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New MRI scan could diagnose Meniere's disease without needle dye

NCT ID NCT04569175

Diagnosis Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new MRI technique to detect endolymphatic hydrops (fluid buildup) in the inner ear of people with Meniere's disease. The new method uses a special 3D FLAIR sequence without contrast dye, compared to the standard method that requires an injection. The goal was to see if the non-contrast scan is just as good at spotting the fluid buildup. The study involved 14 adults with confirmed Meniere's disease, and each person acted as their own control by having both types of scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
3D FLAIR MRI sequence (imaging technique)
What this could lead to
If successful, this could lead to a safer, contrast-free MRI method for diagnosing Meniere's disease, reducing patient exposure to gadolinium-based contrast agents.
What could go wrong
This is a small, early-stage study with only 14 participants, so results may not apply to all patients. The new MRI method may not be as accurate as the standard contrast-enhanced approach.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Started

Nov 2020

Finished

Apr 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Meniere disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Meniere disease

Contacts and locations

Locations

  • CHU Bordeaux

    Bordeaux, France

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