Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy

ConditionBasal Cell Carcinoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergoing treatment for basal cell carcinoma without Mohs surgery at the performance site

Able to read and understand consent form

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

Two photon fluorescence microscopy imaging
Device
Excised tissues will be imaged with two photon fluorescence microscopy prior to submission for histological processing.

Treatment groups

52 Participants

are divided into 1 treatment group

Group A: TPFM imaging of surgical marginsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology

The distance from the furthest extent of the tumor to the nearest surgical margin will be measured on both TPFM and conventional paraffin histology and the numerical difference calculated.

Time frame

Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery

Secondary outcomes

Overall agreement on margin status

The status of margins (positive/negative) will be compared

Time frame

Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Rochester Dermatologic Surgery

Collaborator

Source ClinicalTrials.gov

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