NCT03580850

Brief Summary

Evaluate the interest of gadolinium for the positive and topographic diagnosis of intra-labyrinthine schwannoma, comparing T1 sequence acquired after gadolinium injection to a sequence of fast imaging type employing steady state acquisition (FIESTA-C)

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

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

February 2, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 13, 2018

Status Verified

February 1, 2018

Enrollment Period

12 months

First QC Date

February 26, 2018

Last Update Submit

July 11, 2018

Conditions

Schwannoma

Keywords

intra labyrinthine schwannomaschwannomamagnetic resonance imaging (MRI)gadoliniumT2 weighted gradient echo

Outcome Measures

Primary Outcomes (1)

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

    1 hour after the realization of the MRI

Interventions

No intervention in this restrospective studyOTHER

This study is an obervational study

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient having intra-labyrinthine schwannoma

You may qualify if:

  • Age 18-80 years
  • Have intra-labyrinthine schwannoma
  • Have benefited from an MRI with gadolinium injection on the MRI 3T with interpretable sequences of good quality
  • Subject giving their consent for their participation
  • Subjects who benefited, between 2009 and 2016, from an MRI of the external auditory canals, with gadolinous product injection and on the 3 Tesla MRI, in which a diagnosis of intra labyrinthine schwannoma was made

You may not qualify if:

  • \- Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Imagerie 1

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Neurilemmoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Francis VEILLON, MD, PhD

    University Hospital, Strasbourg, France

    STUDY DIRECTOR

Central Study Contacts

Francis VEILLON, MD, PhD

CONTACT

33 3 88 12 78 65Francis.veillon@chru-strasbourg.fr

Aïna VENKATASAMY, MD

CONTACT

33 3 88 12 78 65aina.venkatasamy@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

February 26, 2018

First Posted

July 9, 2018

Study Start

February 2, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

July 13, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)