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Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy

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University of Rochester

Status

Enrolling

Conditions

Basal Cell Carcinoma

Treatments

Device: Two photon fluorescence microscopy imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT06473103
STUDY00009521

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

52 participants in 1 patient group

TPFM imaging of surgical margins
Experimental group
Description:
Excised tissue will be imaged with TPFM to determine the distance from tumor to nearest inked margin.
Treatment:
Device: Two photon fluorescence microscopy imaging

Trial contacts and locations

1

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Central trial contact

Michael Giacomelli, Ph.D.

Data sourced from clinicaltrials.gov

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