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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02529475
Other study ID # 38RC14.428
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date February 1, 2016
Est. completion date September 2020

Study information

Verified date November 2020
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Terminated
Enrollment 25
Est. completion date September 2020
Est. primary completion date September 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Gadoteric acid
Comparison with patients with Meniere's disease

Locations

Country Name City State
France GrenobleUniversityHospital Grenoble
France Hôpital Lariboisière Paris
France Hôpital Charles Nicolle Rouen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging One MR scan (4 hours)
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