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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
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Meniere's Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 18, 2015
Last Updated
November 16, 2020
Sponsor
University Hospital, Grenoble
Collaborators
Guerbet
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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

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

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