NCT04417868

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.5 years

First QC Date

June 2, 2020

Last Update Submit

June 10, 2020

Conditions

Schwannoma

Keywords

schwannomacochleovestibular schwannomascochleovestibularintra labyrinthine schwannoma

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of intra labyrinthine vestibular nerve tumor using T2 FIESTA

    1 hour after the realization of the MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Imagerie 1

Srtrasbourg, Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Neurilemmoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve Tissue

Central Study Contacts

Aïna VENKATASAMY, MD

CONTACT

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

Saïd CHAYER, PhD, HDR

CONTACT

33 3 88 11 66 90said.chayer@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 2, 2020

First Posted

June 5, 2020

Study Start

January 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

FR(1)