Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)
- Registration Number
- NCT02529475
- Lead Sponsor
- University Hospital, Grenoble
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
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 ®
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gadoteric acid Gadoteric acid Gadoteric acid 0.2 mmol/kg
- Primary Outcome Measures
Name Time Method Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging One MR scan (4 hours)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
GrenobleUniversityHospital
🇫🇷Grenoble, France
Hôpital Charles Nicolle
🇫🇷Rouen, France
Hôpital Lariboisière
🇫🇷Paris, France