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Excision Limits of Oral Cavity Tumor by Narrow Band Imaging

This study has been terminated.
(lack of recruitment)
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01198119
First received: September 8, 2010
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Cancer
 Device: Location of the suspected lesions
Procedure: Biopsy
Procedure: Lesion excision/Surgery
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Excision Limits of Oral Cavity Tumor by NARROW BAND IMAGING (NBI): Feasibility Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Oral Cancer
U.S. FDA Resources

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Reliability for detection of subclinical lesions [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Concordance between the histological data and the lesions detected by the NBI technique


Secondary Outcome Measures:
  • Excision limits quality criteria [ Time Frame: baseline ] [ Designated as safety issue: No ]
    percentage of detection / percentage of false-negative

  • Detection of suspect lesions [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Identify the detection of suspect lesions, aloof from the primitive lesion (percentage of detection / percentage of true-positive)


Enrollment: 23
Study Start Date: July 2010
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198119

Locations
France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Sophie EL BEDOUI, MD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01198119     History of Changes
Other Study ID Numbers: NBI-CAB-0907
Study First Received: September 8, 2010
Last Updated: July 31, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
oral cavity tumor
narrow band imaging
subclinical cancer lesion

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Neoplasms
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on June 18, 2013