Evolution of Cochleovestibular Schwannomas

Schwannoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04417868
• Other study ID #: 7560
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: July 2020

Study information

• Verified date: June 2020
• 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurilemmoma
• Schwannoma

Locations

Country	Name	City	State
France	Service Imagerie 1	Srtrasbourg	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 intra labyrinthine vestibular nerve tumor using T2 FIESTA		1 hour after the realization of the MRI