Meniere DiseaseNELINCT04569175
Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere's Disease "NELI Study"
A study testing 3D Flair sequence in people with Meniere Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
This study includes 30 patients with Meniere's disease confirmed with AAO-HNS criteria. The aim of this study is to compare the new optimized 3D FLAIR sequence developed at our site with a standard 3D FLAIR sequence performed 4h after a single intravenous dose of macrocyclic gadolinium-based contrast agents for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniere Disease
- What is being tested?
- 3D Flair sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2020to 5 Apr 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman
- older than 18 years old.
- Uni- or bilateral definite or probable clinical diagnosis of MD based on the AAO-HNS guidelines revised in 2015.
- Patient eligible for having contrast-enhanced MRI.
- Patient affiliated of beneficiary of health insurance
- Patient has signed the Informed consent form.
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- Non inclusion criteria:
- History of other pathology of the inner ear.
- History of surgery on the middle or inner ear (tympanoplasty, endolymphatic sac drainage, vestibular schwannoma).
- Pregnant (contraceptive method, HAS criteria) or nursing mothers
- Contraindications to performing MRI (pace maker, metallic shards, claustrophobia)
- Contraindications (relative) to injecting gadolinium (severe renal failure due to the risk of systemic nephrogenic fibrosis, history of allergic reaction)
- Patient under legal protection
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study includes 30 patients with Meniere's disease confirmed with AAO-HNS criteria.
The aim of this study is to compare the new optimized 3D FLAIR sequence developed at our site with a standard 3D FLAIR sequence performed 4h after a single intravenous dose of macrocyclic gadolinium-based contrast agents for the detection of endolymphatic hydrops.
The patients will be explored with the new 3D FLAIR optimized sequence before injection (method to validate) and again 4 hours after contrast media administration with the same sequence 3D FLAIR
Read the detailed description
Meniere's disease (MD) is a pathology of the inner ear defined by episodes of spontaneous vertigo usually accompanied by tinnitus, pressure within the ear and fluctuating sensorineural hearing loss.
Endolymphatic hydrops (EH) is the main pathophysiological substratum of Meniere's disease. Temporal bone MRI has long been used performed to exclude other pathologies mimicking MD, such as vestibular schwannoma or endolymphatic sac tumor.
Currently, delayed 3D-FLAIR sequence is the imaging technique of choice for the diagnosis of endolymphatic hydrops. The endolymphatic space could be assessed on MRI with 3D-FLAIR sequences delayed acquisition after the intravenous administration of gadolinium.
The saccule appears to be the most involved structure in MD. The reproducibility of the hydrops protocols with various MRI scan manufacturers is debatable.
Because endo and peri lymphatic spaces have different biochemical compositions, a new FLAIR 3D sequence on healthy volunteers can be tuned in order to separate endo and peri lymphatic spaces. The hypothesis of the study is that this new method could detect saccular hydrops with the same performances as the standard FLAIR that is done after gadolinium injection.
This study will prospectively include 30 patients with MD confirmed with AAO-HNS criteria . All patients will sign an informed consent. They will be explored with the new 3D FLAIR optimized sequence without injection (method to validate). Then, they will be injected, and they will be explored again 4 hours after contrast product administration with the same sequence (the reference method),to take advantage of the intravenous injection of gadolinium that will be performed in the care. The optimized non enhanced 3D FLAIR sequence will be compared with the reference method and with the same sequence four hours after gadolinium injection.
- Conditions
- Meniere Disease
- Being tested
- 3D Flair sequence
- Keywords
- Meniere's disease, NE 3D FLAIR sequence
- Medical subject headings
- Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Flair sequenceOther
Optimized 3D FLAIR sequence before and 4 hours after the usual care MRI (with contrast product). All patients will have the same intervention as each patient is its own control
| Study group | Role | What they receive |
|---|---|---|
| 3D Flair sequence | Experimental | Optimized 3D FLAIR sequence before and 4 hours after the usual care MRI (with contrast product) Receives: Other: 3D Flair sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kappa coeficient
the non-inferiority of the non-enhanced Flair sequence compared to the reference technique by indirect comparison with the reference method (Kappa coefficient > or equal to 0.81).
Measured: 1 hour before baseline (usual care MRI)
Secondary outcomes (1)
inter-observer correlation
inter-observer correlation coefficient (weighted Kappa).
Measured: 1 hour before baseline, baseline, 4 hours after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start6 Nov 2020
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniere DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569175
- Sponsor's protocol ID
- CHUBX 2020/25
- Other IDs
- 2020-A01699-30
- Acronym
- NELI
- Status last verified
- Jul 2022
- First submitted
- 10 Sep 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere's Disease "NELI Study"
- ClinicalTrials.gov ID
- NCT04569175
- Acronym / sponsor ID
- NELI / CHUBX 2020/25
- Conditions
- Meniere Disease
- Keywords
- Meniere's disease, NE 3D FLAIR sequence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 29 Sep 2020 (actual)
- 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 study includes 30 patients with Meniere's disease confirmed with AAO-HNS criteria.
The aim of this study is to compare the new optimized 3D FLAIR sequence developed at our site with a standard 3D FLAIR sequence performed 4h after a single intravenous dose of macrocyclic gadolinium-based contrast agents for the detection of endolymphatic hydrops.
The patients will be explored with the new 3D FLAIR optimized sequence before injection (method to validate) and again 4 hours after contrast media administration with the same sequence 3D FLAIR
Detailed description
Meniere's disease (MD) is a pathology of the inner ear defined by episodes of spontaneous vertigo usually accompanied by tinnitus, pressure within the ear and fluctuating sensorineural hearing loss.
Endolymphatic hydrops (EH) is the main pathophysiological substratum of Meniere's disease. Temporal bone MRI has long been used performed to exclude other pathologies mimicking MD, such as vestibular schwannoma or endolymphatic sac tumor.
Currently, delayed 3D-FLAIR sequence is the imaging technique of choice for the diagnosis of endolymphatic hydrops. The endolymphatic space could be assessed on MRI with 3D-FLAIR sequences delayed acquisition after the intravenous administration of gadolinium.
The saccule appears to be the most involved structure in MD. The reproducibility of the hydrops protocols with various MRI scan manufacturers is debatable.
Because endo and peri lymphatic spaces have different biochemical compositions, a new FLAIR 3D sequence on healthy volunteers can be tuned in order to separate endo and peri lymphatic spaces. The hypothesis of the study is that this new method could detect saccular hydrops with the same performances as the standard FLAIR that is done after gadolinium injection.
This study will prospectively include 30 patients with MD confirmed with AAO-HNS criteria . All patients will sign an informed consent. They will be explored with the new 3D FLAIR optimized sequence without injection (method to validate). Then, they will be injected, and they will be explored again 4 hours after contrast product administration with the same sequence (the reference method),to take advantage of the intravenous injection of gadolinium that will be performed in the care. The optimized non enhanced 3D FLAIR sequence will be compared with the reference method and with the same sequence four hours after gadolinium injection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D Flair sequence | Experimental | Other: 3D Flair sequenceOptimized 3D FLAIR sequence before and 4 hours after the usual care MRI (with contrast product) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Man or woman
- older than 18 years old.
- Uni- or bilateral definite or probable clinical diagnosis of MD based on the AAO-HNS guidelines revised in 2015.
- Patient eligible for having contrast-enhanced MRI.
- Patient affiliated of beneficiary of health insurance
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 3D Flair sequenceOptimized 3D FLAIR sequence before and 4 hours after the usual care MRI (with contrast product). All patients will have the same intervention as each patient is its own control | Other | 3D Flair sequence |
Primary outcome
Kappa coeficient
Time frame: 1 hour before baseline (usual care MRI)
the non-inferiority of the non-enhanced Flair sequence compared to the reference technique by indirect comparison with the reference method (Kappa coefficient > or equal to 0.81).
1 secondary outcome
inter-observer correlation
Time frame: 1 hour before baseline, baseline, 4 hours after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Flair sequence in people with Meniere Disease, run by University Hospital, Bordeaux 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 13 inclusion and 0 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: finished, as of the sponsor's last update on 1 Jun 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Kappa coeficient (time frame: 1 hour before baseline (usual care MRI)). 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 1 Jun 2026.