Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease (PROSPER)
Primary Purpose
Meniere's Disease
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Gadolinium
Sponsored by
About this trial
This is an interventional diagnostic trial for Meniere's Disease
Eligibility Criteria
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 ®
Sites / Locations
- GrenobleUniversityHospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients with Meniere's disease
Arm Description
Outcomes
Primary Outcome Measures
Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted-Imaging dynamic measurement
Secondary Outcome Measures
Full Information
NCT ID
NCT02530931
First Posted
August 18, 2015
Last Updated
November 16, 2020
Sponsor
University Hospital, Grenoble
Collaborators
Guerbet
1. Study Identification
Unique Protocol Identification Number
NCT02530931
Brief Title
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease
Acronym
PROSPER
Official Title
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruitment problem-covid
Study Start Date
March 16, 2016 (Actual)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Guerbet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with Meniere's disease
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gadolinium
Intervention Description
diffusion of gadolinium for a population with Meniere's disease in order to develop an imaging disease screening test
Primary Outcome Measure Information:
Title
Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted-Imaging dynamic measurement
Time Frame
One MR scan (4 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 ®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud ATTYE, PH
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
GrenobleUniversityHospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease
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