Imaging of Endolymphatic Hydrops at 7T MRI

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

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

No trial groups listed

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