Confocal Microscopy Evaluation of Margin Clearance in Basal Cell Carcinomas in Mohs Surgery (FCM-P)

November 25, 2019 updated by: Julie Dawson

Does Ex-vivo Fluorescence Confocal Microscopy Allow Faster Evaluation of Margin Clearance in Basal Cell Carcinomas in Mohs Surgery: A Pilot Study

This study is comparing the accuracy and speed of the Vivascope 2500 ex-vivo fluorescent confocal microscope with frozen section Mohs histology in evaluating clear margins in basal cell carcinoma in Mohs surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with basal cell carcinomas in the head and neck area, being considered for Mohs surgery with frozen sections will be invited to participate in this trial by the investigators when they attend for their pre-surgical consultation. They will be given sufficient time to review the information sheet and ask questions. When they attend for their Mohs surgery, they will be recruited if they wish to participate in this trial, at which point, the investigator, or an authorized member of their team, will obtain written informed consent for patients. The patient will then undergo Mohs surgery. The processing and interpretation with frozen sections will be conducted in the same way, the only difference being immediately after the BCC is excised with a Mohs bevelled edge (45o incision), the tissue is immersed in acridine orange (nuclear DNA stain) and placed upside down with the deep margin of the tissue face up. With a glass slide placed on top, we would place the FCM (Vivascope 2500) over this, scan the tissue and obtain mosaic images of the tissue which would be stitched together. The penetration of the FCM scan is approximately 0.25mm. This is approximately the distance between 2-3 Mohs wafers. The investigators would usually consider a margin of 3 Mohs wafers (300 microns) clear. When the scanning is completed (5 minutes), the Mohs layer would be sent for frozen section (stained with haematoxylin and eosin) for confirmation in the usual way. The Mohs surgeon can interpret the FCM mosaic images later. Acridine orange does not interfere with frozen sections or paraffin histopathological quality. No medicines will be used in this study. The information is collected on only 1 patient visit. There is no follow up period. The main objectives would (1) compare the accuracy in detection of BCC margins with FCM compared with FSM and (2) evaluate the time taken for processing and interpretation of FCM (acridine orange inking and rinsing, image acquisition and mosaic stitching, and image interpretation) compared with the time taken for processing and interpretation of FSM (sample flattening, freezing and cutting with the cryostat, H&E staining, slide cover slipping and slide interpretation).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk & Norwich University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 years or older
  2. Patient with basal cell carcinoma on the head and neck undergoing Mohs surgery with frozen sections
  3. Patient willing and able to give informed consent
  4. Patient treated not previously or currently treated with a hedgehog inhibitor medication (vismodegib)
  5. Patient suitable for Mohs surgery
  6. Excised lesion suitable for scanning with FCM as determined by investigator -

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM A
Vivascope 2500 ex-vivo fluorescent confocal microscope
Procedure: Vivascope 2500 ex-vivo fluorescent confocal microscope
scanned with the Vivascope 2500

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the specificity and sensitivity of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
Time Frame: 1 DAY
Compare the specificity and sensitivity of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
1 DAY

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the time taken for processing and interpretation of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
Time Frame: 1 DAY
Compare the time taken for processing and interpretation of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
1 DAY

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julie Dawson

Collaborators

Mavig GmbH

Investigators

  • Principal Investigator: Eunice Tan, Consultant, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2017

Primary Completion (Actual)

August 9, 2018

Study Completion (Actual)

August 9, 2018

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212591

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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