Trial Outcomes & Findings for SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study (NCT NCT00522951)
NCT ID: NCT00522951
Last Updated: 2017-08-28
Results Overview
Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator
COMPLETED
PHASE3
165 participants
one day
2017-08-28
Participant Flow
A total of 175 participants were enrolled into the study. 10 were withdrawn from the study before entering Study Period 1.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.
Participant milestones
| Measure |
Gadobutrol Then Gadoteridol
Participants who received two injections of gadobutrol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadoteridol 0.1 mmol/kg bw in Period 2
|
Gadoteridol Then Gadobutrol
Participants who received two injections of gadoteridol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadobutrol 0.1 mmol/kg bw in Period 2
|
|---|---|---|
|
Period 1
STARTED
|
86
|
79
|
|
Period 1
Received Treatment
|
86
|
78
|
|
Period 1
COMPLETED
|
86
|
78
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
|
Washout Period
STARTED
|
86
|
78
|
|
Washout Period
COMPLETED
|
86
|
76
|
|
Washout Period
NOT COMPLETED
|
0
|
2
|
|
Period 2
STARTED
|
86
|
76
|
|
Period 2
Subjects Received Treatment
|
84
|
75
|
|
Period 2
COMPLETED
|
84
|
75
|
|
Period 2
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Gadobutrol Then Gadoteridol
Participants who received two injections of gadobutrol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadoteridol 0.1 mmol/kg bw in Period 2
|
Gadoteridol Then Gadobutrol
Participants who received two injections of gadoteridol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadobutrol 0.1 mmol/kg bw in Period 2
|
|---|---|---|
|
Period 1
body motion
|
0
|
1
|
|
Washout Period
Adverse Event
|
0
|
1
|
|
Washout Period
Death
|
0
|
1
|
|
Period 2
Withdrawal by Subject
|
1
|
0
|
|
Period 2
residual contrast medium
|
1
|
1
|
Baseline Characteristics
SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=164 Participants
includes all participants received treatment
|
|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=99 Participants
|
|
Height
|
160.9 cm
STANDARD_DEVIATION 8.7 • n=99 Participants
|
|
Body weight
|
56.7 kg
STANDARD_DEVIATION 12.2 • n=99 Participants
|
|
Primary focus
Lung cancer
|
123 participants
n=99 Participants
|
|
Primary focus
Breast cancer
|
20 participants
n=99 Participants
|
|
Primary focus
Others
|
21 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: one dayPopulation: 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.
Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=151 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
n=151 Participants
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
n=151 Participants
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
Number of Lesions Detected by Blinded Readers (BR) and Investigator
averaged blinded reader
|
6.28 lesions
Standard Deviation 8.31
|
6.92 lesions
Standard Deviation 8.69
|
6.87 lesions
Standard Deviation 8.65
|
|
Number of Lesions Detected by Blinded Readers (BR) and Investigator
investigator
|
6.36 lesions
Standard Deviation 8.26
|
6.87 lesions
Standard Deviation 8.49
|
6.66 lesions
Standard Deviation 8.41
|
SECONDARY outcome
Timeframe: one dayPopulation: 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.
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)
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=143 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
n=148 Participants
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
n=149 Participants
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader
|
3.44 scores on a scale
Standard Deviation 0.42
|
3.54 scores on a scale
Standard Deviation 0.44
|
3.51 scores on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: one dayPopulation: 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.
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)
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=143 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
n=143 Participants
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
n=144 Participants
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator
|
3.16 scores on a scale
Standard Deviation 0.63
|
3.46 scores on a scale
Standard Deviation 0.55
|
3.31 scores on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: one dayPopulation: 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.
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)
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=143 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
n=148 Participants
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
n=149 Participants
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
Score of Visibility Assessment - Border Delineation by Blinded Reader
|
3.30 scores on a scale
Standard Deviation 0.46
|
3.45 scores on a scale
Standard Deviation 0.48
|
3.36 scores on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: one dayPopulation: 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.
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)
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=143 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
n=143 Participants
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
n=144 Participants
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
Score of Visibility Assessment - Border Delineation by Investigator
|
3.10 scores on a scale
Standard Deviation 0.70
|
3.38 scores on a scale
Standard Deviation 0.61
|
3.22 scores on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: one dayPopulation: 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.
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)
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=151 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 outcome
Timeframe: one dayPopulation: 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.
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)
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=151 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 outcome
Timeframe: one dayPopulation: 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.
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)
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=151 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
SECONDARY outcome
Timeframe: one dayPopulation: 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.
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)
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=151 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 outcome
Timeframe: one dayPopulation: 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
Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=65 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
n=62 Participants
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE
Gadobutrol was better than ProHance
|
26 participants
|
22 participants
|
—
|
|
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE
ProHance was better than gadobutrol
|
15 participants
|
10 participants
|
—
|
|
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE
Both image sets were comparable
|
24 participants
|
30 participants
|
—
|
SECONDARY outcome
Timeframe: one dayPopulation: 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
Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=88 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
n=88 Participants
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator
Gadobutrol was better than ProHance
|
9 participants
|
24 participants
|
—
|
|
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator
ProHance was better than gadobutrol
|
21 participants
|
5 participants
|
—
|
|
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator
Both image sets were comparable
|
58 participants
|
59 participants
|
—
|
SECONDARY outcome
Timeframe: one dayPopulation: 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
Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=65 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
n=62 Participants
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
Number of Participants With Reasons for Performance in SRS Planning by TPE
Gadobutrol was better: newly detected lesions
|
2 participants
|
5 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by TPE
Gadobutrol was better: lesion size exceeds limit
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by TPE
Gadobutrol better: newly treatable lesions
|
5 participants
|
3 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by TPE
Gadobutrol was better: extended radiation area
|
8 participants
|
5 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by TPE
Gadobutrol was better: clarified radiation area
|
15 participants
|
11 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by TPE
ProHance was better: newly detected lesions
|
4 participants
|
1 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by TPE
ProHance was better: lesion size exceeds the limit
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by TPE
ProHance was better: newly treatable lesions
|
4 participants
|
2 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by TPE
ProHance was better: extended radiation area
|
3 participants
|
5 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by TPE
ProHance was better: clarified radiation area
|
8 participants
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: one dayPopulation: 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
Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=88 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
n=88 Participants
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
Number of Participants With Reasons for Performance in SRS Planning by Investigator
Gadobutrol better: newly treatable lesions
|
2 participants
|
8 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by Investigator
Gadobutrol was better: extended radiation area
|
0 participants
|
1 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by Investigator
Gadobutrol was better: clarified radiation area
|
6 participants
|
17 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by Investigator
Gadobutrol was better: other
|
1 participants
|
1 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by Investigator
ProHance was better: newly treatable lesions
|
11 participants
|
3 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by Investigator
ProHance was better: extended radiation area
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by Investigator
ProHance was better: clarified radiation area
|
8 participants
|
2 participants
|
—
|
|
Number of Participants With Reasons for Performance in SRS Planning by Investigator
ProHance was better: other
|
3 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: one dayPopulation: 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.
Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=151 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
n=151 Participants
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
n=151 Participants
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
Lesion Size Evaluated by Independent Radiologist
|
8.79 mm
Standard Deviation 8.06
|
9.07 mm
Standard Deviation 8.19
|
8.83 mm
Standard Deviation 8.02
|
SECONDARY outcome
Timeframe: one dayPopulation: 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.
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)
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=151 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
n=151 Participants
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
n=151 Participants
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist
|
36.74 CNR
Standard Deviation 47.82
|
60.09 CNR
Standard Deviation 67.40
|
53.01 CNR
Standard Deviation 56.20
|
SECONDARY outcome
Timeframe: one dayPopulation: 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.
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.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg bw
n=151 Participants
Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
|
Gadobutrol 0.2 mmol/kg bw
n=151 Participants
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
Gadoteridol (ProHance) 0.2mmol/kg bw
n=151 Participants
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
|
|---|---|---|---|
|
Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions
|
0.963 ICC
|
0.955 ICC
|
0.949 ICC
|
Adverse Events
Gadobutrol Period
ProHance Period
Serious adverse events
| Measure |
Gadobutrol Period
n=161 participants at risk
Participants received two injections (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
|
ProHance Period
n=162 participants at risk
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
|
|---|---|---|
|
General disorders
General physical health deterioration
|
0.00%
0/161
|
0.62%
1/162
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/161
|
0.62%
1/162
|
Other adverse events
| Measure |
Gadobutrol Period
n=161 participants at risk
Participants received two injections (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
|
ProHance Period
n=162 participants at risk
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/161
|
1.2%
2/162
|
|
Gastrointestinal disorders
Vomiting
|
0.62%
1/161
|
1.2%
2/162
|
|
Investigations
Glucose urine present
|
0.00%
0/161
|
1.2%
2/162
|
|
Nervous system disorders
Headache
|
0.00%
0/161
|
1.2%
2/162
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.62%
1/161
|
1.2%
2/162
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60