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

Meniere's Disease Clinical Trial

— PROSPER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02530931
• Other study ID #: 38RC15.173
• Status: Terminated
• Phase: Phase 4
• Start date: March 16, 2016
• Est. completion date: September 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 ®

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

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

Locations

Country	Name	City	State
France	GrenobleUniversityHospital	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Guerbet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted-Imaging dynamic measurement		One MR scan (4 hours)