Secondary Endolymphatic Hydrops and Vestibular Schwannomas on 3 Tesla MRI

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Unknown status
CT.gov ID
NCT03593577
Collaborator
(none)
185
1
12
15.4

Study Details

Study Description

Brief Summary

Endolymphatic hydrops is well known of the lay public in its primary form that is Ménière disease. Nowadays, the best w ay to approach it in vivo, is to use magnetic resonance imaging (MRI).

However, endolymphatic hydrops don't limit itself to its primary form but cover a whole range of pathologies.

The hypothesis is that patients with vestibular schwannomas are more likely to develop secondary saccular hydrops.

The aim is to compare high-resolution T2-weighted images of the saccule in patients followed up for vestibular schwannomas with healthy volunteers and histological sections from cadavers in order to identify its changes.

The secondary purpose of The protocol is to determine if vestibular and audiometric abnormalities could be related to this secondary hydrops more specifically than to the tumor size and localisation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    185 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Saccular Dilatation, Endolymphatic Hydrops and Vestibular Schwannoma : is Vertigo Really Correlated to the Tumor ? A Retrospective Study Based on FIESTA-C Sequence Using a 3 Tesla MRI
    Actual Study Start Date :
    Jun 1, 2018
    Anticipated Primary Completion Date :
    Jun 1, 2019
    Anticipated Study Completion Date :
    Jun 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Presence or absence of height and width of the saccule on MRI. [1 hour after the realization of the MRI]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Age> 18,

    • Subject having benefited from an MRI with T2 high-resolution 3D sequence (FIESA) in the context of the diagnosis of vestibular schwannoma between 2008 and 2017 at the University Hospitals of Strasbourg,

    • Subject who has agreed to the use of medical data for the purposes of this research.

    Exclusion Criteria:
    • Refusal of the patient to participate in the study

    • Insufficient imaging data,

    • Tumors already treated,

    • Atypical tumors with uncertain diagnosis, intra-labrinthic or intra-labyrinthine schwannomas, concomitant infectious or inflammatory pathology in the middle or inner ear.

    • Impossibility of giving the subject informed information (difficulty understanding the subject,)

    • Subject under the protection of justice

    • Subject under guardianship or curatorship

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service Imagerie 1 Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT03593577
    Other Study ID Numbers:
    • 7025
    First Posted:
    Jul 20, 2018
    Last Update Posted:
    Jul 20, 2018
    Last Verified:
    Jun 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2018