Imaging of Endolymphatic Hydrops at 7T MRI

NCT04370366 | Recruiting

• 1 other identifier: 259867
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Meniere Disease

Outcome Measures

Primary Outcomes (3)

• The qualitative asymmetry of perilymphatic enhancement and the quantitative signal intensity ratio of the cochlea with delayed post gadolinium 3T and 1.5T.

  2.5 years

• The semi-quantitative scoring of endolymphatic hydrops and the quantitative volume of endolymphatic and perilymphatic structures with delayed post gadolinium 3T and 1.5T.

  2.5 years

• Semi-quantitative analysis (including ratios to internal references and the contralateral ear) of the vestibule on Sodium Imaging at 7T

  2.5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Secondary care. Otology and audio-vestibular clinics Guy's and St Thomas' hospital

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

King's College London

London, SW1P 4AL, United Kingdom

RECRUITING

Related Publications (7)

• Pyykko I, Nakashima T, Yoshida T, Zou J, Naganawa S. Meniere's disease: a reappraisal supported by a variable latency of symptoms and the MRI visualisation of endolymphatic hydrops. BMJ Open. 2013 Feb 14;3(2):e001555. doi: 10.1136/bmjopen-2012-001555. Print 2013.

  PMID: 23418296 BACKGROUND

• Naganawa S, Sugiura M, Kawamura M, Fukatsu H, Sone M, Nakashima T. Imaging of endolymphatic and perilymphatic fluid at 3T after intratympanic administration of gadolinium-diethylene-triamine pentaacetic acid. AJNR Am J Neuroradiol. 2008 Apr;29(4):724-6. doi: 10.3174/ajnr.A0894. Epub 2008 Jan 9.

  PMID: 18184846 BACKGROUND

• Barath K, Schuknecht B, Naldi AM, Schrepfer T, Bockisch CJ, Hegemann SC. Detection and grading of endolymphatic hydrops in Meniere disease using MR imaging. AJNR Am J Neuroradiol. 2014 Jul;35(7):1387-92. doi: 10.3174/ajnr.A3856. Epub 2014 Feb 13.

  PMID: 24524921 BACKGROUND

• Attye A, Eliezer M, Boudiaf N, Tropres I, Chechin D, Schmerber S, Dumas G, Krainik A. MRI of endolymphatic hydrops in patients with Meniere's disease: a case-controlled study with a simplified classification based on saccular morphology. Eur Radiol. 2017 Aug;27(8):3138-3146. doi: 10.1007/s00330-016-4701-z. Epub 2016 Dec 20.

  PMID: 27999985 BACKGROUND

• Venkatasamy A, Veillon F, Fleury A, Eliezer M, Abu Eid M, Romain B, Vuong H, Rohmer D, Charpiot A, Sick H, Riehm S. Imaging 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. Eur Radiol Exp. 2017;1(1):14. doi: 10.1186/s41747-017-0020-7. Epub 2017 Oct 9.

  PMID: 29708183 BACKGROUND

• Simon F, Guichard JP, Kania R, Franc J, Herman P, Hautefort C. Saccular measurements in routine MRI can predict hydrops in Meniere's disease. Eur Arch Otorhinolaryngol. 2017 Dec;274(12):4113-4120. doi: 10.1007/s00405-017-4756-8. Epub 2017 Sep 26.

  PMID: 28951962 BACKGROUND

• Connor S, Lally P, Pai I, Brnawi H, Touska P, Ourselin S, Hajnal JV. 7-Tesla sodium magnetic resonance imaging of the inner ears in unilateral Meniere's disease and endolymphatic hydrops: an exploratory study. BMC Med Imaging. 2025 Nov 11;25(1):454. doi: 10.1186/s12880-025-01986-6.

  PMID: 41219717 DERIVED

MeSH Terms

Conditions

Meniere Disease

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Stephen EJ Connor, MRCP FRCR

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen EJ Connor, MRCP FRCR

CONTACT

07816882304; steve.connor@nhs.net

Irumee Pai, FRCS

CONTACT

irumee.pai@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: April 30, 2020
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

GB (1)