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Purpose

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?

Conditions

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Punch, excisional or shave biopsy specimen

Exclusion Criteria

  • Biopsies composed of multiple excisions or pieces

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TPFM imaging of biopsy 		Specimens will be imaged with TPFM
  • Device: Two photon microscopy imaging
    Ex vivo tissues will be imaged with two photon microscopy

Recruiting Locations

Rochester Dermatologic Surgery
Victor, New York 14654
Contact:
Sherrif Ibrahim, M.D.-Ph.D.
585-222-1400
dr.ibrahim@rochesterdermsurgery.com

More Details

Status
Recruiting
Sponsor
University of Rochester

Study Contact

Michael G Giacomelli, Ph.D
5852766260
mgiacome@ur.rochester.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.