamous Cell CarcinomaMelanocytic Lesion, Adult

Locations

Rochester Dermatologic Surgery

Victor, New York 14654

United States