Evaluation of Inner Ear and Brain Structures With Contras... | NCT02529475

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

NCT02529475

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

Nov 18, 2020Actual

Enrollment

25Actual

Phase

Phase 4

Conditions

Meniere Disease

Interventions

Gadoteric acid

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment problem-covid-

Expanded Access Info

Start Date

Feb 1, 2016Actual

Primary Completion Date

Sep 2020Actual

Completion Date

Sep 2020Actual

First Submitted Date

Aug 18, 2015

First Submission Date that Met QC Criteria

Aug 19, 2015

First Posted Date

Aug 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2020

Last Update Posted Date

Nov 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gadoteric acid	Experimental	Gadoteric acid 0.2 mmol/kg	Drug: Gadoteric acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gadoteric acid	Drug	Comparison with patients with Meniere's disease	Gadoteric acid

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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 ®

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arnaud ATTYE, PH	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GrenobleUniversityHospital		Grenoble		38043	France
Hôpital Lariboisière

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30413960	Derived	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.

ID	Term
D018159	Endolymphatic Hydrops
D007759	Labyrinth Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases