Basal Cell Carcinoma of Skin, Melanocytic Lesion, Adult, Squamous Cell Carcinoma
Conditions
Keywords
two-photon microscopy
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?
Detailed description
This study will image biopsy specimens using two-photon fluorescence microscopy (TPFM) and then assess how well the images predict the eventual clinical diagnosis using both an expert pathologist and a machine learning model. Because two-photon images can be acquired from small biopsy specimens within minutes of excision, they could potentially be used to immediately diagnose patients, but the accuracy of TPFM for various skin conditions is unknown. Individual biopsy specimens in a clinic lab will be imaged using TPFM. Following histological processing and patient treatment, resulting histology slides will be scanned for comparison. Images of the histology slides will be read by a pathologist to establish a gold-standard diagnosis and the official diagnosis will be recorded. TPFM images will be evaluated by a pathologist and concordance with the gold-standard determined.
Interventions
Ex vivo tissues will be imaged with two photon microscopy
Sponsors
University of Rochester
National Cancer Institute (NCI)
Rochester Dermatologic Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Punch, excisional or shave biopsy specimen
Exclusion criteria
* Biopsies composed of multiple excisions or pieces
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of TPFM for prediction of the official patient diagnoses | After completion of patient diagnosis (typically 1-2 weeks after procedure) | 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. |
| Sensitivity of TPFM for prediction of the official patient diagnoses | After completion of patient diagnosis (typically 1-2 weeks after procedure) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Two Photon Fluorescence Microscopy | After completion of patient diagnosis (typically 1-2 weeks after procedure) | Sensitivity of two photon fluorescence microscopy images read by a pathologist blinded to the true diagnosis will be determined. 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 there is a definitive diagnosis. A subsequent read of the corresponding conventional histology images after a delay for washout will serve as the ground truth. |
| Specificity of two photon fluorescence microscopy | After completion of patient diagnosis (typically 1-2 weeks after procedure) | Specificity of two photon fluorescence microscopy images read by a pathologist blinded to the true diagnosis will be determined. 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 there is a definitive diagnosis. A subsequent read of the corresponding conventional histology images by the same pathologist after a delay for washout will serve as the ground truth. |
Countries
United States
Contacts
CONTACTMichael G Giacomelli, Ph.D
Outcome results
None listed