Status:
RECRUITING
Imaging of Endolymphatic Hydrops at 7T MRI
Lead Sponsor:
King's College Hospital NHS Trust
Collaborating Sponsors:
King's College London
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Meniere Disease
Eligibility:
All Genders
18+ years
Brief 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 cohor...
Detailed Description
Meniere's Disease is an inner ear disease characterised by progressive, fluctuating hearing loss and dizziness. Pathologically, it is characterised by endolymphatic hydrops. The diagnosis of Meniere's...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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 Criteria:
- 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)
Exclusion
Key Trial Info
Start Date :
July 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04370366
Start Date
July 1 2023
End Date
July 1 2026
Last Update
March 6 2024
Active Locations (1)
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1
King's College London
London, United Kingdom, SW1P 4AL