Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.

Detailed Description
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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.

Official Title
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A Single-blind, Multicenter, Randomized, Phase III Study of the Efficacy and Safety of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent for Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions in Chinese Patients

Conditions
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Central Nervous System Diseases

Intervention / Treatment
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* Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
* Drug: Magnevist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese origin, with known or suspected brain or spine 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875)<br>Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec) | Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)<br>* 1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW)<br>|
| Active Comparator: GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)<br>Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec | Drug: Magnevist<br>* 0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions | CNR = (signal intensity [SI] lesion - SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background. | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan | The number of lesions in the magnetic resonance scans was recorded before and after injection of contrast agent for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4). | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) | 
| Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment | The change in diagnostic confidence was assessed based on post-contrast compared to pre-contrast scans as improved, unchanged or worsened for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4). | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) | 
| Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI | The degree of contrast enhancement was recorded on a 4-point scale as follows: 1 = No: lesion is not enhanced. 2 = Moderate: lesion is weakly enhanced. 3 = Good: lesion is clearly enhanced. 4 = Excellent: lesion is clearly and brightly enhanced. In case of more than one lesion, the lesion with maximum enhancement was to be assessed. The change in lesion contrast enhancement was assessed based on post-contrast in comparison to pre-contrast scans for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4). | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) | 
| Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions | Lesion delineation was recorded on a 4-point scale as follows: 1 = None: no or unclear delineation of the boundary between lesion and surrounding tissue; 2 = Moderate: some aspects of border delineation covered; 3 = Good: almost clear delineation, but not complete on relevant slices; 4 = Excellent: sharp and complete delineation. In case of more than one lesion, the lesion with maximum enhancement was assessed. Change in lesion delineation was assessed based on post-contrast in comparison to pre-contrast scans for investigators and all 3 blinded readers (reader 2, reader 3 and reader 4). | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gadovist, Gadavist, Contrast agent, Brain, Spine disease, Magnetic Resonance Imaging