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

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ClinicalTrials.gov Identifier: NCT02529475
Recruitment Status : Terminated (recruitment problem-covid-)
First Posted : August 20, 2015
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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

Condition or disease Intervention/treatment Phase
Meniere Disease Drug: Gadoteric acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : September 2020
Actual Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging [ Time Frame: One MR scan (4 hours) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529475


Locations
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France
GrenobleUniversityHospital
Grenoble, France, 38043
Hôpital Lariboisière
Paris, France, 75010
Hôpital Charles Nicolle
Rouen, France, 76038
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Arnaud ATTYE, PH University Hospital, Grenoble
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02529475    
Other Study ID Numbers: 38RC14.428
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases