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


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer

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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

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