Scleral Hydrops and Intralabyrinthine Schwannoma

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Unknown status
CT.gov ID
NCT03581396
Collaborator
(none)
30
1
11.3
2.7

Study Details

Study Description

Brief Summary

The symptoms of intralabyrinthine schwannomas (vertigo, deafness, instability, tinnitus) cut across the symptoms found in pressure pathologies involving the inner ear, particularly the endolymphatic hydrops.

Some publications have described dilatation of the membranous labyrinth (hydrops) in the presence of intralabyrinthine tumors.

It would be interesting to measure the size of the saccule (structure of the membranous labyrinth) in the presence of an intralabyrinthine schwannoma, to evaluate if some of the symptoms presented by the patients could be explained by the concomitant presence of an endolymphatic hydrops (accessible to drug therapy - Betahistine).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Scleral Hydrops and Intralabyrinthine Schwannoma
    Actual Study Start Date :
    Jun 22, 2018
    Anticipated Primary Completion Date :
    Jun 1, 2019
    Anticipated Study Completion Date :
    Jun 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Size of intralabyrinth saccules [1 hour after the realization of the MRI]]

      To measure saccule size (membranous labyrinth structure) in patients with intralabyrinthine schwannoma on a high resolution fluid sequence (FIESTA-C) in 3T MRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Age> 18,

    • Subject having benefited from an exploration of internal auditory canals by MRI in our service at CHU de Hautepierre between January 1, 2008 and October 1, 2017

    • Presence on the MRI of the internal auditory ducts, including the realization of a high resolution fluid sequence of FIESTA-C (exploitable) type, of an intralabyrinthine schwannoma, without extension to the internal auditory canal.

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

    Criteria for Non Inclusion

    • Refusal of the patient to participate in the study

    • Absence of high resolution fluid sequence of fast imaging employing steady state acquisition (FIESTA-C)

    • Presence of movement artifacts interfering with the interpretation of the FIESTA-C sequence

    • Interior surgery of the inner ear or pontocerebellar angle, without preoperative imaging Inflammatory or infectious pathology of the concomitant middle or inner ear

    • Extension of schwannoma to the internal auditory canal

    • 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:
    NCT03581396
    Other Study ID Numbers:
    • 7026
    First Posted:
    Jul 10, 2018
    Last Update Posted:
    Jul 10, 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 10, 2018