Evolution of Cochleovestibular Schwannomas

Evolution of Cochleovestibular Schwannomas in the Internal Auditory Canal by Volume Measering With aTeslas MRI 3

Investigators want to know the natural history of the vestibular schwannomas: increasing, decreasing or stability, by monitoring more than 3 MRIs during a span of more than 2 years. They will obtain 3 groups: the volume increasing schwannomas which will be the most important group, the schwannomas that will be stable and a small group where the schwannomas will decrease.

The secondary purpose is that the investigators want to know the threshold values: a minimum volume under which we are sure that the schwannoma will not increase, a maximum value where it will increase and if its evolution can be correlated to clinical or radiological criteria.

Study Overview

• Status: Unknown
• Conditions: Schwannoma

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

Study Locations

• France
  • Strasbourg
    • Srtrasbourg, Strasbourg, France, 67091
      • Recruiting
      • Service Imagerie 1
      • Sub-Investigator: Julien UTTNER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients having a typical vestibular schwannoma diagnosis during the first MRI, having a minimum of 3 internal auditory canal MRIs on the same machine (Signa HDxt, General Electric, Strasbourg, France) ) at the Hôpitaux Universitaires de Strasbourg

Description

Inclusion Criteria:

• Age over 18 years
• having a typical vestibular schwannoma diagnosis during the first MRI, having a minimum of 3 internal auditory canal MRIs on the same machine (Signa HDxt, General Electric, Strasbourg, France) ) at the Hôpitaux Universitaires de Strasbourg
• patients consenting to participate

Exclusion Criteria:

• intra-labyrinthical extension
• treatment before the 3 MRIs
• no injection of gadolinium
• atypical diagnosis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence or absence of intra labyrinthine vestibular nerve tumor using T2 FIESTA	1 hour after the realization of the MRI

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: schwannoma; intra labyrinthine schwannoma; cochleovestibular schwannomas; cochleovestibular
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nerve Sheath Neoplasms; Neuroma; Neurilemmoma
• Other Study ID Numbers: 7560

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No