RecruitingNCT04370366

Imaging of Endolymphatic Hydrops at 7T MRI

Imaging Endolymphatic Hydrops at 7T MRI: Validation of Internal Inner Ear Structures on T2w Imaging as Markers of Endolymphatic Hydrops and a Comparison of Diagnostic Outcomes With 3T MRI


Sponsor

King's College Hospital NHS Trust

Enrollment

16 participants

Start Date

Jul 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria6

  • Standard contraindications to 7T MRI
  • Known allergy to Gadolinium contrast
  • Calculated GFR \< 30 mls/min
  • Previous temporal bone surgery or trauma
  • Other known temporal bone pathology
  • Requirement for early post gadolinium sequences (e.g. autoimmune inner disease as a differential diagnosis)

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Locations(1)

King's College London

London, United Kingdom

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NCT04370366


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