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van CCT (UK)

van CCT (UK)

Narrow band imaging in head and neck cancer

- candidate number25499
- NTR NumberNTR6199
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-nov-2016
- Secondary IDsMETC 2015/152 NL5315204215
- Public TitleNarrow band imaging in head and neck cancer
- Scientific TitleEstablishing the diagnostic and prognostic role of narrow band imaging in head and neck cancer
- hypothesisDetection, diagnosis, staging, treatment outcome and prognosis of patients with a malignancy of the upper aerodigestive tract improve when Narrow Band Imaging in combination with standard (White Light) endoscopy is used.
- Healt Condition(s) or Problem(s) studiedHead and Neck Squamous Cell Carcinoma
- Inclusion criteria- suspicion of or proven carcinoma of the oral cavity, nasal cavity, pharynx or larynx.
- suspicion of a benign lesion of the larynx
- > 18 yrs of age
- informed consent
- Exclusion criterianone
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 10-sep-2015
- planned closingdate10-sep-2018
- Target number of participants600
- InterventionsObservational cohort study, partially randomized controlled sub-studies.

The intervention itself is not part of the study.
- Primary outcome- Correlation between WLI and / or NBI with histopathological diagnosis.
- Accuracy: percentage of true results = (true positives + true negatives)/ total results.
- Secondary outcomethere are 6 different substudies. Every study has its own secondary outcomes. 4 secondary goals are:
1. To identify NBI + WLI as superior to WLI alone in the early detection of local HNC recurrences after first line treatment
2. To identify NBI + WLI as a better diagnostic and staging tool in the determination of tumor field and as a consequence tumor staging than WLI alone
3. To conclude that inter-observer and intra-observer variability/reliability in the visual analysis of benign and (pre) malignant lesions in the upper aerodigestive tract is higher using NBI+WLI than WLI alone.
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 standard reference in ENT/head and neck oncology in order to increase earlier detection of (pre)malignant HNC lesions using NBI
- Timepoints1. when patients arive in the outpatient clinic with complaints for the first time
2. during surgery
3. follow up: every 3-6 months, depending on diagnosis.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Olympus Medical Systems, University Medical Center Groningen (UMCG)
- Publications
- Brief summaryVisualization by (flexible) endoscopy of the mucosa of oral cavity, nasal cavity, pharynx and larynx is the hallmark in detection and diagnosis of mucosal benign and malignant lesions of the upper aerodigestive tract. Technical improvements resulted in distal chip endoscopes with digital image processing making blood vessels more visible using a technique called Narrow Band Imaging (NBI). NBI is a relatively new imaging technique (developed by Olympus Corporation, Tokyo, Japan) which increases the diagnostic potential of conventional white light imaging (WLI) endoscopy. NBI highlights abnormalities in the superficial vasculature of mucosal lesions by using narrow-bandwidth filters in a sequential red-greenblue illumination system. Although in other fields of medicine NBI has confirmed itself as an important diagnostic and prognostic instrument, in otorhinolaryngology and head and neck oncology, it has not yet been evaluated as an important reliable diagnostic or prognostic tool. We believe NBI should be used as a standard tool in diagnosis and treatment of patients with a (suspected) malignancy of the upper aero-digestive tract, but only after establishing its diagnostic and prognostic value in a large cohort of patients. Therefore, we planned to establish the role of NBI in improving diagnosis, clinical outcome and prognosis in head and neck cancer in six different substudies.
- Main changes (audit trail)
- RECORD3-nov-2016 - 5-mrt-2017

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