NCT07682831 · University of Rochester
Machine Learning Analysis of Two-photon Fluorescence Microscopy of Dermatologic Biopsies
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Two photon microscopy imaging
Ex vivo tissues will be imaged with two-photon microscopy and analyzed with machine learning for diagnosis
Primary outcome measures
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)
A machine learning model will evaluate TPFM images of patient biopsies at point of care. Sensitivity will be calculated for the machine learning model using two photon fluorescence microscopy images. 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 machine learning model provides a definitive diagnosis. The patient's ultimate clinical diagnosis will serve as the reference standard.
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)
A machine learning model will evaluate TPFM images of patient biopsies at point of care. Specificity will be calculated for the machine learning model using two photon fluorescence microscopy images. 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 machine learning model provides a definitive diagnosis. The patient's ultimate clinical diagnosis will serve as the reference standard.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Victor, New York
Collaborators
National Cancer Institute (NCI), Rochester Dermatologic Surgery
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations