- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03580850
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
Intervention / Treatment
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
-
-
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6809
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.