Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere's Disease "NELI Study" (NELI)

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

Study Overview

• Status: Completed
• Conditions: Meniere Disease
• Intervention / Treatment: Other: 3D Flair sequence

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D Flair sequence; Optimized 3D FLAIR sequence before and 4 hours after the usual care MRI (with contrast product)	Other: 3D Flair sequence; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 hour before baseline (usual care MRI)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inter-observer correlation	inter-observer correlation coefficient (weighted Kappa).	1 hour before baseline, baseline, 4 hours after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meniere disease categorization	Patient's clinical categorization according to the diagnostic criteria for Meniere's disease formulated by the Classification Committee of the Barany Society in 2015 : definite Meniere's disease and probable Meniere's disease.	1 hour before baseline, baseline, 4 hours after baseline
Degree of endolymphatic hydrops	degree of endolymphatic hydrops: grade I/II/III	1 hour before baseline, baseline, 4 hours after baseline
Volume of endolymphatic hydrops	Volume of endolymphatic hydrops: quantification (mm3)	1 hour before baseline, baseline, 4 hours after baseline
Peak width	peak width in multifrequency tympanometry: average +/- standard deviation	1 hour before baseline, baseline, 4 hours after baseline
Resonant frequency	Resonant frequency: 0 to 2000 Hz	1 hour before baseline, baseline, 4 hours after baseline

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Actual): April 5, 2022
• Study Completion (Actual): April 5, 2022

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Meniere's disease; NE 3D FLAIR sequence
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Endolymphatic Hydrops; Meniere Disease
• Other Study ID Numbers: CHUBX 2020/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No