Study the diffusion kinetics of gadolinium at the perilymph of the inner ear structures to patients Meniere's disease - PROSPER

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002375-22-FR

Enrollment

Registered

2015-06-26

Start date

2015-07-27

Completion date

Unknown

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Meniere's disease MedDRA version: 18.0 Level: PT Classification code 10027183 Term: Meniere's disease System Organ Class: 10013993 - Ear and labyrinth disorders

Interventions

Trade Name: DOTAREM Product Name: DOTAREM Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All subjects with the following criteria may be included in this study: • Major subjects of over 50 years (mean age of Meniere's disease 40 to 50 years (Sajjadi and Paparella, 2008), 55 years in our sample) • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • 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 ®

Design outcomes

Primary

Measure	Time frame
Main Objective: Development of a diagnostic test MRI of Meniere's disease, including a prodromal stage, for studying the vascular permeability of the inner ear.;Secondary Objective: • Study of the central auditory pathways in search of brain damage associated with cochleovestibular reached. • Study of the sensitivity and specificity of early and late MRI in detecting confrontation in Meniere's disease with electrophysiological ENT examinations: electrocochleography, otoacoustic emissions and evoked potentials otolithic;Primary end point(s): Quantitative study by the method of the interest areas of enhancement kinetics in the first 4 hours after injection of a single intravenous dose of gadoteric acid in the cochlea of patients with Meniere's disease. These repeat sequences in hyperpondération T2 minutes at regular intervals to quantify the shortening of the relaxation time and the echo delay for product to pass across the blood Gadoline-labyrinthine barrier	—

Measure

Time frame

Main Objective: Development of a diagnostic test MRI of Meniere's disease, including a prodromal stage, for studying the vascular permeability of the inner ear.;Secondary Objective: • Study of the central auditory pathways in search of brain damage associated with cochleovestibular reached. • Study of the sensitivity and specificity of early and late MRI in detecting confrontation in Meniere's disease with electrophysiological ENT examinations: electrocochleography, otoacoustic emissions and evoked potentials otolithic;Primary end point(s): Quantitative study by the method of the interest areas of enhancement kinetics in the first 4 hours after injection of a single intravenous dose of gadoteric acid in the cochlea of patients with Meniere's disease. These repeat sequences in hyperpondération T2 minutes at regular intervals to quantify the shortening of the relaxation time and the echo delay for product to pass across the blood Gadoline-labyrinthine barrier

—

Countries

France

Contacts

Public ContactDr Arnaud ATTYE

University Hospital grenoble

AAttye@chu-grenoble.fr3304 76 76 34 50

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026