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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
King's College London
RECRUITING
London
Contact Information
Primary
Stephen EJ Connor, MRCP FRCR
steve.connor@nhs.net
07816882304
Backup
Irumee Pai, FRCS
irumee.pai@gstt.nhs.uk
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 16
Related Therapeutic Areas
Sponsors
Leads: King's College Hospital NHS Trust
Collaborators: Guy's and St Thomas' NHS Foundation Trust, King's College London

This content was sourced from clinicaltrials.gov

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