Recruiting

Two-Photon Microscopy

Sponsor:

University of Rochester

Code:

NCT07773688

Conditions

Basal Cell Carcinoma of Skin

Squamous Cell Carcinoma

Melanocytic Lesion, Adult

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Two photon microscopy imaging

Study Details

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

Study ID

NCT07773688

Start date

Jun 1, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Punch, excisional or shave biopsy specimen

Exclusion Criteria:

  • Biopsies composed of multiple excisions or pieces

Study Design

Enrollment

644 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: TPFM imaging of biopsy

Specimens will be imaged with TPFM

Interventions

Two photon microscopy imaging

Ex vivo tissues will be imaged with two photon microscopy

Primary outcome measure

  • Specificity of TPFM for prediction of the official patient diagnoses [ Time Frame: After completion of patient diagnosis (typically 1-2 weeks after procedure) ]
  • Sensitivity of TPFM for prediction of the official patient diagnoses [ Time Frame: After completion of patient diagnosis (typically 1-2 weeks after procedure) ]

Central Contacts and Locations

Central contacts

Michael G Giacomelli, Ph.D

5852766260mgiacome@ur.rochester.edu

Locations

Rochester Dermatologic Surgery

Recruiting

Victor, New York, United States, 14654

Contacts

More Information

Sponsor

University of Rochester

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • two-photon microscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-08-19.