Excision Limits of Oral Cavity Tumor by Narrow Band Imaging

NCT01198119 | Terminated Phase 2

• 2 other identifiers: NBI-CAB-09012009-A01134-53
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Keywords

oral cavity tumor; narrow band imaging; subclinical cancer lesion

Outcome Measures

Primary Outcomes (1)

• Reliability for detection of subclinical lesions

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

  baseline

Secondary Outcomes (2)

• Excision limits quality criteria

  baseline

• Detection of suspect lesions

  baseline

Study Arms (1)

Patient with oral cavity cancer

EXPERIMENTAL

Patient treated by surgery for the oral cavity cancer

Device: Location of the suspected lesions; Procedure: Biopsy; Procedure: Lesion excision/Surgery

Interventions

Location of the suspected lesions DEVICE

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

Patient with oral cavity cancer

Biopsy PROCEDURE

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

Patient with oral cavity cancer

Lesion excision/Surgery PROCEDURE

In case of positive biopsy, the suspected lesions is excised

Patient with oral cavity cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Neoplasms; Mouth Neoplasms

Interventions

Biopsy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Investigative Techniques

Study Officials

• Sophie EL BEDOUI, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 9, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: December 31, 2014
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

FR (1)