Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
- Conditions
- Vascular Diseases
- Interventions
- Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)
- Registration Number
- NCT00395733
- Lead Sponsor
- Bayer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- Chinese origin
- Known or suspected blood vessel diseases
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Gadobutrol, then Gadopentate dimeglumine Gadopentate dimeglumine (Magnevist, BAY86-4882) 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 Gadopentate, dimeglumine then Gadobutrol Gadopentate dimeglumine (Magnevist, BAY86-4882) 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 Gadobutrol, then Gadopentate dimeglumine Gadobutrol (Gadavist, Gadovist, BAY86-4875) 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 Gadopentate, dimeglumine then Gadobutrol Gadobutrol (Gadavist, Gadovist, BAY86-4875) 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
- Primary Outcome Measures
Name Time Method Number of Vessel Segments Visualized With Diagnostic Quality 20-30 seconds after injection 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
Name Time Method MRA Diagnosis by Blinded Reader 1 20-30 seconds after injection 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.
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator immediately before and 20-30 seconds after injection (precontrast and postcontrast) 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 3 immediately before and 20-30 seconds after injection (precontrast and postcontrast) 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.
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 immediately before and 20-30 seconds after injection (precontrast and postcontrast) 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 immediately before and 20-30 seconds after injection (precontrast and postcontrast) 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.
MRA Diagnosis by Investigators 20-30 seconds after injection 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 20-30 seconds after injection 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 20-30 seconds after injection 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.