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Trial Title:
Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
NCT ID:
NCT06473103
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 fluorescence microscopy imaging
Description:
Excised tissues will be imaged with two photon fluorescence microscopy prior to
submission for histological processing.
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 standard local excision.
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
permanent sections for final margin confirmation. To protect patients, following TPFM
imaging, patients will receive standard of care evaluation on permanent sections, thus
all patients will receive standard of care confirmation following experimental imaging.
Individual excisions from consenting patients will be selected, fluorescently labeled and
the distance to inked margins measured with TPFM. Following imaging, specimens will be
submitted for paraffin processing as per normal procedure and the resulting slides
scanned. The distance to the inked margin will be measured on the permanent sections and
compared to TPFM to determine accuracy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Undergoing treatment for basal cell carcinoma without 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:
October 29, 2024
Completion date:
July 2026
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/NCT06473103
