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Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02530931
Acronym
PROSPER
Enrollment
23
Registered
2015-08-21
Start date
2016-03-16
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's 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 patient's with Meniere's disease. * MR Perfusion Imaging will be assess in both cochlea as well * Primary auditory brain pathways will be evaluated through MR diffusion imaging

Interventions

DRUGGadolinium

diffusion of gadolinium for a population with Meniere's disease in order to develop an imaging disease screening test

Sponsors

Guerbet
CollaboratorINDUSTRY
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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 with clinical criteria of Meniere's disease according to the classification of the American Association of Otology (ie the combination of a sensorineural hearing loss at low frequencies, recurrent vertigo and tinnitus and / or clogged ear sensation) * 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

MeasureTime frame
Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted-Imaging dynamic measurementOne MR scan (4 hours)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026