Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-07
Brief Title:
Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
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?:
None