MRI Scan and Intra-labyrinthine Schwannoma

July 11, 2018 updated by: University Hospital, Strasbourg, France

INTEREST OF INTRAVENOUS INJECTION OF GADOLINIUM IN EXPLORATION INTRA-LABYRINTHINE SCHWANNOMA IN MRI 3 TESLAS

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)

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Strasbourg, France, 67098
        • Recruiting
        • Service Imagerie 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient having intra-labyrinthine schwannoma

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 2, 2018

Primary Completion (ANTICIPATED)

February 1, 2019

Study Completion (ANTICIPATED)

February 1, 2019

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (ACTUAL)

July 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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