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
Overview
- Phase
- Phase 3
- Intervention
- Gadobutrol (Gadavist, Gadovist, BAY86-4875)
- Conditions
- Vascular Diseases
- Sponsor
- Bayer
- Enrollment
- 83
- Primary Endpoint
- Number of Vessel Segments Visualized With Diagnostic Quality
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Arms & Interventions
Gadobutrol, then Gadopentate dimeglumine
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
Intervention: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Gadobutrol, then Gadopentate dimeglumine
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
Intervention: Gadopentate dimeglumine (Magnevist, BAY86-4882)
Gadopentate, dimeglumine then Gadobutrol
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: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Gadopentate, dimeglumine then Gadobutrol
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: Gadopentate dimeglumine (Magnevist, BAY86-4882)
Outcomes
Primary Outcomes
Number of Vessel Segments Visualized With Diagnostic Quality
Time Frame: 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 Outcomes
- MRA Diagnosis by Blinded Reader 1(20-30 seconds after injection)
- 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))
- Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator(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(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(immediately before and 20-30 seconds after injection (precontrast and postcontrast))
- MRA Diagnosis by Investigators(20-30 seconds after injection)
- MRA Diagnosis by Blinded Reader 2(20-30 seconds after injection)
- MRA Diagnosis by Blinded Reader 3(20-30 seconds after injection)