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| ID | Type | Description | Link |
|---|---|---|---|
| Project DE 00562 | Other Identifier | Company internal | |
| 309761 | Other Identifier | Company internal |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875) | Experimental | Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec) |
|
| GD 0.1 mmol/kg BW (Magnevist, BAY86-4882) | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadobutrol (Gadavist, Gadovist, BAY86-4875) | Drug | 1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW) |
|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China | ||
| The 1st Affiliated Hosp of the 4th Military Med Uni |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
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Of 150 screened participants, 3 were not randomized (2 due to withdrawal of consent, and 1 due to poor physical condition). 147 participants were randomized to either Gadobutrol 0.1 mmol/kg body weight (BW) (72 participants) or Gadopentetate dimeglumine 0.1 mmol/kg BW (75 participants).
Participants were recruited at specialized study centers if they satisfied the inclusion and exclusion criteria. All had known or suspected central nervous system lesions (including cranial and spinal lesions) with an indication for contrast enhanced magnetic resonance imaging for diagnosis and further treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec) |
| FG001 | GD 0.1 mmol/kg BW (Magnevist, BAY86-4882) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Magnevist | Drug | 0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW) |
|
| 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) |
| Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
| 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 | 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. | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
| 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 | 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. | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
| 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 | 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. | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
| Xi'an |
| Shaanxi |
| 710032 |
| China |
| Chinese PLA General Hosp. | Beijing | 100853 | China |
| Fudan University Huashan Hospital | Shanghai | 200040 | China |
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
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec) |
| BG001 | GD 0.1 mmol/kg BW (Magnevist, BAY86-4882) | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Two participants in each treatment group had missing values for signal intensity for central nervous system lesions at pre- and post-contrast and could thus not be considered for evaluation. | Posted | Mean | Standard Deviation | Contrast to Noise ratio | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
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| Secondary | 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). | Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases | Posted | Mean | Standard Deviation | Lesions | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
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| Secondary | 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). | Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. | Posted | Number | Participants | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
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| Secondary | 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). | Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Lesion contrast enhancement of 1 participant in the Gadavist group was assessed by the investigator (but not the blinded readers) as 'not applicable'. | Posted | Mean | Standard Deviation | Contrast enhancement score | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
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| Secondary | 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). | Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Lesion contrast enhancement of 1 participant in the Gadavist group was assessed by the investigator (but not the blinded readers) as 'not applicable'. | Posted | Mean | Standard Deviation | Lesion delineation score | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
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| Other Pre-specified | 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 | 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. | Per Protocol Set (PPS): All valid case participants who received contrast injection. Subgroup: those with primary malignant brain tumor(s) / brain metastases. One participant in the Gadavist group had missing values for signal intensity for central nervous system lesions at pre- and post-contrast and could thus not be considered for evaluation. | Posted | Mean | Standard Deviation | Contrast to Noise ratio | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
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| Other Pre-specified | 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 | 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. | Per Protocol Set (PPS): All valid case participants who received contrast injection. Subgroup: those with CNS lesions other than primary malignant brain tumor(s) / brain metastases. 1 (Gadavist) and 2 participants (Magnevist) had missing values for signal intensity for CNS lesions pre- and post-contrast and could not be considered for evaluation. | Posted | Mean | Standard Deviation | Contrast to Noise ratio | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
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| Other Pre-specified | 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 | 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. | Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Subgroup: participants with primary malignant brain tumor(s) / brain metastases | Posted | Mean | Standard Deviation | Lesions | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
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| Other Pre-specified | 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 | 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. | Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Subgroup: participants with CNS lesions other than primary malignant brain tumor(s) / brain metastases | Posted | Mean | Standard Deviation | Lesions | Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec) | 0 | 71 | 2 | 71 | ||
| EG001 | GD 0.1 mmol/kg BW (Magnevist, BAY86-4882) | 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 | 0 | 75 | 4 | 75 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v. 10.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA v. 10.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA v. 10.0 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v. 10.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA v. 10.0 | Non-systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA v. 10.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v. 10.0 | Non-systematic Assessment |
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PIs shall provide sponsor with an advance copy of any proposed publication or oral presentation at least ninety (90) days prior to the date of the planned submission or presentation. Sponsor shall have sixty (60) days to recommend any changes it reasonably believes are necessary for scientific purposes or to preserve the confidentiality of sponsor's confidential information. PIs agree that the adoption of such recommended changes shall not be unreasonably refused.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C090600 | gadobutrol |
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
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| Male |
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| Units | Counts |
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| Participants |
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