Brain Metastases
Conditions
Keywords
MRI, Brain Metastasis, Gadolinium, Imaging, Diagnostic Agent
Brief summary
This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.
Interventions
Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw)
DRUGProHance
ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Japanese patients at least 20 years of age * Patients with diagnosed primary cancer * Patients with metastatic lesions by CT/MRI
Exclusion criteria
* Patients who have contraindication to the MRI examinations * Patients who have severe renal disorder * Patients in extremely serious general condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions Detected by Blinded Readers (BR) and Investigator | one day | Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator | one day | Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=No, 2=Moderate, 3=Good, 4=Excellent) |
| Score of Visibility Assessment - Border Delineation by Blinded Reader | one day | Border delineation for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=None, 2=Moderate, 3=Good, 4=Excellent) |
| Score of Visibility Assessment - Border Delineation by Investigator | one day | Border delineation for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=None, 2=Moderate, 3=Good, 4=Excellent) |
| Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE) | one day | Treatment planning confidence evaluated separately for each image set (gadobutrol \[Gado-\] 0.1 mmol/kg bw and gadoteridol \[Pro-\] 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable) |
| Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | one day | Treatment planning confidence evaluated separately for each image set (gadobutrol 0.1 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable) |
| Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE | one day | Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable) |
| Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | one day | Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable) |
| Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader | one day | Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=No, 2=Moderate, 3=Good, 4=Excellent) |
| Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator | one day | Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator |
| Number of Participants With Reasons for Performance in SRS Planning by TPE | one day | Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable) |
| Number of Participants With Reasons for Performance in SRS Planning by Investigator | one day | Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable) |
| Lesion Size Evaluated by Independent Radiologist | one day | Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions) |
| Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist | one day | CNR of lesion/normal white matter based on the signal intensity of MR images evaluated by independent radiologist (mean and standard deviation of 306 lesions) |
| Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions | one day | ICC among 3 blinded readers calculated for number of detected lesions using the statistical model with two random effects, i.e., blinded readers and individual patients. |
| Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE | one day | Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE |
Countries
Japan
Participant flow
Pre-assignment details
A total of 175 participants were enrolled into the study. 10 were withdrawn from the study before entering Study Period 1. Safety Analysis Set included 164 participants; gadobutrol=161, ProHance=162. Per Protocol Set (PPS) included 151 participants.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population includes all participants received treatment | 164 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | body motion | 0 | 1 |
| Period 2 | residual contrast medium | 1 | 1 |
| Period 2 | Withdrawal by Subject | 1 | 0 |
| Washout Period | Adverse Event | 0 | 1 |
| Washout Period | Death | 0 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 11.8 |
| Body weight | 56.7 kg STANDARD_DEVIATION 12.2 |
| Height | 160.9 cm STANDARD_DEVIATION 8.7 |
| Primary focus Breast cancer | 20 participants |
| Primary focus Lung cancer | 123 participants |
| Primary focus Others | 21 participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 161 | 9 / 162 |
| serious Total, serious adverse events | 0 / 161 | 2 / 162 |
Outcome results
Primary
Number of Lesions Detected by Blinded Readers (BR) and Investigator
Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Number of Lesions Detected by Blinded Readers (BR) and Investigator | averaged blinded reader | 6.28 lesions | Standard Deviation 8.31 |
| Gadobutrol 0.1 mmol/kg bw | Number of Lesions Detected by Blinded Readers (BR) and Investigator | investigator | 6.36 lesions | Standard Deviation 8.26 |
| Gadobutrol 0.2 mmol/kg bw | Number of Lesions Detected by Blinded Readers (BR) and Investigator | averaged blinded reader | 6.92 lesions | Standard Deviation 8.69 |
| Gadobutrol 0.2 mmol/kg bw | Number of Lesions Detected by Blinded Readers (BR) and Investigator | investigator | 6.87 lesions | Standard Deviation 8.49 |
| Gadoteridol (ProHance) 0.2mmol/kg bw | Number of Lesions Detected by Blinded Readers (BR) and Investigator | averaged blinded reader | 6.87 lesions | Standard Deviation 8.65 |
| Gadoteridol (ProHance) 0.2mmol/kg bw | Number of Lesions Detected by Blinded Readers (BR) and Investigator | investigator | 6.66 lesions | Standard Deviation 8.41 |
Comparison: H01: μG1 - μPr ≤ -195% CI: [-0.87, -0.29]
Comparison: H02: μG2 - μPr ≤ -195% CI: [-0.23, 0.36]
Comparison: H01: μG1 - μPr ≤ -195% CI: [-0.5, -0.1]
Comparison: H02: μG2 - μPr ≤ -195% CI: [0.02, 0.41]
Secondary
Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist
CNR of lesion/normal white matter based on the signal intensity of MR images evaluated by independent radiologist (mean and standard deviation of 306 lesions)
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist | 36.74 CNR | Standard Deviation 47.82 |
| Gadobutrol 0.2 mmol/kg bw | Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist | 60.09 CNR | Standard Deviation 67.4 |
| Gadoteridol (ProHance) 0.2mmol/kg bw | Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist | 53.01 CNR | Standard Deviation 56.2 |
Secondary
Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions
ICC among 3 blinded readers calculated for number of detected lesions using the statistical model with two random effects, i.e., blinded readers and individual patients.
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions | 0.963 ICC |
| Gadobutrol 0.2 mmol/kg bw | Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions | 0.955 ICC |
| Gadoteridol (ProHance) 0.2mmol/kg bw | Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions | 0.949 ICC |
Secondary
Lesion Size Evaluated by Independent Radiologist
Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Lesion Size Evaluated by Independent Radiologist | 8.79 mm | Standard Deviation 8.06 |
| Gadobutrol 0.2 mmol/kg bw | Lesion Size Evaluated by Independent Radiologist | 9.07 mm | Standard Deviation 8.19 |
| Gadoteridol (ProHance) 0.2mmol/kg bw | Lesion Size Evaluated by Independent Radiologist | 8.83 mm | Standard Deviation 8.02 |
Secondary
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator
Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as confident in treatment planning with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator | Gadobutrol was better than ProHance | 9 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator | ProHance was better than gadobutrol | 21 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator | Both image sets were comparable | 58 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator | Gadobutrol was better than ProHance | 24 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator | ProHance was better than gadobutrol | 5 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator | Both image sets were comparable | 59 participants |
Secondary
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE
Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as confident in treatment planning with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE | Gadobutrol was better than ProHance | 26 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE | ProHance was better than gadobutrol | 15 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE | Both image sets were comparable | 24 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE | Gadobutrol was better than ProHance | 22 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE | ProHance was better than gadobutrol | 10 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE | Both image sets were comparable | 30 participants |
Secondary
Number of Participants With Reasons for Performance in SRS Planning by Investigator
Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as confident in treatment planning with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | Gadobutrol better: newly treatable lesions | 2 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | Gadobutrol was better: extended radiation area | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | Gadobutrol was better: clarified radiation area | 6 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | Gadobutrol was better: other | 1 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | ProHance was better: newly treatable lesions | 11 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | ProHance was better: extended radiation area | 1 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | ProHance was better: clarified radiation area | 8 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | ProHance was better: other | 3 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | ProHance was better: other | 0 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | Gadobutrol better: newly treatable lesions | 8 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | ProHance was better: newly treatable lesions | 3 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | Gadobutrol was better: extended radiation area | 1 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | ProHance was better: clarified radiation area | 2 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | Gadobutrol was better: clarified radiation area | 17 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | ProHance was better: extended radiation area | 0 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by Investigator | Gadobutrol was better: other | 1 participants |
Secondary
Number of Participants With Reasons for Performance in SRS Planning by TPE
Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as confident in treatment planning with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | Gadobutrol was better: newly detected lesions | 2 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | Gadobutrol was better: lesion size exceeds limit | 1 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | Gadobutrol better: newly treatable lesions | 5 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | Gadobutrol was better: extended radiation area | 8 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | Gadobutrol was better: clarified radiation area | 15 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | ProHance was better: newly detected lesions | 4 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | ProHance was better: lesion size exceeds the limit | 1 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | ProHance was better: newly treatable lesions | 4 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | ProHance was better: extended radiation area | 3 participants |
| Gadobutrol 0.1 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | ProHance was better: clarified radiation area | 8 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | ProHance was better: newly treatable lesions | 2 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | Gadobutrol was better: newly detected lesions | 5 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | ProHance was better: newly detected lesions | 1 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | Gadobutrol was better: lesion size exceeds limit | 0 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | ProHance was better: clarified radiation area | 3 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | Gadobutrol better: newly treatable lesions | 3 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | ProHance was better: lesion size exceeds the limit | 0 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | Gadobutrol was better: extended radiation area | 5 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | ProHance was better: extended radiation area | 5 participants |
| Gadobutrol 0.2 mmol/kg bw | Number of Participants With Reasons for Performance in SRS Planning by TPE | Gadobutrol was better: clarified radiation area | 11 participants |
Secondary
Score of Visibility Assessment - Border Delineation by Blinded Reader
Border delineation for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Score of Visibility Assessment - Border Delineation by Blinded Reader | 3.30 scores on a scale | Standard Deviation 0.46 |
| Gadobutrol 0.2 mmol/kg bw | Score of Visibility Assessment - Border Delineation by Blinded Reader | 3.45 scores on a scale | Standard Deviation 0.48 |
| Gadoteridol (ProHance) 0.2mmol/kg bw | Score of Visibility Assessment - Border Delineation by Blinded Reader | 3.36 scores on a scale | Standard Deviation 0.56 |
Secondary
Score of Visibility Assessment - Border Delineation by Investigator
Border delineation for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Score of Visibility Assessment - Border Delineation by Investigator | 3.10 scores on a scale | Standard Deviation 0.7 |
| Gadobutrol 0.2 mmol/kg bw | Score of Visibility Assessment - Border Delineation by Investigator | 3.38 scores on a scale | Standard Deviation 0.61 |
| Gadoteridol (ProHance) 0.2mmol/kg bw | Score of Visibility Assessment - Border Delineation by Investigator | 3.22 scores on a scale | Standard Deviation 0.68 |
Secondary
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader
Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader | 3.44 scores on a scale | Standard Deviation 0.42 |
| Gadobutrol 0.2 mmol/kg bw | Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader | 3.54 scores on a scale | Standard Deviation 0.44 |
| Gadoteridol (ProHance) 0.2mmol/kg bw | Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader | 3.51 scores on a scale | Standard Deviation 0.49 |
Secondary
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator
Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator | 3.16 scores on a scale | Standard Deviation 0.63 |
| Gadobutrol 0.2 mmol/kg bw | Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator | 3.46 scores on a scale | Standard Deviation 0.55 |
| Gadoteridol (ProHance) 0.2mmol/kg bw | Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator | 3.31 scores on a scale | Standard Deviation 0.63 |
Secondary
Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
Treatment planning confidence evaluated separately for each image set (gadobutrol 0.1 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-not confident, Pro-not confident | 1 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-not confident, Pro-confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-not confident, Pro-not assessable | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-confident, Pro-not confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-confident, Pro-confident | 149 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-confident, Pro-not assessable | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-not assessable, Pro-not confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-not assessable, Pro-confident | 1 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-not assessable, Pro-not assessable | 0 participants |
Secondary
Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)
Treatment planning confidence evaluated separately for each image set (gadobutrol \[Gado-\] 0.1 mmol/kg bw and gadoteridol \[Pro-\] 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE) | Gado-not confident, Pro-not confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE) | Gado-not confident, Pro-confident | 2 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE) | Gado-not confident, Pro-not assessable | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE) | Gado-confident, Pro-not confident | 1 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE) | Gado-confident, Pro-confident | 148 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE) | Gado-confident, Pro-not assessable | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE) | Gado-not assessable, Pro-not confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE) | Gado-not assessable, Pro-confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE) | Gado-not assessable, Pro-not assessable | 0 participants |
Secondary
Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-not confident, Pro-not confident | 1 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-not confident, Pro-confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-not confident, Pro-not assessable | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-confident, Pro-not confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-confident, Pro-confident | 149 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-confident, Pro-not assessable | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-not assessable, Pro-not confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-not assessable, Pro-confident | 1 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator | Gado-not assessable, Pro-not assessable | 0 participants |
Secondary
Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE
Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)
Time frame: one day
Population: Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE | Gado-not confident, Pro-not confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE | Gado-not confident, Pro-confident | 1 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE | Gado-not confident, Pro-not assessable | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE | Gado-confident, Pro-not confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE | Gado-confident, Pro-confident | 150 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE | Gado-confident, Pro-not assessable | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE | Gado-not assessable, Pro-not confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE | Gado-not assessable, Pro-confident | 0 participants |
| Gadobutrol 0.1 mmol/kg bw | Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE | Gado-not assessable, Pro-not assessable | 0 participants |