About this trial
Imaging endolymphatic hydrops with 7T Sodium Imaging and 1.5 T gadolinium enhanced imaging: a comparison of diagnostic outcomes with 3T MRI
Duration of study 24 months
Study design Prospective cohort study
Number of patients 16 patients
1. To evaluate whether imaging both 1.5T and 3T have an equivalent performance in terms of diagnosing MD ears with delayed post gadolinium enhanced MRI (applying quantitative and semi-quantitative analysis) 2. To compare the diagnostic performance of Sodium Imaging at 7T (applying semi-quantitative analysis) with that of delayed post gadolinium enhanced 3T MRI in distinguishing symptomatic from asymptomatic Meniere's Disease (MD) ears.
Eligibility criteria
Qualifiers
Male or female, 18 years of age or older
The capacity to understand the patient information sheet and the ability to provide written informed consent
Unilateral audio-vestibular symptoms which satisfy 2015 Barany criteria for unilateral Meniere's Disease of less than 5 years duration
Would be offered clinical MRI scanning for confirmation of a Meniere's disease diagnosis as part of standard of care
Disqualifiers
Standard contraindications to 7T MRI
Known allergy to Gadolinium contrast
Calculated GFR < 30 mls/min
Previous temporal bone surgery or trauma
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
King's College Hospital NHS Trust
Lead sponsor
King's College London
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator