Trial Outcomes & Findings for Contrast-enhanced MRI in Children 2 Months to <2 Years (NCT NCT00937391)
NCT ID: NCT00937391
Last Updated: 2015-11-18
Results Overview
A clinical judgment by the open-label Clinical Investigators (CIs) as to whether ("yes") or not ("no") the CI could make a diagnosis from the image.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
54 participants
Primary outcome timeframe
Within 5 minutes after injection
Results posted on
2015-11-18
Participant Flow
The date of the first participant, first visit was 21 Jan 2010. The date of the last participant, last visit was 09 Sep 2010. The date of the Blinded Read for Stage 1 was 27 Apr 2010. the date of the Blinded Read for Stage 2 was 08 Sep 2010
A subject was enrolled in EITHER Stage 1 or Stage 2 and not both. Overall for both stages, 61 participants were Screened, 7 were Screen Failures, and 54 participants were enrolled and treated of which 53 participants completed the study (20 unique participants in Stage 1 and 33 unique participants in Stage 2)
Participant milestones
| Measure |
Gadopentetate Dimeglumine (Magnevist, BAY86-6661)
For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Another group of participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
|
|---|---|
|
Stage 1
STARTED
|
20
|
|
Stage 1
Treated
|
20
|
|
Stage 1
COMPLETED
|
20
|
|
Stage 1
NOT COMPLETED
|
0
|
|
Stage 2
STARTED
|
34
|
|
Stage 2
Treated
|
34
|
|
Stage 2
COMPLETED
|
33
|
|
Stage 2
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Gadopentetate Dimeglumine (Magnevist, BAY86-6661)
For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Another group of participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
|
|---|---|
|
Stage 2
Withdrawal by Subject
|
1
|
Baseline Characteristics
Contrast-enhanced MRI in Children 2 Months to <2 Years
Baseline characteristics by cohort
| Measure |
Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 1
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 2
n=34 Participants
Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
2 to 6 months
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
6 to 12 months
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
12 months to 2 years
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body Weight
|
8.4 kg
STANDARD_DEVIATION 2.6 • n=5 Participants
|
8.0 kg
STANDARD_DEVIATION 2.0 • n=7 Participants
|
8.1 kg
STANDARD_DEVIATION 2.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Within 5 minutes after injectionPopulation: The first 3 participants of Stage 1 received 2 IV injections of 0.05 mmol/kg body weight (BW), images were obtained after each injection and an assessment made by the CIs as to diagnostic adequacy.
A clinical judgment by the open-label Clinical Investigators (CIs) as to whether ("yes") or not ("no") the CI could make a diagnosis from the image.
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=3 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=3 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
No
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
Yes
|
2 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Primary analysis set (the first 5 PPS participants in each age group)
Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=15 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Dose Determined by Blinded Readers to be Superior for Diagnosis
Reader 1, 0.05 mmol/kg
|
0 Participants
|
—
|
—
|
|
Dose Determined by Blinded Readers to be Superior for Diagnosis
Reader 2, 0.05 mmol/kg
|
1 Participants
|
—
|
—
|
|
Dose Determined by Blinded Readers to be Superior for Diagnosis
Reader 3, 0.05 mmol/kg
|
6 Participants
|
—
|
—
|
|
Dose Determined by Blinded Readers to be Superior for Diagnosis
Reader 1, 0.1 mmol/kg
|
15 Participants
|
—
|
—
|
|
Dose Determined by Blinded Readers to be Superior for Diagnosis
Reader 2, 0.1 mmol/kg
|
14 Participants
|
—
|
—
|
|
Dose Determined by Blinded Readers to be Superior for Diagnosis
Reader 3, 0.1 mmol/kg
|
9 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Primary Analysis Set (the first 5 PPS participants in each age group)
For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information. The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant. If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant. The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose.
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=15 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=15 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
BR 1 - Diagnostic information
|
0 Participants
|
15 Participants
|
—
|
|
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
BR 2 - Diagnostic information
|
1 Participants
|
14 Participants
|
—
|
|
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
BR 3 - Diagnostic information
|
6 Participants
|
9 Participants
|
—
|
|
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
BR 1 - Contrast enhancement
|
0 Participants
|
15 Participants
|
—
|
|
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
BR 2 - Contrast enhancement
|
1 Participants
|
14 Participants
|
—
|
|
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
BR 3 - Contrast enhancement
|
7 Participants
|
8 Participants
|
—
|
|
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
BR 1 - Border delineation
|
0 Participants
|
15 Participants
|
—
|
|
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
BR 2 - Border delineation
|
1 Participants
|
14 Participants
|
—
|
|
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
BR 3 - Border delineation
|
6 Participants
|
9 Participants
|
—
|
|
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
BR 1 - Internal morphology
|
0 Participants
|
15 Participants
|
—
|
|
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
BR 2 - Internal morphology
|
1 Participants
|
14 Participants
|
—
|
|
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
BR 3 - Internal morphology
|
6 Participants
|
9 Participants
|
—
|
PRIMARY outcome
Timeframe: 20 to 45 min and 4 to 8 hours post injectionPopulation: PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples
Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug.
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=44 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
PK Analysis - Total Clearance (CL)
|
1.012 Liters/hour
Interval 0.272 to 1.588
|
—
|
—
|
PRIMARY outcome
Timeframe: 20 to 45 min and 4 to 8 hours post injectionPopulation: PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples
CL/BW = total clearance normalized by BW
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=44 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
PK Analysis - Total Clearance (CL)/Body Weight (BW)
|
0.129 Liters/hour/kg
Interval 0.059 to 0.166
|
—
|
—
|
PRIMARY outcome
Timeframe: 20 to 45 min and 4 to 8 hours post injectionPopulation: PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples
Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=44 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
PK Analysis - Volume of Distribution at Steady State (Vss)
|
1.784 Liters
Interval 0.68 to 3.11
|
—
|
—
|
PRIMARY outcome
Timeframe: 20 to 45 min and 4 to 8 hours post injectionPopulation: PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples
Vss/BW = volume of distribution at steady state normalized by body weight
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=44 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)
|
0.232 Liters/kg
Interval 0.192 to 0.27
|
—
|
—
|
PRIMARY outcome
Timeframe: Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.Population: PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples
AUC = Area under the drug concentration-time curve from administration to infinity
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=44 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
PK Analysis - Area Under the Drug Concentration-time Curve (AUC)
|
777.5 µmol•hour/Liter
Interval 600.8 to 1686.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinityPopulation: PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples
t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=44 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
PK Analysis - t 1/2
|
1.483 hour
Interval 1.142 to 8.427
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=20 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Number of Lesions Detected - Stage 1
BR 1 - 0 lesions
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
BR 2 - 0 lesions
|
7 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
BR 3 - 0 lesions
|
8 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
CI - 0 lesions
|
11 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
BR 1 - 1 lesion
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
BR 2 - 1 lesion
|
8 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
BR 3 - 1 lesion
|
8 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
CI - 1 lesion
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
BR 1 - 2 lesions
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
BR 2 - 2 lesions
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
BR 3 - 2 lesions
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
CI - 2 lesions
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
BR 1 - 3 or more lesions
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
BR 2 - 3 or more lesions
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
BR 3 - 3 or more lesions
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Number of Lesions Detected - Stage 1
CI - 3 or more lesions
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=34 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=34 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Number of Lesions Detected - Stage 2
BR 1 - 0 lesions
|
13 Participants
|
13 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
BR 2 - 0 lesions
|
12 Participants
|
11 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
BR 3 - 0 lesions
|
14 Participants
|
10 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
CI - 0 lesions
|
17 Participants
|
15 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
BR 1 - 1 lesions
|
18 Participants
|
17 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
BR 2 - 1 lesions
|
15 Participants
|
16 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
BR 3 - 1 lesions
|
11 Participants
|
13 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
CI - 1 lesions
|
15 Participants
|
15 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
BR 1 - 2 lesions
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
BR 2 - 2 lesions
|
5 Participants
|
4 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
BR 3 - 2 lesions
|
3 Participants
|
4 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
CI - 2 lesions
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
BR 1 - 3 or more lesions
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
BR 2 - 3 or more lesions
|
2 Participants
|
3 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
BR 3 - 3 or more lesions
|
6 Participants
|
7 Participants
|
—
|
|
Number of Participants With Number of Lesions Detected - Stage 2
CI - 3 or more lesions
|
2 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=20 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Quality of Lesion Visualization - Stage 1
BR 1 - Excellent (1)
|
4 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants With Quality of Lesion Visualization - Stage 1
BR 2 - Excellent (1)
|
3 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With Quality of Lesion Visualization - Stage 1
BR 3 - Excellent (1)
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Quality of Lesion Visualization - Stage 1
CI - Excellent (1)
|
12 Participants
|
16 Participants
|
20 Participants
|
|
Number of Participants With Quality of Lesion Visualization - Stage 1
BR 1 - Fair but adequate (2)
|
16 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants With Quality of Lesion Visualization - Stage 1
BR 2 - Fair but adequate (2)
|
17 Participants
|
14 Participants
|
12 Participants
|
|
Number of Participants With Quality of Lesion Visualization - Stage 1
BR 3 - Fair but adequate (2)
|
16 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Quality of Lesion Visualization - Stage 1
CI - Fair but adequate (2)
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Quality of Lesion Visualization - Stage 1
BR 1 - Poor (3)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Quality of Lesion Visualization - Stage 1
BR 2 - Poor (3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Quality of Lesion Visualization - Stage 1
BR 3 - Poor (3)
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Quality of Lesion Visualization - Stage 1
CI - Poor (3)
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=34 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=34 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Quality of Lesion Visualization - Stage 2
BR 1 - Excellent (1)
|
3 Participants
|
25 Participants
|
—
|
|
Number of Participants With Quality of Lesion Visualization - Stage 2
BR 2 - Excellent (1)
|
7 Participants
|
25 Participants
|
—
|
|
Number of Participants With Quality of Lesion Visualization - Stage 2
BR 3 - Excellent (1)
|
5 Participants
|
18 Participants
|
—
|
|
Number of Participants With Quality of Lesion Visualization - Stage 2
CI - Excellent (1)
|
12 Participants
|
32 Participants
|
—
|
|
Number of Participants With Quality of Lesion Visualization - Stage 2
BR 1 - Fair but adequate (2)
|
25 Participants
|
8 Participants
|
—
|
|
Number of Participants With Quality of Lesion Visualization - Stage 2
BR 2 - Fair but adequate (2)
|
27 Participants
|
9 Participants
|
—
|
|
Number of Participants With Quality of Lesion Visualization - Stage 2
BR 3 - Fair but adequate (2)
|
28 Participants
|
16 Participants
|
—
|
|
Number of Participants With Quality of Lesion Visualization - Stage 2
CI - Fair but adequate (2)
|
14 Participants
|
2 Participants
|
—
|
|
Number of Participants With Quality of Lesion Visualization - Stage 2
BR 1 - Poor (3)
|
6 Participants
|
1 Participants
|
—
|
|
Number of Participants With Quality of Lesion Visualization - Stage 2
BR 2 - Poor (3)
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Quality of Lesion Visualization - Stage 2
BR 3 - Poor (3)
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Quality of Lesion Visualization - Stage 2
CI - Poor (3)
|
8 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=20 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Quality of Border Delineation - Stage 1
BR 1 - Excellent (1)
|
4 Participants
|
6 Participants
|
10 Participants
|
|
Number of Participants With Quality of Border Delineation - Stage 1
BR 2 - Excellent (1)
|
3 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With Quality of Border Delineation - Stage 1
BR 3 - Excellent (1)
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Quality of Border Delineation - Stage 1
CI - Excellent (1)
|
12 Participants
|
16 Participants
|
19 Participants
|
|
Number of Participants With Quality of Border Delineation - Stage 1
BR 1 - Fair but adequate (2)
|
15 Participants
|
13 Participants
|
9 Participants
|
|
Number of Participants With Quality of Border Delineation - Stage 1
BR 2 - Fair but adequate (2)
|
16 Participants
|
14 Participants
|
12 Participants
|
|
Number of Participants With Quality of Border Delineation - Stage 1
BR 3 - Fair but adequate (2)
|
13 Participants
|
14 Participants
|
15 Participants
|
|
Number of Participants With Quality of Border Delineation - Stage 1
CI - Fair but adequate (2)
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Quality of Border Delineation - Stage 1
BR 1 - Poor (3)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Quality of Border Delineation - Stage 1
BR 2 - Poor (3)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Quality of Border Delineation - Stage 1
BR 3 - Poor (3)
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Quality of Border Delineation - Stage 1
CI - Poor (3)
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=34 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=34 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Quality of Border Delineation - Stage 2
BR 1 - Excellent (1)
|
4 Participants
|
21 Participants
|
—
|
|
Number of Participants With Quality of Border Delineation - Stage 2
BR 2 - Excellent (1)
|
6 Participants
|
17 Participants
|
—
|
|
Number of Participants With Quality of Border Delineation - Stage 2
BR 3 - Excellent (1)
|
8 Participants
|
24 Participants
|
—
|
|
Number of Participants With Quality of Border Delineation - Stage 2
CI - Excellent (1)
|
12 Participants
|
32 Participants
|
—
|
|
Number of Participants With Quality of Border Delineation - Stage 2
BR 1 - Fair but adequate (2)
|
24 Participants
|
12 Participants
|
—
|
|
Number of Participants With Quality of Border Delineation - Stage 2
BR 2 - Fair but adequate (2)
|
28 Participants
|
17 Participants
|
—
|
|
Number of Participants With Quality of Border Delineation - Stage 2
BR 3 - Fair but adequate (2)
|
25 Participants
|
10 Participants
|
—
|
|
Number of Participants With Quality of Border Delineation - Stage 2
CI - Fair but adequate (2)
|
14 Participants
|
2 Participants
|
—
|
|
Number of Participants With Quality of Border Delineation - Stage 2
BR 1 - Poor (3)
|
6 Participants
|
1 Participants
|
—
|
|
Number of Participants With Quality of Border Delineation - Stage 2
BR 2 - Poor (3)
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Quality of Border Delineation - Stage 2
BR 3 - Poor (3)
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Quality of Border Delineation - Stage 2
CI - Poor (3)
|
8 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=20 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
Reader 1 - No lesion
|
4 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
Reader 2 - No lesion
|
7 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
Reader 3 - No lesion
|
8 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
CI - No lesion
|
6 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
Reader 1 - Brain lesion
|
8 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
Reader 2 - Brain lesion
|
6 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
Reader 3 - Brain lesion
|
4 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
CI - Brain lesion
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=34 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
Reader 1 - No lesion
|
13 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
Reader 2 - No lesion
|
12 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
Reader 3 - No lesion
|
14 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
CI - No lesion
|
11 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
Reader 1 - Brain lesion
|
9 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
Reader 2 - Brain lesion
|
10 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
Reader 3 - Brain lesion
|
10 Participants
|
—
|
—
|
|
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
CI - Brain lesion
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=20 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1
BR 1
|
6 Participants
|
6 Participants
|
—
|
|
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1
BR 2
|
1 Participants
|
0 Participants
|
—
|
|
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1
BR 3
|
6 Participants
|
6 Participants
|
—
|
|
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1
CI
|
4 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=34 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2
BR 1
|
10 Participants
|
—
|
—
|
|
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2
BR 2
|
6 Participants
|
—
|
—
|
|
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2
BR 3
|
10 Participants
|
—
|
—
|
|
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2
CI
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 1. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator.
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=20 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
BR 1 - from "metastasis" to "liver lesion"
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
BR 2 - from "no lesion" to "vascular malformation"
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
BR 3 - from "no lesion" to "vascular malformation"
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
BR 3 - from "no lesion" to "brain lesion"
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
BR 1 - from "vasc. malform." to "vasc. malfrom."
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
BR 1 - from "brain lesion" to "brain lesion"
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
BR 3 - from "brain lesion" to "brain lesion"
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
BR 1 - from "other" to "other"
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
BR 3 - from "other" to "vascular malformation"
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
BR 1 - from "metastasis" to "metastasis"
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
BR 3 - from "liver lesion" to "metastasis"
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 2. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=34 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 1 - from "no lesion" to "brain lesion"
|
1 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 2 - from "no lesion" to "other"
|
1 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 3 - from "no lesion" to "other"
|
2 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 3 - from "no lesion" to "infectious disorder"
|
2 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 1 - from "vasc. malform." to "vasc. malform."
|
1 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 1 - from "inf. disorder" to "inf. disorder"
|
1 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 1 - from "brain lesion" to "no lesion"
|
1 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 1 - from "brain lesion" to "inf. disorder"
|
1 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 1 - from "brain lesion" to "brain lesion"
|
4 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 2 - from "brain lesion" to "brain lesion"
|
1 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 3 - from "brain lesion" to "brain lesion"
|
2 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 2 - from "renal lesion" to "renal lesion"
|
1 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 3 - from "renal lesion" to "renal lesion"
|
1 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 3 - from "not assessable" to "other"
|
1 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 1 - from "other" to "vascular malformation"
|
1 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 2 - from "other" to "vascular malformation"
|
2 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 2 - from "other" to "other"
|
1 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
BR 3 - from "other" to "other"
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=20 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Diagnostic Confidence - Stage 1
BR 1 - not confident
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Diagnostic Confidence - Stage 1
BR 2 - not confident
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Diagnostic Confidence - Stage 1
BR 3 - not confident
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Diagnostic Confidence - Stage 1
CI - not confident
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Diagnostic Confidence - Stage 1
BR 1 - confident
|
17 Participants
|
17 Participants
|
17 Participants
|
|
Number of Participants With Diagnostic Confidence - Stage 1
BR 2 - confident
|
14 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Diagnostic Confidence - Stage 1
BR 3 - confident
|
13 Participants
|
13 Participants
|
10 Participants
|
|
Number of Participants With Diagnostic Confidence - Stage 1
CI - confident
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Diagnostic Confidence - Stage 1
BR 1 - very confident
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Diagnostic Confidence - Stage 1
BR 2 - very confident
|
3 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants With Diagnostic Confidence - Stage 1
BR 3 - very confident
|
5 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants With Diagnostic Confidence - Stage 1
CI - very confident
|
9 Participants
|
14 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=34 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=34 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Diagnostic Confidence - Stage 2
BR 1 - not confident
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diagnostic Confidence - Stage 2
BR 2 - not confident
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diagnostic Confidence - Stage 2
BR 3 - not confident
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diagnostic Confidence - Stage 2
CI - not confident
|
10 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diagnostic Confidence - Stage 2
BR 1 - confident
|
28 Participants
|
18 Participants
|
—
|
|
Number of Participants With Diagnostic Confidence - Stage 2
BR 2 - confident
|
23 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diagnostic Confidence - Stage 2
BR 3 - confident
|
27 Participants
|
8 Participants
|
—
|
|
Number of Participants With Diagnostic Confidence - Stage 2
CI - confident
|
18 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diagnostic Confidence - Stage 2
BR 1 - very confident
|
3 Participants
|
16 Participants
|
—
|
|
Number of Participants With Diagnostic Confidence - Stage 2
BR 2 - very confident
|
8 Participants
|
29 Participants
|
—
|
|
Number of Participants With Diagnostic Confidence - Stage 2
BR 3 - very confident
|
6 Participants
|
26 Participants
|
—
|
|
Number of Participants With Diagnostic Confidence - Stage 2
CI - very confident
|
6 Participants
|
30 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes before injectionPopulation: Full analysis set (only participants for whom information on management was given)
For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=18 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Management Based on Unenhanced Images - Stage 1
biopsy
|
1 Participants
|
—
|
—
|
|
Management Based on Unenhanced Images - Stage 1
surgery
|
2 Participants
|
—
|
—
|
|
Management Based on Unenhanced Images - Stage 1
follow-up
|
3 Participants
|
—
|
—
|
|
Management Based on Unenhanced Images - Stage 1
medical treatment
|
2 Participants
|
—
|
—
|
|
Management Based on Unenhanced Images - Stage 1
imaging
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes before injectionPopulation: Full analysis set (only participants for whom information on management was given)
For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=32 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Management Based on Unenhanced Images - Stage 2
follow-up
|
2 Participants
|
—
|
—
|
|
Management Based on Unenhanced Images - Stage 2
imaging
|
30 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
For Stage 1, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for both doses.
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=20 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1
|
5 Participants
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
For Stage 2, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for the optimal efficacious dose determined in Stage 1.
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=34 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2
|
30 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented for both doses in Stage 1
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=20 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
n=20 Participants
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1
from "follow-up" to "surgery"
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1
from "imaging" to "surgery"
|
2 Participants
|
3 Participants
|
—
|
|
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1
from "imaging" to "follow-up"
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1
from "imaging" to "imaging"
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1
from "imaging" to "other"
|
0 Participants
|
6 Participants
|
—
|
|
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1
from "other" to "follow-up"
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 5 minutes after injectionPopulation: Full analysis set
The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented in Stage 2 for the optimal efficacious dose determined in Stage 1
Outcome measures
| Measure |
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)
n=34 Participants
Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
|---|---|---|---|
|
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2
from "imaging" to "surgery"
|
3 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2
from "imaging" to "follow-up"
|
16 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2
from "imaging" to "medical treatment"
|
3 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2
from "imaging" to "imaging"
|
3 Participants
|
—
|
—
|
|
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2
from "imaging" to "other"
|
7 Participants
|
—
|
—
|
Adverse Events
Gadopentetate Dimeglumine - Stage 1
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Gadopentetate Dimeglumine - Stage 2
Serious events: 8 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gadopentetate Dimeglumine - Stage 1
n=20 participants at risk
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 2
n=34 participants at risk
Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
|
|---|---|---|
|
Congenital, familial and genetic disorders
Krabbe's disease
|
0.00%
0/20
|
2.9%
1/34
|
|
Congenital, familial and genetic disorders
Alagille syndrome
|
0.00%
0/20
|
2.9%
1/34
|
|
Congenital, familial and genetic disorders
Congenital aortic anomaly
|
0.00%
0/20
|
2.9%
1/34
|
|
Gastrointestinal disorders
Intestinal cyst
|
0.00%
0/20
|
2.9%
1/34
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20
|
0.00%
0/34
|
|
Infections and infestations
Bronchopneumonia
|
5.0%
1/20
|
0.00%
0/34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/20
|
2.9%
1/34
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
5.0%
1/20
|
0.00%
0/34
|
|
Nervous system disorders
Motor developmental delay
|
0.00%
0/20
|
2.9%
1/34
|
|
Renal and urinary disorders
Neurogenic bladder
|
5.0%
1/20
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/20
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.0%
1/20
|
0.00%
0/34
|
|
Surgical and medical procedures
Adenoidectomy
|
0.00%
0/20
|
2.9%
1/34
|
Other adverse events
| Measure |
Gadopentetate Dimeglumine - Stage 1
n=20 participants at risk
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
|
Gadopentetate Dimeglumine - Stage 2
n=34 participants at risk
Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
|
|---|---|---|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
5.0%
1/20
|
0.00%
0/34
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20
|
2.9%
1/34
|
|
General disorders
Pyrexia
|
15.0%
3/20
|
2.9%
1/34
|
|
Infections and infestations
Rhinitis
|
5.0%
1/20
|
0.00%
0/34
|
|
Nervous system disorders
Convulsion
|
5.0%
1/20
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20
|
0.00%
0/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60