arrow band imaging in head and neck cancer
Recruiting
- Conditions
- - All adult patients with a suspected malignant mucosal lesion of the upper aerodigestive tract - Patients with benign upper aerodigestive tract lesions
- Registration Number
- NL-OMON27129
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
suspicion of or proven carcinoma of the oral cavity, nasal cavity, pharynx or larynx.
- suspicion of a benign lesion of the larynx
Exclusion Criteria
none
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Correlation between WLI and / or<br>NBI with histopathological diagnosis. <br /><br>- Accuracy: percentage of true results = (true positives + true negatives)/ total results.
- Secondary Outcome Measures
Name Time Method there are 6 different substudies. Every study has its own secondary outcomes. 4 secondary goals are: <br /><br>1. To identify NBI + WLI as superior to WLI alone in the early detection of local HNC<br>recurrences after first line treatment<br /><br>2. To identify NBI + WLI as a better diagnostic and staging tool in the determination of<br>tumor field and as a consequence tumor staging than WLI alone<br /><br>3. To conclude that inter-observer and intra-observer variability/reliability in the visual<br>analysis of benign and (pre) malignant lesions in the upper aerodigestive tract is<br>higher using NBI+WLI than WLI alone.<br /><br>4. To increase reliability and decrease inter-/intra-observer variability by creating a NBIatlas which will be helpful in correct interpretation of NBI and can be used as a<br>standard reference in ENT/head and neck oncology in order to increase earlier<br>detection of (pre)malignant HNC lesions using NBI