Hydrops Saccular Clinical Trial
Official title:
Scleral Hydrops and Intralabyrinthine Schwannoma
| NCT number | NCT03581396 |
| Other study ID # | 7026 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 22, 2018 |
| Est. completion date | June 2019 |
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).
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | June 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service Imagerie 1 | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Size of intralabyrinth saccules | To measure saccule size (membranous labyrinth structure) in patients with intralabyrinthine schwannoma on a high resolution fluid sequence (FIESTA-C) in 3T MRI | 1 hour after the realization of the MRI] |