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MRI scans aim to uncover hidden ear damage in CMV survivors

NCT ID NCT05229744

Knowledge-focused Sponsor: Fondation Ophtalmologique Adolphe de Rothschild 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether people born with cytomegalovirus (CMV) infection who have hearing loss or balance problems also have a condition called endolymphatic hydrops (fluid buildup in the inner ear). Researchers used a special MRI scan with a contrast dye to check for this fluid. The study was small and ended early, but it may help clarify the link between congenital CMV and inner ear issues.

What this could mean

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

Active substance
Gadovist® (gadobutrol, a contrast agent for MRI)
What this could lead to
If successful, this could help doctors understand why some people with congenital CMV develop hearing loss or balance problems, potentially guiding future treatments.
What could go wrong
This was a small, terminated study with only 18 participants, so results may be limited and not apply to everyone. MRI contrast agents carry a small risk of allergic reaction or kidney issues.

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.

Participants

18 people

The number who actually took part.

Started

Dec 2022

Finished

Apr 2025

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Who is studied

Patients with a confirmed history of congenital CMV infection with symptomatic cochleo-vestibular dysfunction (mean hearing threshold\> 20dB in at least one ear and / or functional abnormality in one or more areas at the vestibular level)

Ages

6 months 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: * Patient over 6 months old * With a history of confirmed congenital CMV infection * Suffering from symptomatic cochleo-vestibular dysfunction (average hearing threshold\> 20dB in at least one ear and / or abnormal functioning of one or more sectors at the vestibular level) * For adult patients, having received informed information about the study and having signed a consent to participate in the study * For minor patients written consent of the two holders of the exercise of parental authority * Affiliate or beneficiary of a social security scheme Exclusion Criteria: * Patient benefiting from a legal protection measure * Pregnant or breastfeeding woman * Contraindication to MRI (implanted electrical device, metallic foreign body, claustrophobia) * Patient with a proven allergy to gadolinium * Injection of gadolinium in the previous 7 days * Known impairment of renal function ((estimated GFR \<60 mL / min / 1.73 m²)

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Conditions

The condition(s) this trial relates to.

endolymphatic hydrops fetal cytomegalovirus syndrome

As listed by the trial registrant

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

Endolymphatic hydrops

Contacts and locations

Locations

  • Hôpital Fondation Adolphe de Rothschild

    Paris, PARIS, 75019, France

  • Hôpital Robert Debre

    Paris, 75019, France

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