Clinical trial NCT04949321: Acceleration of the Kinetics of Diffusion of Gadolinium in the Perilymphatic Structures of the Inner Ear.
Official title: Acceleration of the Kinetics of Diffusion of Gadolinium in the Perilymphatic Structures of the Inner Ear.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inner Ear ; Meniere's Disease; Imaging
Keywords: Magnetic Resonance Imaging; Contrast Media
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine the optimal delay after Gadolinium injection to analysis inner ear structures as measured by repeated MR 3D-FLAIR Weighted Imaging. We hypothesize that the endolymphatic structures can be distinguished earlier than 4 hours after contrast media injection.

Detailed description: The gadolinium contrast agents are now required to cross the blood-perilymph inner ear barrier after an intravenous administration in order to assess the endolymphatic structures in patients with vertigo or hearing loss, using MRI with delayed acquisition (at least 4 hours between injection and images acquisition).

This technique relies on the glymphatic diffusion of the gadolinium agents (Naganawa et al.,MRM Sci 2017) and has proved to be useful in patients with Meniere's Disease (Naganawa et al., AJNR 2014, Attyé et al., Eur Radiol 2018), Recurrent Peripheral Vestibulopathy (Attye et al., Eur Radiol 2015) or Otosclerosis (Mukaida et al., Otol Neurotol 2015), leading to numerous scientific publications over the last decade. The inner ear perilymph enhancement is particularly important to distinguish the saccule from the utricle, these inner ear structures were recently used to classify with imaging Meniere's Disease patient (Attye et al; European Radiology 2016).

We recently demonstrated in patients (Eliezer et al., J Neuroradiol 2018), comparing the effect of two macrocyclic contrast agents (Gd-DOTA, Dotarem® and Gd-DO3A-butrol, Gadovist®), that the Gd-DO3A-butrol better enhanced inner ear structures that Gd-DOTA, both with qualitative and quantitative analysis, allowing to more accurately diagnose endolymphatic hydrops in Meniere's Disease patients.

We have speculated that the differences in the physiochemical properties of Gd-contrast agents (concentration, relaxivity, osmalality) are determining factors to cross the blood-perilymph barrier.

These properties should allow scanning diseased patients earlier after contrast media administration, the delay between the injection and MRI acquisition being actually a limitation to expand this technique in the clinical setting, particularly with 1.5T magnets, due to the low Signal to Noise Ratio using 3D-FLAIR sequences analysis.

Here, we want to conduct multi-centre prospective clinical and radiological study to determine the optimal timing to explore Meniere's Disease patient after Gadobutrol injection with single dose intravenous administration.

Eligibility criteria: Inclusion criteria; Healthy volunteers 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 without history of inner ear disease

Meniere's Disease 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)

Exclusion criteria:

Patients minors Patients pregnant Patients on a legal protection regime type guardianship Respiratory pathologies, cardiovascular or renal disorders, neurological diseases Claustrophobia Contraindications to exposure to a magnetic field Contraindications to injecting Gadovist® Other ongoing clinical trials with exclusion period for MRI

Primary outcomes:
measure: Adapted visualization of the saccule and utricle on the early MR sequences when compared to the 4-hours MR 3D FLAIR sequence (gold standard).
timeFrame: 4 hours
Secondary outcomes:
measure: Gadolinium enhancement in basal nuclei as measured by T1 and T2 relaxometry maps.
timeFrame: 4 hours
Other outcomes:
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