Back to resultsEfficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
Primary Purpose
Vascular Diseases
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Gadopentate dimeglumine (Magnevist, BAY86-4882)
Sponsored by
About this trial
This is an interventional diagnostic trial for Vascular Diseases focused on measuring Gadovist, Gadavist, MRI Imaging, vascular diseases, Chinese
Eligibility Criteria
Inclusion Criteria:
- Chinese origin
- Known or suspected blood vessel diseases
Exclusion Criteria:
- Pregnancy
- Lactation
- Conditions interfering with MRI
- Allergy to any contrast agent or any drugs
- Participation in other trial
- Require emergency treatment
- Severely impaired liver and kidney functions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Gadobutrol, then Gadopentate dimeglumine
Gadopentate, dimeglumine then Gadobutrol
Arm Description
Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged
Period 1: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged; Period 2: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged
Outcomes
Primary Outcome Measures
Number of Vessel Segments Visualized With Diagnostic Quality
Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.
Secondary Outcome Measures
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator
The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1
Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2
Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3
Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
MRA Diagnosis by Investigators
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
MRA Diagnosis by Blinded Reader 1
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
MRA Diagnosis by Blinded Reader 2
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
MRA Diagnosis by Blinded Reader 3
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00395733
Brief Title
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
Official Title
A Single-blind, Intra-individual, Crossover, Multicenter Study of the Efficacy, Safety and Tolerability of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent in the Enhanced Magnetic Resonance Angiography (MRA) in Chinese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases
Keywords
Gadovist, Gadavist, MRI Imaging, vascular diseases, Chinese
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gadobutrol, then Gadopentate dimeglumine
Arm Type
Experimental
Arm Description
Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged
Arm Title
Gadopentate, dimeglumine then Gadobutrol
Arm Type
Experimental
Arm Description
Period 1: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged; Period 2: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged
Intervention Type
Drug
Intervention Name(s)
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention Description
Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Intervention Type
Drug
Intervention Name(s)
Gadopentate dimeglumine (Magnevist, BAY86-4882)
Intervention Description
Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Primary Outcome Measure Information:
Title
Number of Vessel Segments Visualized With Diagnostic Quality
Description
Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.
Time Frame
20-30 seconds after injection
Secondary Outcome Measure Information:
Title
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator
Description
The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Time Frame
immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Title
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1
Description
Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Time Frame
immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Title
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2
Description
Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Time Frame
immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Title
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3
Description
Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Time Frame
immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Title
MRA Diagnosis by Investigators
Description
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
Time Frame
20-30 seconds after injection
Title
MRA Diagnosis by Blinded Reader 1
Description
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
Time Frame
20-30 seconds after injection
Title
MRA Diagnosis by Blinded Reader 2
Description
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
Time Frame
20-30 seconds after injection
Title
MRA Diagnosis by Blinded Reader 3
Description
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
Time Frame
20-30 seconds after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chinese origin
Known or suspected blood vessel diseases
Exclusion Criteria:
Pregnancy
Lactation
Conditions interfering with MRI
Allergy to any contrast agent or any drugs
Participation in other trial
Require emergency treatment
Severely impaired liver and kidney functions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
City
Beijing
ZIP/Postal Code
100853
Country
China
City
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
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Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
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