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

NCT04569175 | Completed

• 1 other identifier: CHUBX 2020/25
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Meniere Disease

Keywords

Meniere's disease; NE 3D FLAIR sequence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• inter-observer correlation

  1 hour before baseline, baseline, 4 hours after baseline

Other Outcomes (5)

• Meniere disease categorization

  1 hour before baseline, baseline, 4 hours after baseline

• Degree of endolymphatic hydrops

  1 hour before baseline, baseline, 4 hours after baseline

• Volume of endolymphatic hydrops

  1 hour before baseline, baseline, 4 hours after baseline

Study Arms (1)

3D Flair sequence

EXPERIMENTAL

Optimized 3D FLAIR sequence before and 4 hours after the usual care MRI (with contrast product)

Other: 3D Flair sequence

Interventions

3D Flair sequence OTHER

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

3D Flair sequence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Meniere Disease

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 29, 2020
• Study Start: November 6, 2020
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)