Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease
NCT ID: NCT02530931
Last Updated: 2020-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
23 participants
INTERVENTIONAL
2016-03-16
2020-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* MR Perfusion Imaging will be assess in both cochlea as well
* Primary auditory brain pathways will be evaluated through MR diffusion imaging
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
patients with Meniere's disease
Gadolinium
diffusion of gadolinium for a population with Meniere's disease in order to develop an imaging disease screening test
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gadolinium
diffusion of gadolinium for a population with Meniere's disease in order to develop an imaging disease screening test
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 on a legal protection regime type guardianship
* Respiratory pathologies, cardiovascular, renal, diabetes
* Claustrophobia
* Contraindications to exposure to a magnetic field
* Contraindications to injecting Dotarem ®
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guerbet
INDUSTRY
University Hospital, Grenoble
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arnaud ATTYE, PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GrenobleUniversityHospital
Grenoble, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
38RC15.173
Identifier Type: -
Identifier Source: org_study_id