Two-photon microscopy on skin biopsies to help diagnose skin lesions
Official title: Expanded Two-photon Imaging of Skin Biopsy Specimens
Run by University of Rochester · NCT07773688 · Data updated 2026-11-12
This study tests whether images from two-photon fluorescence microscopy of dermatology biopsies can match the diagnosis determined by standard histology.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 644 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Victor, New York) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | April 2028 |
| Study ends | April 2028 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT07773688 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults undergoing punch, excisional, or shave biopsies of suspected basal cell carcinoma, squamous cell carcinoma, or melanocytic lesions.
✕Probably not a fit
Patients whose biopsy quality or lesion type does not yield informative images may not benefit from this imaging approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will image freshly obtained skin biopsy samples using two-photon fluorescence microscopy and compare these images to the final histology diagnoses read by a pathologist. The study will also evaluate a machine learning model's ability to predict the same diagnoses from the microscopy images. The goal is to see if rapid, clinic-based imaging can support immediate or faster decision-making about skin lesions. Conventional histology remains the gold standard for comparison. No treatment is altered by this imaging approach.
Why it matters
Potential benefit: If successful, two-photon microscopy could enable quicker preliminary diagnoses and faster clinical decisions for skin lesions.
How similar studies have gone: Other studies have explored advanced imaging to aid skin pathology, with varying concordance to standard histology; this approach is exploratory and builds on prior imaging work.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Punch, excisional or shave biopsy specimen Exclusion Criteria: * Biopsies composed of multiple excisions or pieces
Where it's running
-
Rochester Dermatologic Surgery
Victor, New York, United States Recruiting
Study contacts
- Study coordinator: Michael G Giacomelli, Ph.D
- Email: mgiacome@ur.rochester.edu
- Phone: 5852766260
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.