Actively Recruiting

Age: 18Years +
All Genders
NCT04370366

Imaging of Endolymphatic Hydrops at 7T MRI

Led by King's College Hospital NHS Trust · Updated on 2024-03-06

16

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

K

King's College Hospital NHS Trust

Lead Sponsor

K

King's College London

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Imaging of Endolymphatic Hydrops at 7T MRI

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, 18 years of age or older
  • Ability to understand patient information and provide written informed consent
  • Unilateral audio-vestibular symptoms meeting 2015 Barany criteria for unilateral Meniere's Disease of less than 5 years duration
  • Scheduled for clinical MRI scanning to confirm Meniere's Disease diagnosis as part of standard care
Not Eligible

You will not qualify if you...

  • Standard contraindications to 7T MRI
  • Known allergy to gadolinium contrast
  • Calculated glomerular filtration rate (GFR) less than 30 ml/min
  • Previous temporal bone surgery or trauma
  • Other known temporal bone pathology
  • Need for early post gadolinium sequences (e.g., autoimmune inner ear disease)

AI-Screening

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Trial Site Locations

Total: 1 location

1

King's College London

London, United Kingdom, SW1P 4AL

Actively Recruiting

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Research Team

S

Stephen EJ Connor, MRCP FRCR

CONTACT

I

Irumee Pai, FRCS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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