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Completed

NCT Number: NCT00310609

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

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.

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Key information

Conditions

Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gadopentetate dimeglumine (Magnevist)

Drug

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

Primary outcomes

  1. Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded reader

    Time frame: Image creation after injection -evaluation at blind read

Secondary outcomes

  1. Diagnostic confidence

    Time frame: At blinded and/or open label read of the images

  2. Visual assessment of stenosis

    Time frame: At blinded and/or open label read of the images

  3. Difference in degree of stenosis

    Time frame: At blinded and/or open label read of the images

  4. Other diagnostic findings

    Time frame: At blinded and/or open label read of the images

  5. Location and matching of stenosis

    Time frame: At blinded and/or open label read of the images

  6. Image quality

    Time frame: At blinded and/or open label read of the images

  7. Image evaluability and presence of artifacts

    Time frame: At blinded and/or open label read of the images

  8. Ability to visualize arterial segments

    Time frame: At blinded and/or open label read of the images

  9. Proportion of correctly categorized maximum stenosis per segment

    Time frame: At blinded and/or open label read of the images

  10. Number of evaluable segments

    Time frame: At blinded and/or open label read of the images

  11. Duration if 2D TOF and CE-MRA

    Time frame: At blinded and/or open label read of the images

  12. Patient management

    Time frame: From baseline to 24 hours follow-up

  13. Safety variables

    Time frame: From baseline to 24 hours follow-up

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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.

Important dates

Study start
2003
Study completion
2004
First posted
Apr 4, 2006
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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