Fluorescent Visualization in Early Oral Cancer

May 1, 2018 updated by: Joseph C. Dort, University of Calgary
Studies from Vancouver show that fluorescent visualization (FV) is a useful method of controlling surgical margins. This early finding will now be confirmed in a national randomized controlled trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Foothills Hospital

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:

  • biopsy proven invasive oral cancer or severe dysplasia / Cis
  • invasive cancer must be T1 or T2
  • no prior history of oral cancer / treatment of oral cancer

Exclusion Criteria:

  • prior history of oral cancer
  • unable to provide informed consent
  • lesion not able to be completely visualized by FV

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Resection
Oral resection will be guided by usual practice. This involves identifying the tumour with white light and then marking surgical margins and resection the primary cancer.
Procedure: resection of oral cancer
Oral cancer will be resected.
Procedure: resection of oral cancer
Oral cancer will be resected
Experimental: FV Guided Resection
The oral resection will be guided by fluorescent visualization (FV).
Procedure: resection of oral cancer
Oral cancer will be resected.
Procedure: resection of oral cancer
Oral cancer will be resected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease specific survival
Time Frame: 5 years
disease specific 5 year survival
5 years

Collaborators and Investigators

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

Sponsor

University of Calgary

Collaborators

Terry Fox Research Institute

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)

September 1, 2011

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCENT004

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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