Excision Limits of Oral Cavity Tumor by Narrow Band Imaging

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01198119
• Other study ID #: NBI-CAB-0907
• Status: Terminated
• Phase: Phase 2
• First received: September 8, 2010
• Last updated: July 31, 2012
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cancer
• Mouth Neoplasms

Intervention

Device:
• Location of the suspected lesions
The suspected lesions will be located before the excision, during the surgery. With traditional light 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
• Lesion excision/Surgery
In case of positive biopsy, the suspected lesions is excised

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability for detection of subclinical lesions	Concordance between the histological data and the lesions detected by the NBI technique	baseline	No
Secondary	Excision limits quality criteria	percentage of detection / percentage of false-negative	baseline	No
Secondary	Detection of suspect lesions	Identify the detection of suspect lesions, aloof from the primitive lesion (percentage of detection / percentage of true-positive)	baseline	No