Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere's Disease "N… (NCT04569175) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Kappa coeficient
Timeframe: 1 hour before baseline (usual care MRI)