Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-03 @ 5:10 PM
Study NCT ID:
NCT06473103
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2024-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: