Trial Information
Excision Limits of Oral Cavity Tumor by NARROW BAND IMAGING (NBI): Feasibility Trial
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Reliability for detection of subclinical lesions
Outcome Description:
Concordance between the histological data and the lesions detected by the NBI technique
Outcome Time Frame:
baseline
Safety Issue:
No
Principal Investigator
Sophie EL BEDOUI, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Oscar Lambret
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
NBI-CAB-0907
NCT ID:
NCT01198119
Start Date:
July 2010
Completion Date:
July 2012
Related Keywords:
- Cancer
- oral cavity tumor
- narrow band imaging
- subclinical cancer lesion
- Mouth Neoplasms