- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00310609
Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Aortic Arch and Cerebral Branches
December 29, 2014 updated by: Bayer
Multicenter, Open-label Study of the Safety (Open-label) and Efficacy (Open-label and Blinded Reader) of a Single Administration of Approximately 0.1 mmol/kg of Magnevist® Injection-enhanced Magnetic Resonance Arteriography (MRA) and 2-dimensional-time-of-flight (2D-TOF) MRA in Patients With Known or Suspected Disease of the Aortic Arch and Cerebral Branches Who Are Undergoing MRA of These Vessels With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as the Standard of Reference.
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the aortic arch and cerebral branches.
The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Study Type
Interventional
Enrollment (Actual)
123
Phase
- Phase 3
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Has known or suspected disease of the aortic arch and cerebral branches
- Is scheduled for X-ray angiography
Exclusion Criteria:
- Has any contraindication to magnetic resonance imaging
- Is scheduled for any procedure before the X-ray angiography
- Had previous bilateral intervention (surgery, bypass) of the arteries of interest
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
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
|
Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded reader
Time Frame: Image creation after injection -evaluation at blind read
|
Image creation after injection -evaluation at blind read
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diagnostic confidence
Time Frame: At blinded and/or open label read of the images
|
At blinded and/or open label read of the images
|
Visual assessment of stenosis
Time Frame: At blinded and/or open label read of the images
|
At blinded and/or open label read of the images
|
Difference in degree of stenosis
Time Frame: At blinded and/or open label read of the images
|
At blinded and/or open label read of the images
|
Other diagnostic findings
Time Frame: At blinded and/or open label read of the images
|
At blinded and/or open label read of the images
|
Location and matching of stenosis
Time Frame: At blinded and/or open label read of the images
|
At blinded and/or open label read of the images
|
Image quality
Time Frame: At blinded and/or open label read of the images
|
At blinded and/or open label read of the images
|
Image evaluability and presence of artifacts
Time Frame: At blinded and/or open label read of the images
|
At blinded and/or open label read of the images
|
Ability to visualize arterial segments
Time Frame: At blinded and/or open label read of the images
|
At blinded and/or open label read of the images
|
Proportion of correctly categorized maximum stenosis per segment
Time Frame: At blinded and/or open label read of the images
|
At blinded and/or open label read of the images
|
Number of evaluable segments
Time Frame: At blinded and/or open label read of the images
|
At blinded and/or open label read of the images
|
Duration if 2D TOF and CE-MRA
Time Frame: At blinded and/or open label read of the images
|
At blinded and/or open label read of the images
|
Patient management
Time Frame: From baseline to 24 hours follow-up
|
From baseline to 24 hours follow-up
|
Safety variables
Time Frame: From baseline to 24 hours follow-up
|
From baseline to 24 hours follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2003
Study Completion (Actual)
October 1, 2004
Study Registration Dates
First Submitted
March 31, 2006
First Submitted That Met QC Criteria
March 31, 2006
First Posted (Estimate)
April 4, 2006
Study Record Updates
Last Update Posted (Estimate)
December 30, 2014
Last Update Submitted That Met QC Criteria
December 29, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90941
- 304630
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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