NCT03610620

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2018

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

July 26, 2018

Last Update Submit

November 25, 2019

Conditions

Basal Cell Carcinoma

Keywords

Basal cell carcinomaMohs surgeryVivascope 2500 ex-vivo fluorescent confocal microscopeFrozen section Mohs histology

Outcome Measures

Primary Outcomes (1)

  • To compare the specificity and sensitivity of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.

    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 Outcomes (1)

  • 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.

    1 DAY

Study Arms (1)

ARM A

EXPERIMENTAL

Vivascope 2500 ex-vivo fluorescent confocal microscope

Procedure: Vivascope 2500 ex-vivo fluorescent confocal microscope

Interventions

Vivascope 2500 ex-vivo fluorescent confocal microscopePROCEDURE

scanned with the Vivascope 2500

ARM A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Eunice Tan, Consultant

    Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Compare accuracy and speed of the Vivascope 2500 to frozen sections.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Services Manager

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 1, 2018

Study Start

June 12, 2017

Primary Completion

August 9, 2018

Study Completion

August 9, 2018

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

GB(1)