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Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS) (HYDROPS)

Primary Purpose

Meniere Disease

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Gadoteric acid
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Meniere Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts 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 without history of inner ear disease
  • 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
  • Hôpital Lariboisière
  • Hôpital Charles Nicolle

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gadoteric acid

Arm Description

Gadoteric acid 0.2 mmol/kg

Outcomes

Primary Outcome Measures

Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging

Secondary Outcome Measures

Full Information

First Posted
August 18, 2015
Last Updated
November 16, 2020
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02529475
Brief Title
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)
Acronym
HYDROPS
Official Title
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
recruitment problem-covid-
Study Start Date
February 1, 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

4. Oversight

Data Monitoring Committee
Yes

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 healthy subjects 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 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
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gadoteric acid
Arm Type
Experimental
Arm Description
Gadoteric acid 0.2 mmol/kg
Intervention Type
Drug
Intervention Name(s)
Gadoteric acid
Intervention Description
Comparison with patients with Meniere's disease
Primary Outcome Measure Information:
Title
Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging
Time Frame
One MR scan (4 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 without history of inner ear disease 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
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76038
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30413960
Citation
Eliezer M, Maquet C, Horion J, Gillibert A, Toupet M, Bolognini B, Magne N, Kahn L, Hautefort C, Attye A. Detection of intralabyrinthine abnormalities using post-contrast delayed 3D-FLAIR MRI sequences in patients with acute vestibular syndrome. Eur Radiol. 2019 Jun;29(6):2760-2769. doi: 10.1007/s00330-018-5825-0. Epub 2018 Nov 9.
Results Reference
derived

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Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)

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