Excision Limits of Oral Cavity Tumor by Narrow Band Imaging

July 31, 2012 updated by: Centre Oscar Lambret

Excision Limits of Oral Cavity Tumor by NARROW BAND IMAGING (NBI): Feasibility Trial

This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

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

  • France
      • Lille, France, 59020
        • Centre Oscar Lambret

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:

  • Primitive epidermoid cancer of the oral cavity, proved by histology, not treated previously, patient having a surgery
  • No previous surgery for this cancer
  • Age > 18 years
  • Patient affiliated to health insurance
  • Consent signed by the patient

Exclusion Criteria:

  • Metastatic or recurrent disease
  • Health care impossibilities for geographic, social, psychic reasons

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: Patient with oral cavity cancer
Patient treated by surgery for the oral cavity cancer
Device: Location of the suspected lesions

The suspected lesions will be located before the excision, during the surgery.

  1. With traditional light
  2. NBI technique The images will be recorded and compared
Procedure: Biopsy
In case of suspected lesions detected by the NBI technique, this area is biopsied
Procedure: Lesion excision/Surgery
In case of positive biopsy, the suspected lesions is excised

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability for detection of subclinical lesions
Time Frame: baseline
Concordance between the histological data and the lesions detected by the NBI technique
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excision limits quality criteria
Time Frame: baseline
percentage of detection / percentage of false-negative
baseline
Detection of suspect lesions
Time Frame: baseline
Identify the detection of suspect lesions, aloof from the primitive lesion (percentage of detection / percentage of true-positive)
baseline

Collaborators and Investigators

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

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: Sophie EL BEDOUI, MD, Centre Oscar Lambret

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

July 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-CAB-0907

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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