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Trial Title:
Investigation of Mohs Surgical Margins Using Two Photon Microscopy
NCT ID:
NCT05814900
Condition:
Basal Cell Carcinoma
Conditions: Official terms:
Carcinoma, Basal Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Two photon microscopy imaging
Description:
Excised tissues will be imaged with two photon microscopy
Arm group label:
TPFM imaging of surgical margins
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
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Undergoing treatment for BCC with Mohs surgery at the performance site
- Able to read and understand consent form
Exclusion Criteria:
- None
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Rochester Dermatologic Surgery
Address:
City:
Victor
Zip:
14654
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sherrif Ibrahim, MD-Ph.D.
Phone:
585-222-1400
Email:
dr.ibrahim@rochesterdermsurgery.com
Start date:
June 20, 2023
Completion date:
July 1, 2025
Lead sponsor:
Agency:
University of Rochester
Agency class:
Other
Collaborator:
Agency:
Rochester Dermatologic Surgery
Agency class:
Other
Source:
University of Rochester
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05814900
