Imaging of Endolymphatic Hydrops at 7T MRI (NCT04370366) | Clinical Trial Compass
UnknownNot Applicable
Imaging of Endolymphatic Hydrops at 7T MRI
United Kingdom16 participantsStarted 2023-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The qualitative asymmetry of perilymphatic enhancement and the quantitative signal intensity ratio of the cochlea with delayed post gadolinium 3T and 1.5T.
Timeframe: 2.5 years
2
The semi-quantitative scoring of endolymphatic hydrops and the quantitative volume of endolymphatic and perilymphatic structures with delayed post gadolinium 3T and 1.5T.
Timeframe: 2.5 years
3
Semi-quantitative analysis (including ratios to internal references and the contralateral ear) of the vestibule on Sodium Imaging at 7T