Two-photon Fluorescence Microscopy of Dermatologic Biopsies

NCT07773688 | Recruiting FDA Device

• 2 other identifiers: STUDY00009823AR37CA258376
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Basal Cell Carcinoma of Skin; Squamous Cell Carcinoma; Melanocytic Lesion, Adult

Keywords

two-photon microscopy

Outcome Measures

Primary Outcomes (2)

• Specificity of TPFM for prediction of the official patient diagnoses

  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.

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

• Sensitivity of TPFM for prediction of the official patient diagnoses

  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.

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

Secondary Outcomes (2)

• Sensitivity of Two Photon Fluorescence Microscopy

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

• Specificity of two photon fluorescence microscopy

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

Study Arms (1)

TPFM imaging of biopsy

EXPERIMENTAL

Specimens will be imaged with TPFM

Device: Two photon microscopy imaging

Interventions

Two photon microscopy imaging DEVICE

Ex vivo tissues will be imaged with two photon microscopy

TPFM imaging of biopsy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Punch, excisional or shave biopsy specimen

You may not qualify if:

• Biopsies composed of multiple excisions or pieces

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator
• Rochester Dermatologic Surgery: collaborator

Study Sites (1)

Rochester Dermatologic Surgery

Victor, New York, 14654, United States

RECRUITING

Related Publications (1)

• Ching-Roa VD, Huang CZ, Ibrahim SF, Smoller BR, Giacomelli MG. Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. JAMA Dermatol. 2022 Oct 1;158(10):1175-1182. doi: 10.1001/jamadermatol.2022.3628.

  PMID: 36069886 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Basal Cell; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Michael G Giacomelli, Ph.D

CONTACT

5852766260; mgiacome@ur.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 19, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)