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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
83
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)
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)
Unnamed facility
Chengdu, Sichuan, China
Unnamed facility
Beijing, China
Unnamed facility
Shanghai, China
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.
Time frame: 20-30 seconds after injection
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.
Time frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
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.
Time frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
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.
Time frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
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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.
Time frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
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.
Time frame: 20-30 seconds after injection
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.
Time frame: 20-30 seconds after injection
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.
Time frame: 20-30 seconds after injection
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.
Time frame: 20-30 seconds after injection