Meniere Disease Clinical Trial
— NELIOfficial title:
Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere's Disease "NELI Study"
Verified date | July 2022 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study includes 30 patients with Meniere's disease confirmed with AAO-HNS criteria. The aim of this study is to compare the new optimized 3D FLAIR sequence developed at our site with a standard 3D FLAIR sequence performed 4h after a single intravenous dose of macrocyclic gadolinium-based contrast agents for the detection of endolymphatic hydrops. The patients will be explored with the new 3D FLAIR optimized sequence before injection (method to validate) and again 4 hours after contrast media administration with the same sequence 3D FLAIR
Status | Completed |
Enrollment | 14 |
Est. completion date | April 5, 2022 |
Est. primary completion date | April 5, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Man or woman - older than 18 years old. - Uni- or bilateral definite or probable clinical diagnosis of MD based on the AAO-HNS guidelines revised in 2015. - Patient eligible for having contrast-enhanced MRI. - Patient affiliated of beneficiary of health insurance - Patient has signed the Informed consent form. Non inclusion criteria: - History of other pathology of the inner ear. - History of surgery on the middle or inner ear (tympanoplasty, endolymphatic sac drainage, vestibular schwannoma). - Pregnant (contraceptive method, HAS criteria) or nursing mothers - Contraindications to performing MRI (pace maker, metallic shards, claustrophobia) - Contraindications (relative) to injecting gadolinium (severe renal failure due to the risk of systemic nephrogenic fibrosis, history of allergic reaction) - Patient under legal protection |
Country | Name | City | State |
---|---|---|---|
France | CHU Bordeaux | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Meniere disease categorization | Patient's clinical categorization according to the diagnostic criteria for Meniere's disease formulated by the Classification Committee of the Barany Society in 2015 : definite Meniere's disease and probable Meniere's disease. | 1 hour before baseline, baseline, 4 hours after baseline | |
Other | Degree of endolymphatic hydrops | degree of endolymphatic hydrops: grade I/II/III | 1 hour before baseline, baseline, 4 hours after baseline | |
Other | Volume of endolymphatic hydrops | Volume of endolymphatic hydrops: quantification (mm3) | 1 hour before baseline, baseline, 4 hours after baseline | |
Other | Peak width | peak width in multifrequency tympanometry: average +/- standard deviation | 1 hour before baseline, baseline, 4 hours after baseline | |
Other | Resonant frequency | Resonant frequency: 0 to 2000 Hz | 1 hour before baseline, baseline, 4 hours after baseline | |
Primary | Kappa coeficient | the non-inferiority of the non-enhanced Flair sequence compared to the reference technique by indirect comparison with the reference method (Kappa coefficient > or equal to 0.81). | 1 hour before baseline (usual care MRI) | |
Secondary | inter-observer correlation | inter-observer correlation coefficient (weighted Kappa). | 1 hour before baseline, baseline, 4 hours after baseline |
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