Secondary Endolymphatic Hydrops and Vestibular Schwannomas on 3 Tesla MRI

NCT03593577 | Unknown

• 1 other identifier: 7025
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma

Keywords

Schwannoma; saccular dilatation; endolymphatic hydrops; magnetic resonnance imaging; vertigo

Outcome Measures

Primary Outcomes (1)

• Presence or absence of height and width of the saccule on MRI.

  1 hour after the realization of the MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient 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,

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service Imagerie 1

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Neuroma, Acoustic; Neurilemmoma; Endolymphatic Hydrops; Vertigo

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Labyrinth Diseases; Vestibular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aïna VENKATASAMY,, MD

CONTACT

33 3 88 12 78 65; aina.venkatasamy@chru-strasbourg.fr

Aurélie KARCH-GEORGES, MD

CONTACT

33 3 88 12 78 65; aurelie.karch@chru-strasbourg.fr

Study Design

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

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 20, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 20, 2018

Record last verified: 2018-06

Locations

FR (1)