Meniere's disease: a reappraisal supported by a variable latency of symptoms and the MRI visualisation of endolymphatic hydrops.
Ilmari Pyykkö, Tsutomu Nakashima, Tadao Yoshida...
https://pubmed.ncbi.nlm.nih.gov/23418296Actively Recruiting
Age: 18Years +
All Genders
ID04370366
Imaging Endolymphatic Hydrops at 7T MRI: Validation of Inner Ear Structures and Comparison of Diagnostic Outcomes with 3T MRI
Led by King's College Hospital NHS Trust · Updated on 2024-03-06
16
Participants Needed
1
Research Sites
52 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
Researchers are investigating advanced MRI techniques to improve the diagnosis of Meniere's Disease (MD), a condition characterized by fluctuating hearing loss and dizziness caused by endolymphatic hydrops (EH) in the inner ear. The study aims to compare the effectiveness of 1.5T and 3T gadolinium-enhanced MRI in diagnosing MD and to evaluate the use of 7T Sodium Imaging as a non-contrast alternative in distinguishing symptomatic from asymptomatic MD ears. Participants will undergo delayed post gadolinium enhanced MRI scans at 1.5T and 3T to assess EH using both semi-quantitative and quantitative analyses. Additionally, Sodium Imaging at 7T will be performed with semi-quantitative analysis to compare its diagnostic performance against the 3T MRI. This prospective cohort study will follow patients over 24 months, focusing on imaging outcomes without interventional treatments. During the study, participants will receive MRI scans and their inner ear structures will be analyzed for signs of EH and perilymphatic enhancement asymmetry. Researchers will measure signal intensity ratios and volumes of inner ear compartments using various MRI sequences. The primary outcomes include comparisons of diagnostic accuracy between 1.5T, 3T, and 7T MRI techniques. The study duration is approximately two years, focusing on imaging biomarkers to support MD diagnosis and guide future research and treatment strategies.
CONDITIONS
Brief Title
Imaging of Endolymphatic Hydrops at 7T MRI
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years of age or older
- Ability to understand the patient information sheet and provide written informed consent
- Unilateral audio-vestibular symptoms meeting 2015 Barany criteria for unilateral Meniere's Disease of less than 5 years duration
- Candidates for clinical MRI scanning for confirmation of Meniere's Disease as part of standard care
You will not qualify if you...
- Standard contraindications to 7T MRI
- Known allergy to gadolinium contrast
- Calculated glomerular filtration rate (GFR) less than 30 mls/min
- Previous temporal bone surgery or trauma
- Other known temporal bone pathology
- Need for early post gadolinium sequences, such as in autoimmune inner disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 2.5 years
Participants undergo MRI scans at 1.5T, 3T, and 7T to image inner ear structures and evaluate endolymphatic hydrops using contrast-enhanced and sodium imaging techniques.
Multiple MRI visits as scheduled over the study period
Long-term Monitoring
Duration - Up to 2.5 years
Participants are monitored over time to assess the progression and diagnostic outcomes related to Meniere's Disease through imaging and clinical evaluation.
Periodic follow-up visits depending on imaging schedule
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
I
Irumee Pai, FRCS
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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Published Research Related To This Trial
Imaging of endolymphatic and perilymphatic fluid at 3T after intratympanic administration of gadolinium-diethylene-triamine pentaacetic acid.
S Naganawa, M Sugiura, M Kawamura...
https://pubmed.ncbi.nlm.nih.gov/18184846Detection and grading of endolymphatic hydrops in Menière disease using MR imaging.
K Baráth, B Schuknecht, A Monge Naldi...
https://pubmed.ncbi.nlm.nih.gov/24524921MRI of endolymphatic hydrops in patients with Meniere's disease: a case-controlled study with a simplified classification based on saccular morphology.
Arnaud Attyé, Michael Eliezer, Naïla Boudiaf...
https://pubmed.ncbi.nlm.nih.gov/27999985Imaging of the saccule for the diagnosis of endolymphatic hydrops in Meniere disease, using a three-dimensional T2-weighted steady state free precession sequence: accurate, fast, and without contrast material intravenous injection.
Aïna Venkatasamy, Francis Veillon, Aude Fleury...
https://pubmed.ncbi.nlm.nih.gov/29708183Saccular measurements in routine MRI can predict hydrops in Menière's disease.
François Simon, Jean-Pierre Guichard, Romain Kania...
https://pubmed.ncbi.nlm.nih.gov/289519627-Tesla sodium magnetic resonance imaging of the inner ears in unilateral Ménière's disease and endolymphatic hydrops: an exploratory study.
Steve Connor, Peter Lally, Irumee Pai...
https://pubmed.ncbi.nlm.nih.gov/41219717