Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Aortic Arch and Cerebral Branches

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Cardiovascular Abnormalities

Intervention / Treatment
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* Drug: Gadopentetate dimeglumine (Magnevist)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Gadopentetate dimeglumine (Magnevist)<br>* Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded reader |  | Image creation after injection -evaluation at blind read | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic confidence |  | At blinded and/or open label read of the images | 
| Visual assessment of stenosis |  | At blinded and/or open label read of the images | 
| Difference in degree of stenosis |  | At blinded and/or open label read of the images | 
| Other diagnostic findings |  | At blinded and/or open label read of the images | 
| Location and matching of stenosis |  | At blinded and/or open label read of the images | 
| Image quality |  | At blinded and/or open label read of the images | 
| Image evaluability and presence of artifacts |  | At blinded and/or open label read of the images | 
| Ability to visualize arterial segments |  | At blinded and/or open label read of the images | 
| Proportion of correctly categorized maximum stenosis per segment |  | At blinded and/or open label read of the images | 
| Number of evaluable segments |  | At blinded and/or open label read of the images | 
| Duration if 2D TOF and CE-MRA |  | At blinded and/or open label read of the images | 
| Patient management |  | From baseline to 24 hours follow-up | 
| Safety variables |  | From baseline to 24 hours follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Structural abnormalities of the aortic arch and cerebral branches