Secondary Endolymphatic Hydrops and Vestibular Schwannomas on 3 Tesla MRI

Vestibular Schwannoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03593577
• Other study ID #: 7025
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: June 2019

Study information

• Verified date: June 2018
• Source: University Hospital, Strasbourg, France
• Contact: Aïna VENKATASAMY,, MD
• Phone: 33 3 88 12 78 65
• Email: aina.venkatasamy[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 185
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Endolymphatic Hydrops
• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Locations

Country	Name	City	State
France	Service Imagerie 1	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of height and width of the saccule on MRI.		1 hour after the realization of the MRI