Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02529475

Acronym

HYDROPS

Enrollment

Registered

2015-08-20

Start date

2016-02-01

Completion date

2020-09-30

Last updated

2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniere Disease

Brief summary

* This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in healthy subjects * MR Perfusion Imaging will be assess in both cochlea as well * Primary auditory brain pathways will be evaluated through MR diffusion imaging

Interventions

DRUGGadoteric acid

Comparison with patients with Meniere's disease

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Major subjects of over 40 years (mean age of Meniere's disease 40 to 50 years) * Informed consent signed * Medical examination performed prior to participation in research * Patients without history of inner ear disease * Recipient of a French social security scheme

Exclusion criteria

* Patients minors * Patients on a legal protection regime type guardianship * Respiratory pathologies, cardiovascular, renal, diabetes * Claustrophobia * Contraindications to exposure to a magnetic field * Contraindications to injecting Dotarem ®

Design outcomes

Primary

Measure	Time frame
Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging	One MR scan (4 hours)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026