Meniere DiseasePhase 4HYDROPSNCT02529475
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)
A Phase 4 study testing Gadoteric acid in people with Meniere Disease, run by University Hospital, Grenoble at 3 sites in France.
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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meniere Disease
- What is being tested?
- Gadoteric acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Feb 2016to Sep 2020
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 ®
Trial locations and contacts
3 sites in 1 country.
France3 sites
GrenobleUniversityHospital
Grenoble, 38043
Hôpital Lariboisière
Paris, 75010
Hôpital Charles Nicolle
Rouen, 76038
About this study
- 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
- Conditions
- Meniere Disease
- Being tested
- Gadoteric acid
- Medical subject headings
- Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadoteric acidDrug
Comparison with patients with Meniere's disease
| Study group | Role | What they receive |
|---|---|---|
| Gadoteric acid | Experimental | Gadoteric acid 0.2 mmol/kg Receives: Drug: Gadoteric acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging
Measured: One MR scan (4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study start1 Feb 2016
- Primary completionSep 2020
- Study completionSep 2020
Why it stopped: recruitment problem-covid-
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meniere DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud ATTYE, PH, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529475
- Sponsor's protocol ID
- 38RC14.428
- Acronym
- HYDROPS
- Status last verified
- Nov 2020
- First submitted
- 18 Aug 2015
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30413960