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

November 16, 2020 updated by: University Hospital, Grenoble
  • 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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • GrenobleUniversityHospital
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Rouen, France, 76038
        • Hopital Charles Nicolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 ®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gadoteric acid
Gadoteric acid 0.2 mmol/kg
Drug: Gadoteric acid
Comparison with patients with Meniere's disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging
Time Frame: One MR scan (4 hours)
One MR scan (4 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Arnaud ATTYE, PH, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 20, 2015

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC14.428

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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