NCT02306967

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

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

September 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

6.1 years

First QC Date

December 1, 2014

Last Update Submit

May 1, 2018

Conditions

Oral Squamous Cell Carcinoma or Severe Dysplasia

Keywords

oral canceroral dysplasia

Outcome Measures

Primary Outcomes (1)

  • disease specific survival

    disease specific 5 year survival

    5 years

Study Arms (2)

Standard Resection

ACTIVE COMPARATOR

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

FV Guided Resection

EXPERIMENTAL

The oral resection will be guided by fluorescent visualization (FV).

Procedure: resection of oral cancer

Interventions

resection of oral cancerPROCEDURE

Oral cancer will be resected.

FV Guided ResectionStandard Resection

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Hospital

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckMouth Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

September 1, 2011

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations

CA(1)