Meniere's DiseasePhase 4PROSPERNCT02530931
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease
A Phase 4 study testing Gadolinium in people with Meniere's Disease, run by University Hospital, Grenoble at 1 site 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 patient's with Meniere's disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Meniere's Disease
- What is being tested?
- Gadolinium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2016to Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- 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 with clinical criteria of Meniere's disease according to the classification of the American Association of Otology (ie the combination of a sensorineural hearing loss at low frequencies, recurrent vertigo and tinnitus and / or clogged ear sensation)
- 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
1 site in 1 country.
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 patient's with Meniere's disease.
- MR Perfusion Imaging will be assess in both cochlea as well
- Primary auditory brain pathways will be evaluated through MR diffusion imaging
- Conditions
- Meniere's Disease
- Being tested
- Gadolinium
- Medical subject headings
- Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadoliniumDrug
diffusion of gadolinium for a population with Meniere's disease in order to develop an imaging disease screening test
| Study group | Role | What they receive |
|---|---|---|
| patients with Meniere's disease | Experimental | Not described Receives: Drug: Gadolinium |
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 dynamic measurement
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 posted21 Aug 2015 (estimated)
- Study start16 Mar 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.
- Other trials for Meniere's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Sponsor
- Investigators
- Arnaud ATTYE, PH, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530931
- Sponsor's protocol ID
- 38RC15.173
- Acronym
- PROSPER
- Status last verified
- Nov 2020
- First submitted
- 18 Aug 2015
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease
- ClinicalTrials.gov ID
- NCT02530931
- Acronym / sponsor ID
- PROSPER / 38RC15.173
- Conditions
- Meniere's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problem-covid
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in patient's with Meniere's disease.
- MR Perfusion Imaging will be assess in both cochlea as well
- Primary auditory brain pathways will be evaluated through MR diffusion imaging
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Meniere's disease | Experimental | Drug: Gadolinium |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 with clinical criteria of Meniere's disease according to the classification of the American Association of Otology (ie the combination of a sensorineural hearing loss at low frequencies, recurrent vertigo and tinnitus and / or clogged ear sensation)
- Recipient of a French social security scheme
Key exclusion criteria (6 listed)
- Patients minors
- Patients on a legal protection regime type guardianship
- Respiratory pathologies, cardiovascular, renal, diabetes
- Claustrophobia
- Contraindications to exposure to a magnetic field
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadoliniumdiffusion of gadolinium for a population with Meniere's disease in order to develop an imaging disease screening test | Drug | patients with Meniere's disease |
Primary outcome
Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted-Imaging dynamic measurement
Time frame: One MR scan (4 hours)
Results and safety
The study was stopped early (reason given: Recruitment problem-covid). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud ATTYE, PH principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gadolinium in people with Meniere's Disease, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment problem-covid). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted-Imaging dynamic measurement (time frame: One MR scan (4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.