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Investigation of Mohs Surgical Margins Using Two Photon Microscop

Sponsor
University of Rochester (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05814900
Collaborator
Rochester Dermatologic Surgery (Other)
92
Enrollment
1
Location
1
Arm
25
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Two photon microscopy imaging
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
92 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Investigation of Mohs Surgical Margins Using Two Photon Microscopy
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: TPFM imaging of surgical margins

Patients will be imaged with TPFM

Device: Two photon microscopy imaging
Excised tissues will be imaged with two photon microscopy

Outcome Measures

Primary Outcome Measures

  1. Agreement between frozen sections and two photon microscopy on Mohs margins [During Mohs surgery]

    The fraction of Mohs surgical margins in which TPFM agrees with FSA will be determined.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Undergoing treatment for BCC with Mohs surgery at the performance site

  • Able to read and understand consent form

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rochester Dermatologic Surgery Victor New York United States 14654

Sponsors and Collaborators

  • University of Rochester
  • Rochester Dermatologic Surgery

Investigators

  • Principal Investigator: Michael G Giacomelli, Ph.D, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Michael Giacomelli, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT05814900
Other Study ID Numbers:
  • STUDY00008153
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Carcinoma, Basal Cell

Study Results

No Results Posted as of Apr 18, 2023