Imaging of Endolymphatic Hydrops at 7T MRI
ConditionMeniere Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKing's College Hospital NHS Trust
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
This trial does not accept healthy volunteersQualifiers
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 population
Secondary care. Otology and audio-vestibular clinics Guy's and St Thomas' hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The qualitative asymmetry of perilymphatic enhancement and the quantitative signal intensity ratio of the cochlea with delayed post gadolinium 3T and 1.5T.
Time frame
2.5 years2
The semi-quantitative scoring of endolymphatic hydrops and the quantitative volume of endolymphatic and perilymphatic structures with delayed post gadolinium 3T and 1.5T.
Time frame
2.5 years3
Semi-quantitative analysis (including ratios to internal references and the contralateral ear) of the vestibule on Sodium Imaging at 7T
Time frame
2.5 yearsSponsors and contacts
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King's College Hospital NHS Trust
Lead sponsor
King's College London
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov