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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00310609
• Collaborator: (none)
• Enrollment: 123
• Arm: 1
• Duration (Months): 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Abnormalities	Drug: Gadopentetate dimeglumine (Magnevist)	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 123 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official 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.
• Study Start Date: Dec 1, 2003
• Actual Study Completion Date: Oct 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Gadopentetate dimeglumine (Magnevist); Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day

Outcome Measures

Primary Outcome Measures

1. 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

1. Diagnostic confidence [At blinded and/or open label read of the images]

2. Visual assessment of stenosis [At blinded and/or open label read of the images]

3. Difference in degree of stenosis [At blinded and/or open label read of the images]

4. Other diagnostic findings [At blinded and/or open label read of the images]

5. Location and matching of stenosis [At blinded and/or open label read of the images]

6. Image quality [At blinded and/or open label read of the images]

7. Image evaluability and presence of artifacts [At blinded and/or open label read of the images]

8. Ability to visualize arterial segments [At blinded and/or open label read of the images]

9. Proportion of correctly categorized maximum stenosis per segment [At blinded and/or open label read of the images]

10. Number of evaluable segments [At blinded and/or open label read of the images]

11. Duration if 2D TOF and CE-MRA [At blinded and/or open label read of the images]

12. Patient management [From baseline to 24 hours follow-up]

13. Safety variables [From baseline to 24 hours follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00310609
• Other Study ID Numbers: 90941; 304630
• First Posted: Apr 4, 2006
• Last Update Posted: Dec 30, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Bayer: Structural abnormalities of the aortic arch and cerebral branches
• Additional relevant MeSH terms: Cardiovascular Abnormalities; Congenital Abnormalities

Study Results

No Results Posted as of Dec 30, 2014