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Search / Trial NCT04370366

Imaging of Endolymphatic Hydrops at 7T MRI

Launched by KING'S COLLEGE HOSPITAL NHS TRUST · Apr 29, 2020

Trial Information

Current as of April 30, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to diagnose Meniere's Disease, a condition that affects balance and hearing, by using advanced imaging techniques. Specifically, the study will compare two types of MRI scans: a standard one using a contrast dye called gadolinium and a newer method called Sodium Imaging. The goal is to find out if the new Sodium Imaging at a higher strength (7T) is better at identifying the condition compared to the traditional gadolinium-enhanced imaging at lower strengths (1.5T and 3T).

To participate in this trial, you need to be at least 18 years old and have symptoms of Meniere's Disease that have lasted less than five years. You should also be able to understand the information provided and give your consent to participate. This study will last for 24 months, and if you qualify, you can expect to undergo different types of MRI scans as part of the evaluation. It's important to note that certain medical conditions or previous surgeries may exclude you from participating. Overall, this trial aims to improve the diagnosis of Meniere's Disease, which can lead to better treatment options for patients.

Gender

ALL

Eligibility 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)

About King's College Hospital Nhs Trust

King's College Hospital NHS Trust is a leading healthcare institution in the United Kingdom, renowned for its commitment to providing high-quality patient care and advancing medical research. With a strong emphasis on clinical excellence, the Trust supports a wide range of clinical trials across various specialties, leveraging its state-of-the-art facilities and a multidisciplinary team of healthcare professionals. By fostering innovation and collaboration, King's College Hospital NHS Trust aims to enhance treatment options and improve outcomes for patients, while contributing to the global body of medical knowledge through rigorous scientific investigation.

Locations

London, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Stephen EJ Connor, MRCP FRCR

Principal Investigator

King's College Hospital NHS Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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