Visualization of Endolymphatic HydRops: Techniques of ImaGing Optimization

Ménière*s disease (MD) is an inner ear disorder characterized by recurrent
self-limiting attacks of vertigo associated with fluctuating sensorineural
hearing loss, tinnitus, and aural fullness. Although the pathophysiology of MD
remains unclear, it is universally agreed that the pathogenesis includes
development of endolymphatic hydrops (EH). The diagnosis of MD currently relies
solely on clinical criteria. Unfortunately, distinguishing MD from other
vertigo-associated inner ear disorders is complicated by lack of a specific
diagnostic test and a high degree of clinical heterogeneity, especially in
early stages of the disease. Recently, 3T MR imaging after delayed IV
Gadolinium showed promising results in visualizing EH in vivo using 3D IR and
3D FLAIR techniques. However, the value and exact clinical application in MD
has not yet been validated. Moreover, all studies on the visualization of EH so
far have involved clinically well-defined patients with MD. The diagnostic
value of EH in patients with vertigo of unclear origin is uncertain. Treatment
for MD differs from other inner ear disorders, thereby emphasizing the
importance of accurate and early diagnosis. To date, no studies are available
which specifically address imaging derived parameters in therapeutic evaluation
strategies. The visualization of EH, using delayed IV Gd-enhanced 3D FLAIR MRI,
may aid clinicians in diagnosing MD and monitor treatment effects.

To develop a robust MR imaging protocol applicable in the diagnostic workup and
follow up of suspected MD patients.

The present study is a prospective cohort study that will be carried out in the
Haga Teaching Hospital in The Hague.

Most patients included in this study will undergo standard of care MR imaging,
except for post-treatment imaging of the patients undergoing IT dexamethasone
and EDB. Investigational MRI requires a new IV contrast bolus. Gadolinium-based
contrast media have a very low risk of allergic-like reactions. MRI up to 8T is
considered a non-significant risk by the FDA and ICNIRP. No significant risks
are expected.

There are no direct benefits for the patients participating in this study,
although evaluation of endolymphatic hydrops may help to start relevant
treatment in an early phase of the disease. Nevertheless, their participation
will contribute to a better understanding of the value of MRI in patients with
MD. Moreover, an imaging-based substrate for Meniere disease in vivo does help
patients and their environment in the acceptance and acknowledgement of the
disease.