Two-photon Fluorescence Microscopy of Dermatologic Biopsies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Rochester
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Punch, excisional or shave biopsy specimen
Disqualifiers
Biopsies composed of multiple excisions or pieces
Trial design
Design model
Single group
Treatments tested in this trial
Two photon microscopy imaging
DeviceEx vivo tissues will be imaged with two photon microscopy
Treatment groups
644 Participants
are divided into 1 treatment groupGroup A: TPFM imaging of biopsyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Specificity of TPFM for prediction of the official patient diagnoses
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.
Time frame
After completion of patient diagnosis (typically 1-2 weeks after procedure)2
Sensitivity of TPFM for prediction of the official patient diagnoses
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.
Time frame
After completion of patient diagnosis (typically 1-2 weeks after procedure)Secondary outcomes
1
Sensitivity of Two Photon Fluorescence Microscopy
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.
Time frame
After completion of patient diagnosis (typically 1-2 weeks after procedure)2
Specificity of two photon fluorescence microscopy
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.
Time frame
After completion of patient diagnosis (typically 1-2 weeks after procedure)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rochester
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Rochester Dermatologic Surgery
Collaborator
Source ClinicalTrials.gov