Recruiting

Machine Learning Model

Sponsor:

University of Rochester

Code:

NCT07682831

Conditions

Basal Cell Carcinoma of Skin

Squamous Cell Carcinoma (Skin)

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 a machine learning model to evaluate two-photon fluorescence microscopy images of dermatologic biopsies at point of care.

The main question it aims to answer is:

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

Conditions

Basal Cell Carcinoma of Skin

Squamous Cell Carcinoma (Skin)

Study ID

NCT07682831

Start date

Jun 24, 2026

Status verified date

Aug, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Punch, excisional or shave biopsy specimen

Exclusion Criteria:

  • Biopsy indication includes melanoma or dysplastic/atypical nevus
  • Excision thickness of less than 1 mm
  • Excision longest dimension less than 2 mm
  • Excision performed as multiple pieces in a single specimen container

Study Design

Enrollment

92 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 and diagnosed using a machine learning model

Interventions

Two photon microscopy imaging

Ex vivo tissues will be imaged with two-photon microscopy and analyzed with machine learning for diagnosis

Primary outcome measure

  • Sensitivity of Machine Learning Analysis of Two Photon Fluorescence Microscopy Images At Point of Care [ Time Frame: During or immediately following patient biopsy (same day) ]
  • Specificity of Machine Learning Analysis of Two Photon Fluorescence Microscopy Images At Point of Care [ Time Frame: During or immediately following patient biopsy (same day) ]

Central Contacts and Locations

Central contacts

Michael Giacomelli, Ph.D

5852766260mgiacome@ur.rochester.edu

Locations

Rochester Dermatologic Surgery

Recruiting

Victor, New York, United States, 14654

Contacts

Sherrif Ibrahim, M.D.-Ph.D.

585-222-1400dr.ibrahim@rochesterdermsurgery.com

More Information

Sponsor

University of Rochester

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • two-photon microscopy
  • machine learning

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.