Cancer
Conditions
Keywords
oral cavity tumor, narrow band imaging, subclinical cancer lesion
Brief summary
This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions.
Interventions
DEVICELocation of the suspected lesions
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
PROCEDUREBiopsy
In case of suspected lesions detected by the NBI technique, this area is biopsied
PROCEDURELesion excision/Surgery
In case of positive biopsy, the suspected lesions is excised
Sponsors
Centre Oscar Lambret
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reliability for detection of subclinical lesions | baseline | Concordance between the histological data and the lesions detected by the NBI technique |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Excision limits quality criteria | baseline | percentage of detection / percentage of false-negative |
| Detection of suspect lesions | baseline | Identify the detection of suspect lesions, aloof from the primitive lesion (percentage of detection / percentage of true-positive) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORSophie EL BEDOUI, MD
Centre Oscar Lambret
Outcome results
None listed