Imaging endolymphatic hydrops in Meniere's Disease using advanced MRI techniques
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
This study is testing if advanced MRI techniques can help doctors better identify Meniere's Disease in people with hearing and balance issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04370366 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the diagnostic performance of 7T Sodium Imaging compared to 1.5T and 3T gadolinium-enhanced MRI in patients with Meniere's Disease. It will involve a prospective cohort of 16 patients who meet specific criteria for unilateral audio-vestibular symptoms. The study will assess whether the advanced imaging techniques can reliably distinguish between symptomatic and asymptomatic cases of the disease. The duration of the study is set for 24 months, focusing on improving diagnostic accuracy for this elusive condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unilateral audio-vestibular symptoms consistent with Meniere's Disease lasting less than five years.
Not a fit: Patients with standard contraindications to 7T MRI or those with known allergies to gadolinium contrast may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of Meniere's Disease, allowing for better-targeted treatments.
How similar studies have performed: While advanced imaging techniques for Meniere's Disease are being explored, this specific approach using 7T Sodium Imaging is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
London
- King's College London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Stephen EJ Connor, MRCP FRCR — King's College Hospital NHS Trust
- Study coordinator: Stephen EJ Connor, MRCP FRCR
- Email: steve.connor@nhs.net
- Phone: 07816882304
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.