Excision Limits of Oral Cavity Tumor by Narrow Band Imaging

Phase 2TerminatedNCT01198119

Centre Oscar Lambret23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

Location of the suspected lesionsDEVICE

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

BiopsyPROCEDURE

In case of suspected lesions detected by the NBI technique, this area is biopsied

Lesion excision/SurgeryPROCEDURE

In case of positive biopsy, the suspected lesions is excised

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Oscar Lambret

Lille, France

Outcomes

Primary Outcomes

Reliability for detection of subclinical lesions

Concordance between the histological data and the lesions detected by the NBI technique

Time frame: baseline

Secondary Outcomes

Excision limits quality criteria

percentage of detection / percentage of false-negative

Time frame: baseline

Detection of suspect lesions

Identify the detection of suspect lesions, aloof from the primitive lesion (percentage of detection / percentage of true-positive)

Time frame: baseline

Data from ClinicalTrials.gov

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