Investigation of Mohs Surgical Margins Using Two Photon Microscopy
The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during Mohs surgery. The main question it aims to answer is:
• How similar are diagnosis of surgical margins to on two photon fluorescence microscopy compared to frozen section histology
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care frozen section analysis (FSA) for confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation using cryosectioned H&E slides, thus all patients will receive standard of care confirmation following experimental imaging.
Individual excisions from consenting patients will be selected, fluorescently labeled and diagnosed using TPFM. Following imaging, specimens will be cryosectioned as per normal procedure. Following treatment, the results of the TPFM evaluation of each Mohs excisions will be compared to the results from FSA to assess the overall accuracy of TPFM and to determine if TPFM would result in changes to patient care if used without FSA confirmation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Victor, New York, United States, 14654
- Rochester Dermatologic Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergoing treatment for BCC with Mohs surgery at the performance site
- Able to read and understand consent form
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TPFM imaging of surgical margins
Patients will be imaged with TPFM
|
Excised tissues will be imaged with two photon microscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement Between Frozen Sections and Two Photon Fluorescence Microscopy on Mohs Margins
Time Frame: During Mohs surgery, typically less than 60 minutes
|
Sensitivity and specificity of two-photon fluorescence microscopy on Mohs surgical margins compared to frozen sections as gold standard
|
During Mohs surgery, typically less than 60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Specificity of Frozen Sections and Two-photon Fluorescence Microscopy Accounting for Errors Caused Frozen Section Artifacts
Time Frame: During Mohs surgery, typically less than 60 minutes
|
Calculation of specificity using frozen sections as the gold standard but accounting for frozen section artifacts that lead to incorrect treatment outcome.
For example, initially positive on frozen section margins but negative on two-photon fluorescence microscopy because cryosectioning to produce a flat slide has sectioned 100s of microns deeper into the margin and into the tumor is counted as a false positive for frozen section.
|
During Mohs surgery, typically less than 60 minutes
|
|
Sensitivity of Frozen Sections and Two-photon Fluorescence Microscopy on True Margin Diagnosis
Time Frame: During Mohs surgery, typically less than 60 minutes
|
Calculation of sensitivity using frozen sections as the gold standard but accounting for frozen section artifacts that lead to incorrect treatment outcome.
For example, initially negative on frozen section margins but positive on TPFM because a cryosectioning artifact has removed the area of pathology are counted as false negative on frozen sections.
|
During Mohs surgery, typically less than 60 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael G Giacomelli, Ph.D, University of Rochester
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00008153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.