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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00310609

Enrollment

123

Registered

2006-04-04

Start date

2003-12-31

Completion date

2004-10-31

Last updated

2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Abnormalities

Keywords

Structural abnormalities of the aortic arch and cerebral branches

Brief summary

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

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.

Interventions

DRUGGadopentetate dimeglumine (Magnevist)

Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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
Diagnostic confidence	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
Ability to visualize arterial segments	At blinded and/or open label read of the images

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026