CompletedNot Applicable

Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere's Disease "NELI Study"

France14 participantsStarted 2020-11-06

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Kappa coeficient

Timeframe: 1 hour before baseline (usual care MRI)

Trial details

NCT IDNCT04569175

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-05