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

Phase 4TerminatedNCT02529475

University Hospital, Grenoble25 enrolled

Overview

* 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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Meniere Disease

Interventions

Gadoteric acidDRUG

Comparison with patients with Meniere's disease

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 ®

Locations (3)

GrenobleUniversityHospital

Grenoble, France

Hôpital Lariboisière

Paris, France

Hôpital Charles Nicolle

Rouen, France

Outcomes

Primary Outcomes

Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging

Time frame: One MR scan (4 hours)

Data from ClinicalTrials.gov

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