Back to resultsEfficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
Primary Purpose
Central Nervous System Diseases
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Magnevist
Sponsored by
About this trial
This is an interventional diagnostic trial for Central Nervous System Diseases focused on measuring Gadovist, Gadavist, Contrast agent, Brain, Spine disease, Magnetic Resonance Imaging
Eligibility Criteria
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
Sites / Locations
- Jiangsu Province Hospital
- The 1st Affiliated Hosp of the 4th Military Med Uni
- Chinese PLA General Hosp.
- Fudan University Huashan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875)
GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)
Arm Description
Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00395460
Brief Title
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 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 brain or spine 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
Central Nervous System Diseases
Keywords
Gadovist, Gadavist, Contrast agent, Brain, Spine disease, Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875)
Arm Type
Experimental
Arm Description
Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
Arm Title
GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention Description
1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW)
Intervention Type
Drug
Intervention Name(s)
Magnevist
Intervention Description
0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)
Primary Outcome Measure Information:
Title
Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions
Description
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.
Time Frame
Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Secondary Outcome Measure Information:
Title
Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan
Description
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).
Time Frame
Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Title
Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment
Description
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).
Time Frame
Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Title
Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI
Description
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).
Time Frame
Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Title
Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions
Description
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).
Time Frame
Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Other Pre-specified Outcome Measures:
Title
Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases
Description
CNR = (SI lesion - SI normal tissue) / 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.
Time Frame
Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Title
Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases
Description
CNR = (SI lesion - SI normal tissue) / 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.
Time Frame
Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Title
Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases
Description
Investigators and blinded readers (reader 2, 3 and 4) were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.
Time Frame
Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Title
Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases
Description
Investigators and blinded readers (reader 2, 3 and 4= were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.
Time Frame
Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
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, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The 1st Affiliated Hosp of the 4th Military Med Uni
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Chinese PLA General Hosp.
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Fudan University Huashan Hospital
City
Shanghai
ZIP/Postal Code
200040
Country
China
12. IPD Sharing Statement
Citations:
Citation
Liang Z; Ma L; Wang D; Huan Y; Li P; Yu J; Yao Z; Chen S; He H; Feng X and Breuer J. Efficacy and Safety of Gadobutrol (1.0 M) versus Gadopentetate Dimeglumine (0.5 M) for Enhanced MRI of CNS Lesions: A Phase III, Multicenter, SingleBlind, Randomized Study in Chinese Patients. Magnetic Resonance Insights 2012; 5:17-28
Results Reference
result
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Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
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