Trial Outcomes & Findings for Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging (NCT NCT00709852)
NCT ID: NCT00709852
Last Updated: 2014-12-30
Results Overview
BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
COMPLETED
PHASE3
402 participants
Up to 2 hours after injection of gadobutrol
2014-12-30
Participant Flow
The date of the first participant's first visit was 11 JUN 2008. The date of the last participant's last visit was 03 APR 2009.
A total of 419 participants (part.) were screened; 17 prematurely discontinued prior to receiving any study drug. A total of 402 part. received study drug; 228 in gadobutrol : gadoteridol treatment sequence, 174 in gadoteridol : gadobutrol treatment sequence. Safety analysis set=402; gadobutrol=399, gadoteridol=393. Full analysis set (FAS)=336.
Participant milestones
| Measure |
Gadobutrol (Gadavist, BAY86-4875) : Gadoteridol (ProHance)
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2.
|
Gadoteridol (ProHance) : Gadobutrol (Gadavist, BAY86-4875)
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.
|
|---|---|---|
|
Period 1
STARTED
|
228
|
174
|
|
Period 1
COMPLETED
|
220
|
171
|
|
Period 1
NOT COMPLETED
|
8
|
3
|
|
Period 2
STARTED
|
220
|
171
|
|
Period 2
COMPLETED
|
211
|
169
|
|
Period 2
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
| Measure |
Gadobutrol (Gadavist, BAY86-4875) : Gadoteridol (ProHance)
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2.
|
Gadoteridol (ProHance) : Gadobutrol (Gadavist, BAY86-4875)
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.
|
|---|---|---|
|
Period 1
Adverse Event
|
2
|
0
|
|
Period 1
Withdrawal by Subject
|
4
|
2
|
|
Period 1
Protocol Violation
|
1
|
0
|
|
Period 1
Defective scanner
|
0
|
1
|
|
Period 1
Lost to Follow-up
|
1
|
0
|
|
Period 2
Protocol Violation
|
4
|
1
|
|
Period 2
Adverse Event
|
1
|
1
|
|
Period 2
Lost to Follow-up
|
1
|
0
|
|
Period 2
No 72-hour follow-up
|
3
|
0
|
Baseline Characteristics
Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=402 Participants
Includes participants who received either treatment
|
|---|---|
|
Age, Customized
< 45 years
|
144 participants
n=5 Participants
|
|
Age, Customized
45-64 years
|
164 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
94 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
227 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
175 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
235 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
31 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
112 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: The full analysis set (FAS); which used data from all participants for whom data and images were available for the unenhanced MRI, combined unenhanced and gadobutrol-enhanced MRI, and combined unenhanced and gadoteridol-enhanced MRI, excluding the sample participants (the first participant from each study site).
BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=314 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=314 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
contrast enhancement
|
0.94 scores on a scale
Standard Deviation 0.14
|
2.21 scores on a scale
Standard Deviation 0.57
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
border delineation
|
2.03 scores on a scale
Standard Deviation 0.37
|
2.70 scores on a scale
Standard Deviation 0.53
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
internal morphology
|
1.16 scores on a scale
Standard Deviation 0.26
|
1.78 scores on a scale
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=314 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=314 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
contrast enhancement
|
1.01 scores on a scale
Standard Deviation 0.28
|
2.60 scores on a scale
Standard Deviation 0.70
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
border delineation
|
2.19 scores on a scale
Standard Deviation 0.49
|
2.91 scores on a scale
Standard Deviation 0.60
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
internal morphology
|
1.46 scores on a scale
Standard Deviation 0.37
|
2.28 scores on a scale
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=312 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=312 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
contrast enhancement
|
0.96 scores on a scale
Standard Deviation 0.16
|
2.02 scores on a scale
Standard Deviation 0.46
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
border delineation
|
1.73 scores on a scale
Standard Deviation 0.32
|
2.16 scores on a scale
Standard Deviation 0.35
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
internal morphology
|
1.34 scores on a scale
Standard Deviation 0.32
|
1.76 scores on a scale
Standard Deviation 0.39
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=316 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=316 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)
contrast enhancement
|
0.97 scores on a scale
Standard Deviation 0.15
|
2.26 scores on a scale
Standard Deviation 0.52
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)
border delineation
|
1.98 scores on a scale
Standard Deviation 0.30
|
2.58 scores on a scale
Standard Deviation 0.43
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)
internal morphology
|
1.32 scores on a scale
Standard Deviation 0.24
|
1.93 scores on a scale
Standard Deviation 0.36
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers
BR1
|
7.41 lesions
Standard Deviation 13.05
|
7.80 lesions
Standard Deviation 12.92
|
|
Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers
BR2
|
10.07 lesions
Standard Deviation 16.60
|
9.63 lesions
Standard Deviation 15.04
|
|
Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers
BR3
|
6.75 lesions
Standard Deviation 8.97
|
7.31 lesions
Standard Deviation 9.13
|
|
Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers
AR
|
8.08 lesions
Standard Deviation 12.39
|
8.25 lesions
Standard Deviation 11.40
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=310 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=310 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
border delineation
|
2.14 scores on a scale
Standard Deviation 0.21
|
2.95 scores on a scale
Standard Deviation 0.31
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
contrast enhancement
|
1.00 scores on a scale
Standard Deviation 0.04
|
2.62 scores on a scale
Standard Deviation 0.30
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
internal morphology
|
1.26 scores on a scale
Standard Deviation 0.22
|
2.03 scores on a scale
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=310 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=310 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
border delineation
|
2.36 scores on a scale
Standard Deviation 0.33
|
3.22 scores on a scale
Standard Deviation 0.37
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
contrast enhancement
|
1.15 scores on a scale
Standard Deviation 0.45
|
3.28 scores on a scale
Standard Deviation 0.40
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
internal morphology
|
1.44 scores on a scale
Standard Deviation 0.31
|
2.54 scores on a scale
Standard Deviation 0.27
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=310 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=310 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
contrast enhancement
|
1.04 scores on a scale
Standard Deviation 0.14
|
2.39 scores on a scale
Standard Deviation 0.29
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
border delineation
|
1.75 scores on a scale
Standard Deviation 0.20
|
2.25 scores on a scale
Standard Deviation 0.28
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
internal morphology
|
1.42 scores on a scale
Standard Deviation 0.21
|
1.85 scores on a scale
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=310 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=310 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)
contrast enhancement
|
1.06 scores on a scale
Standard Deviation 0.16
|
2.76 scores on a scale
Standard Deviation 0.23
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)
border delineation
|
2.09 scores on a scale
Standard Deviation 0.17
|
2.81 scores on a scale
Standard Deviation 0.21
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)
internal morphology
|
1.38 scores on a scale
Standard Deviation 0.16
|
2.14 scores on a scale
Standard Deviation 0.18
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=267 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=267 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
border delineation
|
1.89 scores on a scale
Standard Deviation 0.74
|
2.40 scores on a scale
Standard Deviation 0.94
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
contrast enhancement
|
0.86 scores on a scale
Standard Deviation 0.30
|
1.69 scores on a scale
Standard Deviation 1.04
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
internal morphology
|
1.04 scores on a scale
Standard Deviation 0.47
|
1.48 scores on a scale
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=274 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=274 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
contrast enhancement
|
0.87 scores on a scale
Standard Deviation 0.31
|
1.75 scores on a scale
Standard Deviation 1.17
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
border delineation
|
1.97 scores on a scale
Standard Deviation 0.83
|
2.51 scores on a scale
Standard Deviation 1.06
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
internal morphology
|
1.47 scores on a scale
Standard Deviation 0.67
|
1.95 scores on a scale
Standard Deviation 0.83
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=277 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=277 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
border delineation
|
1.72 scores on a scale
Standard Deviation 0.63
|
2.05 scores on a scale
Standard Deviation 0.63
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
contrast enhancement
|
0.86 scores on a scale
Standard Deviation 0.30
|
1.55 scores on a scale
Standard Deviation 0.83
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
internal morphology
|
1.26 scores on a scale
Standard Deviation 0.60
|
1.64 scores on a scale
Standard Deviation 0.70
|
PRIMARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=293 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=293 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)
contrast enhancement
|
0.85 scores on a scale
Standard Deviation 0.26
|
1.62 scores on a scale
Standard Deviation 0.95
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)
border delineation
|
1.82 scores on a scale
Standard Deviation 0.62
|
2.26 scores on a scale
Standard Deviation 0.81
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)
internal morphology
|
1.23 scores on a scale
Standard Deviation 0.47
|
1.65 scores on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=315 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=315 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader
contrast enhancement
|
0.98 scores on a scale
Standard Deviation 0.14
|
2.22 scores on a scale
Standard Deviation 0.50
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader
border delineation
|
1.99 scores on a scale
Standard Deviation 0.28
|
2.55 scores on a scale
Standard Deviation 0.41
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader
internal morphology
|
1.32 scores on a scale
Standard Deviation 0.22
|
1.90 scores on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The AR analysis used the mean of the values for the 3 blinded readers
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader
|
8.08 lesions
Standard Deviation 12.39
|
8.24 lesions
Standard Deviation 11.79
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The AR analysis used the mean of the values for the 3 blinded readers.
Outcome measures
| Measure |
Unenhanced
n=315 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=315 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
contrast enhancement
|
2.28 scores on a scale
Standard Deviation 0.51
|
2.24 scores on a scale
Standard Deviation 0.49
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
border delineation
|
2.60 scores on a scale
Standard Deviation 0.39
|
2.56 scores on a scale
Standard Deviation 0.39
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
internal morphology
|
1.94 scores on a scale
Standard Deviation 0.34
|
1.91 scores on a scale
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The AR analysis used the mean of the values for the 3 blinded readers
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
|
8.25 lesions
Standard Deviation 11.40
|
8.24 lesions
Standard Deviation 11.79
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another and determined the number of lesion from each.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers
BR3
|
24.4 percentage of participants
|
40.2 percentage of participants
|
|
Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers
BR1
|
26.5 percentage of participants
|
34.8 percentage of participants
|
|
Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers
BR2
|
35.4 percentage of participants
|
34.5 percentage of participants
|
|
Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers
AR
|
35.1 percentage of participants
|
44.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average Reader
|
37.8 percentage of participants
|
41.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
|
41.7 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=329 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=329 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
border delineation
|
2.16 scores on a scale
Standard Deviation 0.62
|
2.90 scores on a scale
Standard Deviation 0.62
|
|
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
internal morphology
|
1.77 scores on a scale
Standard Deviation 0.55
|
2.38 scores on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
|
3.46 lesions
Standard Deviation 7.99
|
3.75 lesions
Standard Deviation 8.09
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=310 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=310 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
internal morphology
|
1.76 scores on a scale
Standard Deviation 0.48
|
2.40 scores on a scale
Standard Deviation 0.44
|
|
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
border delineation
|
2.13 scores on a scale
Standard Deviation 0.55
|
2.90 scores on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=272 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=272 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
border delineation
|
2.20 scores on a scale
Standard Deviation 0.95
|
2.94 scores on a scale
Standard Deviation 0.99
|
|
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
internal morphology
|
1.80 scores on a scale
Standard Deviation 0.80
|
2.36 scores on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=329 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=329 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
internal morphology
|
1.78 scores on a scale
Standard Deviation 0.55
|
2.36 scores on a scale
Standard Deviation 0.49
|
|
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
border delineation
|
2.17 scores on a scale
Standard Deviation 0.61
|
2.88 scores on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
|
3.46 lesions
Standard Deviation 7.99
|
3.74 lesions
Standard Deviation 8.15
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=310 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=310 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
border delineation
|
2.13 scores on a scale
Standard Deviation 0.55
|
2.91 scores on a scale
Standard Deviation 0.52
|
|
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
internal morphology
|
1.76 scores on a scale
Standard Deviation 0.48
|
2.39 scores on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=270 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=270 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
border delineation
|
2.23 scores on a scale
Standard Deviation 0.94
|
2.88 scores on a scale
Standard Deviation 0.97
|
|
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
internal morphology
|
1.83 scores on a scale
Standard Deviation 0.79
|
2.34 scores on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=328 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=328 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
border delineation
|
2.95 scores on a scale
Standard Deviation 0.55
|
2.91 scores on a scale
Standard Deviation 0.56
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
contrast enhancement
|
2.67 scores on a scale
Standard Deviation 0.70
|
2.60 scores on a scale
Standard Deviation 0.72
|
|
Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
internal morphology
|
2.42 scores on a scale
Standard Deviation 0.45
|
2.39 scores on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
|
3.75 lesions
Standard Deviation 8.09
|
3.74 lesions
Standard Deviation 8.15
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=310 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=310 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
contrast enhancement - gadobutrol combined
|
2.88 scores on a scale
Standard Deviation 0.52
|
2.85 scores on a scale
Standard Deviation 0.54
|
|
Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
border delineation - gadobutrol combined
|
2.90 scores on a scale
Standard Deviation 0.54
|
2.91 scores on a scale
Standard Deviation 0.52
|
|
Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
internal morphology - gadobutrol combined
|
2.40 scores on a scale
Standard Deviation 0.44
|
2.39 scores on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Outcome measures
| Measure |
Unenhanced
n=263 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=263 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
contrast enhancement
|
2.44 scores on a scale
Standard Deviation 1.21
|
2.34 scores on a scale
Standard Deviation 1.22
|
|
Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
border delineation
|
3.04 scores on a scale
Standard Deviation 0.88
|
2.94 scores on a scale
Standard Deviation 0.84
|
|
Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
internal morphology
|
2.44 scores on a scale
Standard Deviation 0.63
|
2.39 scores on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.
Outcome measures
| Measure |
Unenhanced
n=225 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=225 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
|
58.2 per. of the exact diagnostic matches
|
64.4 per. of the exact diagnostic matches
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.
Outcome measures
| Measure |
Unenhanced
n=292 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=292 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
|
69.2 per. of the exact diagnostic matches
|
79.1 per. of the exact diagnostic matches
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.
Outcome measures
| Measure |
Unenhanced
n=219 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=219 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
|
58.9 per. of the exact diagnostic matches
|
65.8 per. of the exact diagnostic matches
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.
Outcome measures
| Measure |
Unenhanced
n=292 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=292 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
|
69.2 per. of the exact diagnostic matches
|
78.4 per. of the exact diagnostic matches
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.
Outcome measures
| Measure |
Unenhanced
n=229 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=229 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader
|
65.1 per. of the exact diagnostic matches
|
65.5 per. of the exact diagnostic matches
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the clinical investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.
Outcome measures
| Measure |
Unenhanced
n=292 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=292 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
|
79.1 per. of the exact diagnostic matches
|
78.4 per. of the exact diagnostic matches
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.
Outcome measures
| Measure |
Unenhanced
n=267 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=267 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
|
66.7 percentage of participants
|
77.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=206 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=206 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
|
62.6 percentage of participants
|
76.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=61 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=61 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
|
80.3 percentage of participants
|
80.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.
Outcome measures
| Measure |
Unenhanced
n=267 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=267 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
|
66.7 percentage of participants
|
77.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=206 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=206 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
|
62.6 percentage of participants
|
75.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=61 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=61 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
|
80.3 percentage of participants
|
82.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.
Outcome measures
| Measure |
Unenhanced
n=267 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=267 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images
|
77.2 percentage of participants
|
77.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=206 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=206 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images
|
76.2 percentage of participants
|
75.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=61 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=61 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images
|
80.3 percentage of participants
|
82.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.
Outcome measures
| Measure |
Unenhanced
n=292 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=292 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
|
81.2 percentage of participants
|
87.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=93 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=93 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
|
47.3 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=199 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=199 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
|
97.0 percentage of participants
|
97.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.
Outcome measures
| Measure |
Unenhanced
n=292 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=292 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
|
87.3 percentage of participants
|
95.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=93 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=93 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
|
66.7 percentage of participants
|
88.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=199 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=199 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
|
97.0 percentage of participants
|
98.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.
Outcome measures
| Measure |
Unenhanced
n=292 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=292 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
|
81.2 percentage of participants
|
85.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee
Outcome measures
| Measure |
Unenhanced
n=93 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=93 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
|
47.3 percentage of participants
|
60.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=199 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=199 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
|
97.0 percentage of participants
|
97.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.
Outcome measures
| Measure |
Unenhanced
n=292 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=292 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
|
87.3 percentage of participants
|
94.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=93 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=93 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
|
66.7 percentage of participants
|
87.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=199 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=199 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
|
97.0 percentage of participants
|
98.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.
Outcome measures
| Measure |
Unenhanced
n=292 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=292 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader
|
87.7 percentage of participants
|
85.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=93 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=93 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader
|
66.7 percentage of participants
|
60.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=199 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=199 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader
|
97.5 percentage of participants
|
97.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.
Outcome measures
| Measure |
Unenhanced
n=292 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=292 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
|
95.2 percentage of participants
|
94.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=93 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=93 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
|
88.2 percentage of participants
|
87.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.
Outcome measures
| Measure |
Unenhanced
n=199 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=199 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
|
98.5 percentage of participants
|
98.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader
|
2.23 scores on a scale
Standard Deviation 0.48
|
2.80 scores on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader
|
2.23 scores on a scale
Standard Deviation 0.48
|
2.80 scores on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The BRs recorded his/her confidence in diagnosis for the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
|
2.80 scores on a scale
Standard Deviation 0.54
|
2.80 scores on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrolPopulation: All participants in the FAS with assessments for this outcome measure.
The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadobutrol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
|
2.59 scores on a scale
Standard Deviation 1.02
|
3.35 scores on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadoteridol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
|
2.59 scores on a scale
Standard Deviation 1.02
|
3.31 scores on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The investigator recorded his/her confidence in diagnosis for the combined unenhanced/gadobutrol-enhanced MR image sets and the combined unenhanced/gadoteridol MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
|
3.35 scores on a scale
Standard Deviation 0.76
|
3.31 scores on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
The BRs evaluated the relative image quality of the gadobutrol-enhanced T1w MR images and the gadoteridol-enhanced T1w MR images in a paired fashion on a 5-point scale where 1 = image on right was worse, 2 = image on right was slightly worse, 3 = both images were the same, 4 = image on right was slightly better, and 5 = image on right was better.
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Comparison of Image Quality Between Gadobutrol and Gadoteridol by Blinded Readers
blinded reader 4
|
0.33 scores on a scale
Standard Deviation 0.78
|
—
|
|
Comparison of Image Quality Between Gadobutrol and Gadoteridol by Blinded Readers
blinded reader 5
|
0.38 scores on a scale
Standard Deviation 0.83
|
—
|
|
Comparison of Image Quality Between Gadobutrol and Gadoteridol by Blinded Readers
blinded reader 6
|
0.53 scores on a scale
Standard Deviation 1.24
|
—
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
Percentage of participants for which blinded readers said image quality was higher
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Percentage of Participants for Which Blinded Readers Said Image Quality Was Higher
BR 4
|
36.0 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants for Which Blinded Readers Said Image Quality Was Higher
BR 5
|
35.1 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants for Which Blinded Readers Said Image Quality Was Higher
BR 6
|
62.2 percentage of participants
|
24.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
Two BRs independently provided the number of contrast-enhanced lesions for gadobutrol and gadoteridol. In cases of disagreement between the readers, an independent adjudicator provided the number of contrast-enhanced lesions. The adjudicator results were used in the analysis in the cases of disagreement between the original readers
Outcome measures
| Measure |
Unenhanced
n=336 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=336 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Assessment of the Number of Contrast-enhanced Lesions for Gadobutrol and Gadoteridol by Blinded Readers
|
1.73 lesions
Standard Deviation 4.74
|
1.73 lesions
Standard Deviation 4.89
|
SECONDARY outcome
Timeframe: Up to 2 hours after injection of gadobutrol or gadoteridolPopulation: All participants in the FAS with assessments for this outcome measure.
From the quantitative signal intensity values assessed by the BR, the percentage of lesion enhancement from unenhanced to combined unenhanced/enhanced was calculated.
Outcome measures
| Measure |
Unenhanced
n=185 Participants
Participants had diagnostic imaging before receiving any contrast agent
|
Combined Unenhanced/Gadobutrol-enhanced
n=185 Participants
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
|---|---|---|
|
Percentage of Lesion Enhancement From Unenhanced to Combined Unenhanced/Enhanced for Gadobutrol and Gadoteridol by Blinded Readers
|
80.1 percentage of lesion enhancement
Standard Deviation 58.4
|
77.7 percentage of lesion enhancement
Standard Deviation 52.3
|
Adverse Events
Gadobutrol (Gadavist, BAY86-4875)
Gadoteridol (ProHance)
Serious adverse events
| Measure |
Gadobutrol (Gadavist, BAY86-4875)
n=399 participants at risk
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
Gadoteridol (ProHance)
n=393 participants at risk
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
|
|---|---|---|
|
General disorders
General physical health deterioration
|
0.00%
0/399
|
0.25%
1/393 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.25%
1/399 • Number of events 1
|
0.00%
0/393
|
|
Nervous system disorders
Hydrocephalus
|
0.25%
1/399 • Number of events 1
|
0.00%
0/393
|
|
Nervous system disorders
Somnolence
|
0.00%
0/399
|
0.25%
1/393 • Number of events 1
|
Other adverse events
| Measure |
Gadobutrol (Gadavist, BAY86-4875)
n=399 participants at risk
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
|
Gadoteridol (ProHance)
n=393 participants at risk
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
7/399 • Number of events 7
|
1.3%
5/393 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
2.8%
11/399 • Number of events 11
|
4.3%
17/393 • Number of events 18
|
|
Gastrointestinal disorders
Vomiting
|
0.75%
3/399 • Number of events 3
|
1.0%
4/393 • Number of events 4
|
|
General disorders
Fatigue
|
1.0%
4/399 • Number of events 4
|
0.25%
1/393 • Number of events 1
|
|
Investigations
Blood glucose increased
|
1.0%
4/399 • Number of events 5
|
0.00%
0/393
|
|
Nervous system disorders
Dizziness
|
1.8%
7/399 • Number of events 8
|
1.3%
5/393 • Number of events 5
|
|
Nervous system disorders
Dysgeusia
|
1.3%
5/399 • Number of events 5
|
0.76%
3/393 • Number of events 3
|
|
Nervous system disorders
Headache
|
3.3%
13/399 • Number of events 13
|
2.5%
10/393 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.50%
2/399 • Number of events 2
|
1.3%
5/393 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor is interested in the publication of the results of every study it performs. All relevant aspects regarding publication will be part of the contract between the sponsor and the investigator/institution. The sponsor has committed to the global industry position on disclosure of information about clinical trials. The information regarding the study protocol is made publicly available on the internet at www.clinicaltrials.gov.
- Publication restrictions are in place
Restriction type: OTHER