Trial Outcomes & Findings for Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) (NCT NCT00862459)
NCT ID: NCT00862459
Last Updated: 2014-01-13
Results Overview
The primary visualization variables (number \[no.\] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)-(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
237 participants
Primary outcome timeframe
up to 2 hours after the injection of study medication
Results posted on
2014-01-13
Participant Flow
The date of the first participant's first visit was 27 August 2005. The date of the last participant's last visit was 26 March 2007.
242 participants were screened: 5 were screening failures (withdrew consent, did not meet study criteria, other). The remaining 237 were randomized to the 0.3, 0.1, or 0.03 millimole per kilogram (mmol/kg) group.
Participant milestones
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
Participant received one dose of 0.03 mmol/kg body weight (BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Overall Study
STARTED
|
72
|
93
|
72
|
|
Overall Study
Participants Received Treatment
|
70
|
90
|
69
|
|
Overall Study
COMPLETED
|
66
|
85
|
66
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
6
|
Reasons for withdrawal
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
Participant received one dose of 0.03 mmol/kg body weight (BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Personal reasons
|
1
|
0
|
0
|
|
Overall Study
Operation
|
1
|
1
|
0
|
|
Overall Study
Intravenous (IV) site problems
|
1
|
0
|
1
|
|
Overall Study
Unable to hold still for imaging
|
0
|
1
|
0
|
|
Overall Study
Inclusion/exclusion criteria not met
|
0
|
1
|
0
|
|
Overall Study
Administrative problems
|
0
|
1
|
0
|
Baseline Characteristics
Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Baseline characteristics by cohort
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=70 Participants
Participant received one dose of 0.03 millimole per kilogram of body weight (mmol/kg BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=90 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=69 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<45 years
|
36 Years
n=5 Participants
|
42 Years
n=7 Participants
|
29 Years
n=5 Participants
|
107 Years
n=4 Participants
|
|
Age, Customized
45-64 years
|
24 Years
n=5 Participants
|
39 Years
n=7 Participants
|
28 Years
n=5 Participants
|
91 Years
n=4 Participants
|
|
Age, Customized
>=65 years
|
10 Years
n=5 Participants
|
9 Years
n=7 Participants
|
12 Years
n=5 Participants
|
31 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
30 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: The per protocol set (PPS), which included all participants with valid images who received +/-10% of the intended dose of study drug and had no major protocol or Magnetic Resonance Imaging (MRI) procedure deviations (excluding one participant with insufficient images)
The primary visualization variables (number \[no.\] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)-(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Categorical Visualization Score (CVS)
|
1.43 Scores on a scale
Standard Deviation 1.07
|
2.02 Scores on a scale
Standard Deviation 1.04
|
1.98 Scores on a scale
Standard Deviation 1.20
|
PRIMARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding one participant with insufficient images)
Three blinded readers evaluated the unenhanced MRI sets and the combined unenhanced/gadobutrol-enhanced MRI sets to evaluate the number of lesions, which was then averaged to produce an average reader value.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI.
|
-0.03 Lesions per participant
Standard Deviation 1.82
|
0.04 Lesions per participant
Standard Deviation 2.28
|
0.09 Lesions per participant
Standard Deviation 2.22
|
PRIMARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects with no lesion detected)
The blinded readers assessed the degree of contrast enhancement for each lesion on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement, which was then averaged to produce an average reader score.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=58 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=53 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Assessment of Lesion Contrast Enhancement
|
0.98 scores on a scale
Standard Deviation 0.93
|
1.78 scores on a scale
Standard Deviation 1.07
|
1.79 scores on a scale
Standard Deviation 1.15
|
PRIMARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects with no lesion detected)
The blinded readers assessed the delineation for each lesion on a 4-point scale where 1 = none and 4 = excellent, which was then averaged to produce an average reader score.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=58 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=53 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Assessment of Border Delineation
|
0.28 scores on a scale
Standard Deviation 0.60
|
0.68 scores on a scale
Standard Deviation 0.61
|
0.70 scores on a scale
Standard Deviation 0.60
|
PRIMARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects with no lesion detected)
The blinded readers assessed the degree of information available about internal morphology and structure for each lesion on a 3-point scale where 1 = poor and 3 = good, which was then averaged to produce an average reader score.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=58 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=53 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Assessment of Internal Morphology
|
0.52 scores on a scale
Standard Deviation 0.50
|
0.90 scores on a scale
Standard Deviation 0.57
|
0.80 scores on a scale
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding participants with insufficient images)
CNR between white and gray matter in the perfusion imaging was defined as the signal intensity (SI) difference between white and gray matter divided by the standard deviation of the SI of white matter. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=60 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI
|
9.42 CNR
Standard Deviation 11.4
|
27.0 CNR
Standard Deviation 75.6
|
22.2 CNR
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects with no lesion detected)
The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for blinded reader (BR) 1.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=60 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 1
|
63.58 percentage of lesions
|
65.24 percentage of lesions
|
54.49 percentage of lesions
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects with no lesion detected)
The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 2
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=59 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=54 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 2
|
57.62 percentage of lesions
|
71.05 percentage of lesions
|
57.47 percentage of lesions
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects with no lesion detected)
The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 3
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=59 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 3
|
63.31 percentage of lesions
|
57.18 percentage of lesions
|
50.05 percentage of lesions
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects with no enhanced lesion detected)
The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 1
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=52 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=48 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=50 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 1
|
48.10 percentage of lesions
|
72.73 percentage of lesions
|
55.21 percentage of lesions
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects with no enhanced lesion detected)
The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 2
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=47 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=44 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=44 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 2
|
69.23 percentage of lesions
|
82.14 percentage of lesions
|
63.77 percentage of lesions
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS(excluding subjects with no enhanced lesion detected)
The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 3
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=51 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=46 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=48 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 3
|
55.07 percentage of lesions
|
73.53 percentage of lesions
|
68.24 percentage of lesions
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS
The gadobutrol-enhanced and unenhanced MRI diagnoses of the average reader were compared to the final diagnosis.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI
yes
|
62.3 percentage of exact matches
|
57.1 percentage of exact matches
|
54.2 percentage of exact matches
|
|
Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI
no
|
37.7 percentage of exact matches
|
42.9 percentage of exact matches
|
45.8 percentage of exact matches
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
The diagnostic confidence, the level of certainty in a diagnosis, was determined based on the average of the blinded readers.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI
somewhat confident
|
23.0 percentage of participants
|
28.6 percentage of participants
|
23.2 percentage of participants
|
|
Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI
not confident
|
3.3 percentage of participants
|
3.6 percentage of participants
|
3.6 percentage of participants
|
|
Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI
confident
|
49.2 percentage of participants
|
33.9 percentage of participants
|
39.3 percentage of participants
|
|
Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI
very confident
|
24.6 percentage of participants
|
33.9 percentage of participants
|
33.9 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 1 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1
Not Applicable (Appl.)
|
8.2 percentage of participants
|
7.1 percentage of participants
|
3.6 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1
missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1
not visible
|
16.4 percentage of participants
|
10.7 percentage of participants
|
21.4 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1
good
|
23 percentage of participants
|
19.6 percentage of participants
|
17.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1
excellent
|
13.1 percentage of participants
|
25 percentage of participants
|
32.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1
poor
|
21.3 percentage of participants
|
17.9 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1
moderate
|
16.4 percentage of participants
|
19.6 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of percentages may range from 99.9 to 100.1.
BR 2 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
good
|
19.7 percentage of participants
|
23.2 percentage of participants
|
26.8 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
Not Appl.
|
9.8 percentage of participants
|
10.7 percentage of participants
|
10.7 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
not visible
|
8.2 percentage of participants
|
12.5 percentage of participants
|
8.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
poor
|
27.9 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
moderate
|
24.6 percentage of participants
|
21.4 percentage of participants
|
16.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
excellent
|
8.2 percentage of participants
|
19.6 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 3 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
Not Appl.
|
11.5 percentage of participants
|
8.9 percentage of participants
|
16.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
not visible
|
13.1 percentage of participants
|
23.2 percentage of participants
|
19.6 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
poor
|
23 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
moderate
|
26.2 percentage of participants
|
23.2 percentage of participants
|
16.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
good
|
16.4 percentage of participants
|
12.5 percentage of participants
|
10.7 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
excellent
|
8.2 percentage of participants
|
19.6 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 1 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1
good
|
19.7 percentage of participants
|
21.4 percentage of participants
|
30.4 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1
Not Appl.
|
8.2 percentage of participants
|
10.7 percentage of participants
|
3.6 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1
missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1
not visible
|
6.6 percentage of participants
|
14.3 percentage of participants
|
25 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1
poor
|
24.6 percentage of participants
|
19.6 percentage of participants
|
10.7 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1
moderate
|
21.3 percentage of participants
|
8.9 percentage of participants
|
8.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1
excellent
|
18 percentage of participants
|
25 percentage of participants
|
21.4 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 2 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
Not Appl.
|
11.5 percentage of participants
|
16.1 percentage of participants
|
7.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
not visible
|
6.6 percentage of participants
|
5.4 percentage of participants
|
14.3 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
poor
|
21.3 percentage of participants
|
14.3 percentage of participants
|
7.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
moderate
|
23 percentage of participants
|
21.4 percentage of participants
|
14.3 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
good
|
26.2 percentage of participants
|
17.9 percentage of participants
|
32.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
excellent
|
9.8 percentage of participants
|
25 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 3 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
Not Appl.
|
11.5 percentage of participants
|
12.5 percentage of participants
|
17.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
missing
|
1.6 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
good
|
21.3 percentage of participants
|
16.1 percentage of participants
|
23.2 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
excellent
|
6.6 percentage of participants
|
19.6 percentage of participants
|
14.3 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
not visible
|
14.8 percentage of participants
|
19.6 percentage of participants
|
23.2 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
poor
|
24.6 percentage of participants
|
12.5 percentage of participants
|
10.7 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
moderate
|
19.7 percentage of participants
|
17.9 percentage of participants
|
10.7 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 1 evaluated the visibility of the lesion(s) on the CBF perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1
moderate
|
14.8 percentage of participants
|
17.9 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1
Not Appl.
|
6.6 percentage of participants
|
12.5 percentage of participants
|
1.8 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1
missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1
not visible
|
13.1 percentage of participants
|
14.3 percentage of participants
|
23.2 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1
poor
|
31.1 percentage of participants
|
7.1 percentage of participants
|
14.3 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1
good
|
9.8 percentage of participants
|
17.9 percentage of participants
|
30.4 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1
excellent
|
23 percentage of participants
|
30.4 percentage of participants
|
17.9 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 2 evaluated the visibility of the lesion(s) on the CBF perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2
not visible
|
11.5 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2
poor
|
21.3 percentage of participants
|
8.9 percentage of participants
|
19.6 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2
moderate
|
23 percentage of participants
|
25 percentage of participants
|
25 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2
Not Appl.
|
8.2 percentage of participants
|
12.5 percentage of participants
|
8.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2
missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2
good
|
24.6 percentage of participants
|
16.1 percentage of participants
|
8.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2
excellent
|
9.8 percentage of participants
|
25 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 3 evaluated the visibility of the lesion(s) on the CBF perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3
Not Appl.
|
13.1 percentage of participants
|
10.7 percentage of participants
|
16.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3
missing
|
1.6 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3
not visible
|
14.8 percentage of participants
|
17.9 percentage of participants
|
25 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3
poor
|
14.8 percentage of participants
|
21.4 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3
excellent
|
6.6 percentage of participants
|
17.9 percentage of participants
|
17.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3
moderate
|
31.1 percentage of participants
|
10.7 percentage of participants
|
10.7 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3
good
|
18 percentage of participants
|
19.6 percentage of participants
|
17.9 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 1 evaluated the visibility of the lesion(s) on the TTP perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1
not visible
|
34.4 percentage of participants
|
21.4 percentage of participants
|
26.8 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1
poor
|
29.5 percentage of participants
|
14.3 percentage of participants
|
21.4 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1
Not Appl.
|
6.6 percentage of participants
|
8.9 percentage of participants
|
5.4 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1
missing
|
1.6 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1
moderate
|
9.8 percentage of participants
|
10.7 percentage of participants
|
10.7 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1
good
|
13.1 percentage of participants
|
17.9 percentage of participants
|
14.3 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1
excellent
|
4.9 percentage of participants
|
25 percentage of participants
|
21.4 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 2 evaluated the visibility of the lesion(s) on the TTP perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2
not visible
|
18 percentage of participants
|
5.4 percentage of participants
|
14.3 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2
moderate
|
11.5 percentage of participants
|
33.9 percentage of participants
|
23.2 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2
good
|
13.1 percentage of participants
|
17.9 percentage of participants
|
17.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2
Not Appl.
|
24.6 percentage of participants
|
17.9 percentage of participants
|
8.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2
missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2
poor
|
26.2 percentage of participants
|
21.4 percentage of participants
|
30.4 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2
excellent
|
4.9 percentage of participants
|
3.6 percentage of participants
|
5.4 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS
BR 3 evaluated the visibility of the lesion(s) on the TTP perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3
Not Appl.
|
11.5 percentage of participants
|
10.7 percentage of participants
|
17.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3
missing
|
1.6 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3
not visible
|
32.8 percentage of participants
|
25 percentage of participants
|
21.4 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3
moderate
|
18 percentage of participants
|
19.6 percentage of participants
|
25 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3
good
|
9.8 percentage of participants
|
16.1 percentage of participants
|
10.7 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3
poor
|
23 percentage of participants
|
23.2 percentage of participants
|
16.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3
excellent
|
3.3 percentage of participants
|
3.6 percentage of participants
|
8.9 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS
BR 1 evaluated the visibility of the lesion(s) on the MTT perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1
good
|
19.7 percentage of participants
|
26.8 percentage of participants
|
25 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1
Not Appl.
|
8.2 percentage of participants
|
7.1 percentage of participants
|
3.6 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1
missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1
not visible
|
16.4 percentage of participants
|
16.1 percentage of participants
|
19.6 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1
poor
|
19.7 percentage of participants
|
19.6 percentage of participants
|
19.6 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1
moderate
|
26.2 percentage of participants
|
12.5 percentage of participants
|
14.3 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1
excellent
|
8.2 percentage of participants
|
17.9 percentage of participants
|
17.9 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 2 evaluated the visibility of the lesion(s) on the MTT perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2
Not Appl.
|
13.1 percentage of participants
|
16.1 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2
missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2
not visible
|
14.8 percentage of participants
|
14.3 percentage of participants
|
14.3 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2
poor
|
37.7 percentage of participants
|
30.4 percentage of participants
|
23.2 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2
moderate
|
16.4 percentage of participants
|
16.1 percentage of participants
|
17.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2
good
|
13.1 percentage of participants
|
12.5 percentage of participants
|
19.6 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2
excellent
|
3.3 percentage of participants
|
10.7 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 3 evaluated the visibility of the lesion(s) on the MTT perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3
moderate
|
29.5 percentage of participants
|
30.4 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3
Not Appl.
|
11.5 percentage of participants
|
12.5 percentage of participants
|
16.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3
missing
|
1.6 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3
not visible
|
19.7 percentage of participants
|
25 percentage of participants
|
21.4 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3
poor
|
19.7 percentage of participants
|
12.5 percentage of participants
|
16.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3
good
|
13.1 percentage of participants
|
7.1 percentage of participants
|
17.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3
excellent
|
4.9 percentage of participants
|
10.7 percentage of participants
|
16.1 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 1 evaluated the visibility of the lesion(s) on the PF perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1
Not Appl.
|
13.1 percentage of participants
|
8.9 percentage of participants
|
1.8 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1
not visible
|
11.5 percentage of participants
|
21.4 percentage of participants
|
28.6 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1
poor
|
21.3 percentage of participants
|
23.2 percentage of participants
|
19.6 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1
moderate
|
13.1 percentage of participants
|
7.1 percentage of participants
|
17.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1
good
|
19.7 percentage of participants
|
21.4 percentage of participants
|
17.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1
excellent
|
21.3 percentage of participants
|
17.9 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
BR 2 evaluated the visibility of the lesion(s) on the PF perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2
poor
|
21.3 percentage of participants
|
17.9 percentage of participants
|
16.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2
good
|
19.7 percentage of participants
|
16.1 percentage of participants
|
26.8 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2
Not Appl.
|
14.8 percentage of participants
|
16.1 percentage of participants
|
8.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2
missing
|
3.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2
not visible
|
6.6 percentage of participants
|
14.3 percentage of participants
|
16.1 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2
moderate
|
26.2 percentage of participants
|
28.6 percentage of participants
|
25 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2
excellent
|
8.2 percentage of participants
|
7.1 percentage of participants
|
7.1 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS
BR 3 evaluated the visibility of the lesion(s) on the PF perfusion map.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3
Not Appl.
|
11.5 percentage of participants
|
10.7 percentage of participants
|
19.6 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3
missing
|
4.9 percentage of participants
|
3.6 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3
not visible
|
13.1 percentage of participants
|
26.8 percentage of participants
|
25 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3
poor
|
24.6 percentage of participants
|
14.3 percentage of participants
|
14.3 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3
moderate
|
21.3 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3
good
|
18 percentage of participants
|
21.4 percentage of participants
|
17.9 percentage of participants
|
|
Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3
excellent
|
6.6 percentage of participants
|
10.7 percentage of participants
|
10.7 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects whose parameter map value was not determined)
The independent radiologist determined the uncorrected CBV for each lesion. CBV is the volume of blood in the tissue.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=45 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=42 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) - Independent Radiologist
|
114.61 mL / 100 g tissue
Standard Deviation 127.75
|
346.81 mL / 100 g tissue
Standard Deviation 313.49
|
1209.89 mL / 100 g tissue
Standard Deviation 1121.63
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects whose parameter map value was not determined)
The independent radiologist determined the corrected CBV for each lesion. CBV is the volume of blood in the tissue.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=44 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=42 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) - Independent Radiologist
|
2728.71 mL / 100 g tissue
Standard Deviation 2788.59
|
2682.97 mL / 100 g tissue
Standard Deviation 1493.95
|
3382.20 mL / 100 g tissue
Standard Deviation 1908.56
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects whose parameter map value was not determined)
The independent radiologist determined the CBF for each lesion. CBF is the volume of blood passing through tissue per unit of time.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=44 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=42 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) - Independent Radiologist
|
4.80 mL / 100 g tissue / min.
Standard Deviation 6.37
|
5.15 mL / 100 g tissue / min.
Standard Deviation 4.30
|
3.48 mL / 100 g tissue / min.
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects whose parameter map value was not determined)
The independent radiologist determined the TTP for each lesion. TTP is the delay between the arrival of the contrast agent bolus arrival time and the peak of the concentration curve.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=45 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=42 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) - Independent Radiologist
|
79.39 seconds
Standard Deviation 25.43
|
80.31 seconds
Standard Deviation 27.21
|
86.52 seconds
Standard Deviation 28.70
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects whose parameter map value was not determined)
The independent radiologist determined the MTT for each lesion. The MTT is the time (seconds) for contrast to pass through tissues.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=44 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=42 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) - Independent Radiologist
|
6.30 seconds
Standard Deviation 4.77
|
6.02 seconds
Standard Deviation 3.71
|
7.05 seconds
Standard Deviation 4.54
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects whose parameter map value was not determined)
The independent radiologist determined the PF for each lesion
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=54 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=44 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=42 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) - Independent Radiologist
|
4.04 seconds
Standard Deviation 3.35
|
1.65 seconds
Standard Deviation 0.82
|
0.99 seconds
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS
The blinded reader evaluated if artifacts were present on the uncorrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 1 - Missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 1 - 0 none
|
72.1 percentage of participants
|
75 percentage of participants
|
69.6 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 1 - EPI distortion
|
24.6 percentage of participants
|
23.2 percentage of participants
|
21.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 1 - movement artifacts
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 2 - movement artifacts
|
32.8 percentage of participants
|
23.2 percentage of participants
|
3.6 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 3 - Missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 3 - EPI distortion
|
6.6 percentage of participants
|
16.1 percentage of participants
|
10.7 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 3 - other
|
11.5 percentage of participants
|
1.8 percentage of participants
|
3.6 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 1 - other
|
1.6 percentage of participants
|
1.8 percentage of participants
|
7.1 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded reader 2 - Missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 2 - 0 none
|
62.3 percentage of participants
|
66.1 percentage of participants
|
89.3 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 2 - EPI distortion
|
3.3 percentage of participants
|
10.7 percentage of participants
|
5.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 2 - other
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 3 - none
|
62.3 percentage of participants
|
67.9 percentage of participants
|
78.6 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 3 - T2 artifacts
|
3.3 percentage of participants
|
10.7 percentage of participants
|
3.6 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 3 - movement artifacts
|
14.8 percentage of participants
|
3.6 percentage of participants
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS
The blinded reader evaluated if artifacts were present on the corrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time. CBV is the fraction of the tissue volume occupied by the blood.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 3 - EPI distortion
|
4.9 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 3 - T2 artifacts
|
6.6 percentage of participants
|
10.7 percentage of participants
|
3.6 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 1 - Missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 1 - 0 none
|
75.4 percentage of participants
|
76.8 percentage of participants
|
66.1 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 1 - EPI distortion
|
21.3 percentage of participants
|
23.2 percentage of participants
|
28.6 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 1 - other
|
1.6 percentage of participants
|
0 percentage of participants
|
5.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 2 - Missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 2 - 0 none
|
78.7 percentage of participants
|
80.4 percentage of participants
|
83.9 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 2 - EPI distortion
|
6.6 percentage of participants
|
8.9 percentage of participants
|
14.3 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 2 - movement artifacts
|
13.1 percentage of participants
|
10.7 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 2 - other
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 3 - Missing
|
1.6 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 3 - 0 none
|
55.7 percentage of participants
|
69.6 percentage of participants
|
76.8 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 3 - movement artifacts
|
23 percentage of participants
|
1.8 percentage of participants
|
1.8 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Blinded Reader 3 - other
|
8.2 percentage of participants
|
3.6 percentage of participants
|
5.4 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS
The blinded reader evaluated if artifacts were present on the CBF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 1 - Missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 3 - 0 none
|
68.9 percentage of participants
|
76.8 percentage of participants
|
75 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 3 - other
|
8.2 percentage of participants
|
0 percentage of participants
|
3.6 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 1 - 0 none
|
70.5 percentage of participants
|
85.7 percentage of participants
|
71.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 1 - EPI distortion
|
26.2 percentage of participants
|
12.5 percentage of participants
|
23.2 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 1 - T2 artifacts
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 1 - other
|
0 percentage of participants
|
1.8 percentage of participants
|
5.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 2- Missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 2- 0 none
|
77 percentage of participants
|
82.1 percentage of participants
|
80.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 2 - EPI distortion
|
6.6 percentage of participants
|
7.1 percentage of participants
|
10.7 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 2- movement artifacts
|
14.8 percentage of participants
|
10.7 percentage of participants
|
7.1 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 2- other
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 3 - Missing
|
1.6 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 3 - EPI distortion
|
6.6 percentage of participants
|
10.7 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 3 - T2 artifacts
|
11.5 percentage of participants
|
8.9 percentage of participants
|
8.9 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Blinded Reader 3 - movement artifacts
|
3.3 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS
The blinded reader evaluated if artifacts were present on the TTP perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 2 - other
|
19.7 percentage of participants
|
8.9 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 1 - missing
|
1.6 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 1 - 0 none
|
75.4 percentage of participants
|
76.8 percentage of participants
|
75 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 1 - EPI distortion
|
14.8 percentage of participants
|
21.4 percentage of participants
|
19.6 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 1- movement artifacts
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 1 - other
|
6.6 percentage of participants
|
0 percentage of participants
|
5.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 2 - missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 2 - 0 none
|
34.4 percentage of participants
|
62.5 percentage of participants
|
71.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 2 - EPI distortion
|
6.6 percentage of participants
|
8.9 percentage of participants
|
10.7 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 2 - movement artifacts
|
37.7 percentage of participants
|
19.6 percentage of participants
|
17.9 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 3 - missing
|
1.6 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 3 - 0 none
|
41 percentage of participants
|
57.1 percentage of participants
|
64.3 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 3 - EPI distortions
|
4.9 percentage of participants
|
10.7 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 3 - T2 artifacts
|
3.3 percentage of participants
|
8.9 percentage of participants
|
8.9 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader3 - movement artifacts
|
26.2 percentage of participants
|
5.4 percentage of participants
|
7.1 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Blinded Reader 3 - other
|
23 percentage of participants
|
16.1 percentage of participants
|
7.1 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS
The blinded reader evaluated if artifacts were present on the MTT perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 1 - missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 1 - movement artifacts
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 1 - 0 none
|
80.3 percentage of participants
|
67.9 percentage of participants
|
71.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 1 - EPI distortion
|
16.4 percentage of participants
|
30.4 percentage of participants
|
19.6 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 1 - T2 artifacts
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 1 - other
|
1.6 percentage of participants
|
1.8 percentage of participants
|
5.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 2 - missing
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 2 - none
|
41 percentage of participants
|
71.4 percentage of participants
|
73.2 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 2 - EPI distortion
|
1.6 percentage of participants
|
5.4 percentage of participants
|
8.9 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 2 - movement artifacts
|
52.5 percentage of participants
|
23.2 percentage of participants
|
16.1 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 2 - other
|
3.3 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 3 - missing
|
1.6 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 3 - 0 none
|
50.8 percentage of participants
|
66.1 percentage of participants
|
69.6 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 3 - EPI distortion
|
8.2 percentage of participants
|
7.1 percentage of participants
|
16.1 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 3 - T2 artifacts
|
3.3 percentage of participants
|
5.4 percentage of participants
|
5.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 3 - movement artifacts
|
26.2 percentage of participants
|
10.7 percentage of participants
|
5.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Blinded Reader 3 - other
|
9.8 percentage of participants
|
8.9 percentage of participants
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS
The blinded reader evaluated if artifacts were present on the PF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 2 - EPI distortion
|
4.9 percentage of participants
|
8.9 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 1 - 0 none
|
73.8 percentage of participants
|
75 percentage of participants
|
71.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 1 - EPI distortion
|
21.3 percentage of participants
|
23.2 percentage of participants
|
26.8 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 1 - T2 artifacts
|
0 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 1 - movement artifacts
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 1 - other
|
3.3 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 2 - missing
|
3.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 2 - 0 none
|
73.8 percentage of participants
|
75 percentage of participants
|
73.2 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 2 - movement artifacts
|
16.4 percentage of participants
|
16.1 percentage of participants
|
14.3 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 2 - other
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 3 - missing
|
4.9 percentage of participants
|
3.6 percentage of participants
|
0 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 3 - 0 none
|
37.7 percentage of participants
|
51.8 percentage of participants
|
69.6 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 3 - EPI distortion
|
8.2 percentage of participants
|
10.7 percentage of participants
|
12.5 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 3 - T2 artifacts
|
4.9 percentage of participants
|
10.7 percentage of participants
|
5.4 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 3 - movement artifacts
|
36.1 percentage of participants
|
14.3 percentage of participants
|
7.1 percentage of participants
|
|
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Blinded Reader 3 - other
|
8.2 percentage of participants
|
8.9 percentage of participants
|
5.4 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS participants with tumors
The blinded readers gave an estimation of the tumor grade of brain tumors (low grade \[I or II\] or high grade \[III or IV\]) in terms of malignancy using the information obtained by perfusion imaging, which was compared to the biopsy sample results
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=61 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=55 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=56 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group
Blinded Reader 1
|
60.0 Percentage of accuracy
|
57.1 Percentage of accuracy
|
40.0 Percentage of accuracy
|
|
Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group
Blinded Reader 2
|
40.0 Percentage of accuracy
|
42.9 Percentage of accuracy
|
40.0 Percentage of accuracy
|
|
Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group
Blinded Reader 3
|
60.0 Percentage of accuracy
|
57.1 Percentage of accuracy
|
30.0 Percentage of accuracy
|
SECONDARY outcome
Timeframe: up to 2 hours after the injection of study medicationPopulation: PPS (excluding subjects who had no lesion detected, and those who had no value determined)
CNR between lesion/gray matter and lesion/white matter in the perfusion imaging was defined as the signal intensity (SI) difference between lesion and gray or white matter divided by the standard deviation of background noise. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.
Outcome measures
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=48 Participants
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=44 Participants
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=39 Participants
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|
|
Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter
lesion white
|
-10 CNR
Standard Deviation 12
|
-17 CNR
Standard Deviation 19.9
|
-17 CNR
Standard Deviation 20.4
|
|
Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter
lesion gray
|
-0.03 CNR
Standard Deviation 13.0
|
13.0 CNR
Standard Deviation 78.4
|
5.38 CNR
Standard Deviation 25.0
|
Adverse Events
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Optimark~0.1mmol/kg BW
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=67 participants at risk
Reporting Group 1 (RG1): Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=90 participants at risk
Reporting group 2 (RG2): Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=68 participants at risk
Reporting group 3 (RG3): Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Optimark~0.1mmol/kg BW
n=227 participants at risk
Reporting group 4 (RG4): Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|---|
|
Nervous system disorders
Brain oedema
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/67
|
0.00%
0/90
|
0.00%
0/68
|
0.44%
1/227
|
Other adverse events
| Measure |
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)
n=67 participants at risk
Reporting Group 1 (RG1): Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
n=90 participants at risk
Reporting group 2 (RG2): Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
n=68 participants at risk
Reporting group 3 (RG3): Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
Optimark~0.1mmol/kg BW
n=227 participants at risk
Reporting group 4 (RG4): Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
|
|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/67
|
1.1%
1/90
|
2.9%
2/68
|
0.88%
2/227
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Gastrointestinal disorders
Faeces discoloured
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/67
|
3.3%
3/90
|
1.5%
1/68
|
1.3%
3/227
|
|
Gastrointestinal disorders
Stomach discomfort
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/67
|
1.1%
1/90
|
1.5%
1/68
|
0.00%
0/227
|
|
General disorders
Application site erythema
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
General disorders
Asthenia
|
1.5%
1/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
General disorders
Chest pain
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
General disorders
Chills
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
General disorders
Feeling hot
|
0.00%
0/67
|
0.00%
0/90
|
2.9%
2/68
|
0.00%
0/227
|
|
General disorders
Influenza like illness
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
General disorders
Injection site erythema
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.88%
2/227
|
|
General disorders
Injection site irritation
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
General disorders
Injection site pain
|
0.00%
0/67
|
2.2%
2/90
|
0.00%
0/68
|
0.00%
0/227
|
|
General disorders
Malaise
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
General disorders
Oedema peripheral
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.44%
1/227
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/67
|
0.00%
0/90
|
1.5%
1/68
|
0.44%
1/227
|
|
Injury, poisoning and procedural complications
Contusion
|
3.0%
2/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Investigations
Blood sodium decreased
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Investigations
Electrocardiogram ST segment depression
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Investigations
Heart rate increased
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Investigations
Protein urine present
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.44%
1/227
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Nervous system disorders
Burning sensation
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Nervous system disorders
Convulsion
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Nervous system disorders
Dizziness
|
3.0%
2/67
|
2.2%
2/90
|
1.5%
1/68
|
1.8%
4/227
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/67
|
2.2%
2/90
|
0.00%
0/68
|
0.44%
1/227
|
|
Nervous system disorders
Headache
|
11.9%
8/67
|
7.8%
7/90
|
4.4%
3/68
|
3.5%
8/227
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/67
|
0.00%
0/90
|
2.9%
2/68
|
0.88%
2/227
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Nervous system disorders
Somnolence
|
1.5%
1/67
|
1.1%
1/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Psychiatric disorders
Claustrophobia
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.44%
1/227
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Renal and urinary disorders
Bladder discomfort
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Renal and urinary disorders
Dysuria
|
3.0%
2/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Reproductive system and breast disorders
Galactorrhoea
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/67
|
1.1%
1/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/67
|
1.1%
1/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.5%
1/67
|
1.1%
1/90
|
0.00%
0/68
|
0.44%
1/227
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.88%
2/227
|
|
Vascular disorders
Hot flush
|
0.00%
0/67
|
0.00%
0/90
|
1.5%
1/68
|
0.00%
0/227
|
|
Vascular disorders
Hyperaemia
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Vascular disorders
Hypertension
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Vascular disorders
Hypotension
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Vascular disorders
Orthostatic hypotension
|
1.5%
1/67
|
0.00%
0/90
|
0.00%
0/68
|
0.00%
0/227
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/67
|
1.1%
1/90
|
0.00%
0/68
|
0.00%
0/227
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of results will be a group publication. Sites with recruitment of \>= 6 valid patients will contribute. There will be one author from each site having contributed \>= 6 valid patients. Authorship listed according to recruitment. Sponsor will appoint up to 3 persons as co-authors. Main author of publication may be announced by site with most valid patients enrolled. In case more than 1 center reaches maximum patient No., main author will be from the center with fastest recruitment
- Publication restrictions are in place
Restriction type: OTHER