Magnetic Resonance Imaging
Conditions
Keywords
MRI agents, Magnevist
Brief summary
The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to \< 2 years of age
Detailed description
Safety issues are addressed in the AE section
Interventions
DRUGGadopentetate 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: 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)).
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 23 Months
Healthy volunteers
No
Inclusion criteria
* Age: 2 months to \< 2 years (23 months) * Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI * Able to comply with the study procedures
Exclusion criteria
* Clinical unstable participants (eg, intensive care unit) * Renal Insufficiency * Participants undergoing chemotherapy \</= 48 hours prior to and up to 24 hours after the administration of Magnevist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set) | Within 5 minutes after injection | 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. |
| Dose Determined by Blinded Readers to be Superior for Diagnosis | Within 5 minutes after injection | Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters |
| Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | Within 5 minutes after injection | 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. |
| PK Analysis - Total Clearance (CL) | 20 to 45 min and 4 to 8 hours post injection | 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. |
| PK Analysis - Total Clearance (CL)/Body Weight (BW) | 20 to 45 min and 4 to 8 hours post injection | CL/BW = total clearance normalized by BW |
| PK Analysis - Volume of Distribution at Steady State (Vss) | 20 to 45 min and 4 to 8 hours post injection | 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. |
| PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW) | 20 to 45 min and 4 to 8 hours post injection | Vss/BW = volume of distribution at steady state normalized by body weight |
| PK Analysis - Area Under the Drug Concentration-time Curve (AUC) | Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity. | AUC = Area under the drug concentration-time curve from administration to infinity |
| PK Analysis - t 1/2 | 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 infinity | t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2 | Within 5 minutes after injection | 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 |
| Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 | Within 5 minutes after injection | 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. |
| Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2 | Within 5 minutes after injection | 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 |
| Number of Participants With Diagnostic Confidence - Stage 1 | Within 5 minutes after injection | 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 |
| Number of Participants With Diagnostic Confidence - Stage 2 | Within 5 minutes after injection | 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 |
| Number of Participants With Number of Lesions Detected - Stage 1 | Within 5 minutes after injection | 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. |
| Management Based on Unenhanced Images - Stage 2 | Within 5 minutes before injection | For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators. |
| Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1 | Within 5 minutes after injection | 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. |
| Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2 | Within 5 minutes after injection | 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. |
| Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | Within 5 minutes after injection | 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 |
| Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2 | Within 5 minutes after injection | 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 |
| Management Based on Unenhanced Images - Stage 1 | Within 5 minutes before injection | For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators. |
| Number of Participants With Number of Lesions Detected - Stage 2 | Within 5 minutes after injection | 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. |
| Number of Participants With Quality of Lesion Visualization - Stage 1 | Within 5 minutes after injection | 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) |
| Number of Participants With Quality of Lesion Visualization - Stage 2 | Within 5 minutes after injection | 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) |
| Number of Participants With Quality of Border Delineation - Stage 1 | Within 5 minutes after injection | 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 |
| Number of Participants With Quality of Border Delineation - Stage 2 | Within 5 minutes after injection | 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 |
| Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 | Within 5 minutes after injection | 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 |
| Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 | Within 5 minutes after injection | 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 |
| Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 | Within 5 minutes after injection | 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 |
Countries
Germany, United States
Participant flow
Recruitment details
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
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - 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). | 20 |
| Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 2 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)). | 34 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Stage 2 | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Total | Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 2 | Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 1 |
|---|---|---|---|
| Age, Customized 12 months to 2 years | 20 Participants | 12 Participants | 8 Participants |
| Age, Customized 2 to 6 months | 17 Participants | 11 Participants | 6 Participants |
| Age, Customized 6 to 12 months | 17 Participants | 11 Participants | 6 Participants |
| Body Weight | 8.1 kg STANDARD_DEVIATION 2.2 | 8.0 kg STANDARD_DEVIATION 2 | 8.4 kg STANDARD_DEVIATION 2.6 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 52 Participants | 33 Participants | 19 Participants |
| Sex: Female, Male Female | 26 Participants | 13 Participants | 13 Participants |
| Sex: Female, Male Male | 28 Participants | 21 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 20 | 2 / 34 |
| serious Total, serious adverse events | 4 / 20 | 8 / 34 |
Outcome results
Primary
Dose Determined by Blinded Readers to be Superior for Diagnosis
Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters
Time frame: Within 5 minutes after injection
Population: Primary analysis set (the first 5 PPS participants in each age group)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Dose Determined by Blinded Readers to be Superior for Diagnosis | Reader 1, 0.05 mmol/kg | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Dose Determined by Blinded Readers to be Superior for Diagnosis | Reader 2, 0.05 mmol/kg | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Dose Determined by Blinded Readers to be Superior for Diagnosis | Reader 3, 0.05 mmol/kg | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Dose Determined by Blinded Readers to be Superior for Diagnosis | Reader 1, 0.1 mmol/kg | 15 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Dose Determined by Blinded Readers to be Superior for Diagnosis | Reader 2, 0.1 mmol/kg | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Dose Determined by Blinded Readers to be Superior for Diagnosis | Reader 3, 0.1 mmol/kg | 9 Participants |
Primary
Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
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.
Time frame: Within 5 minutes after injection
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set) | No | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set) | Yes | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set) | No | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set) | Yes | 3 Participants |
Primary
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
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.
Time frame: Within 5 minutes after injection
Population: Primary Analysis Set (the first 5 PPS participants in each age group)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 2 - Contrast enhancement | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 3 - Contrast enhancement | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 1 - Border delineation | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 2 - Border delineation | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 3 - Border delineation | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 1 - Internal morphology | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 2 - Internal morphology | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 3 - Internal morphology | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 1 - Diagnostic information | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 2 - Diagnostic information | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 3 - Diagnostic information | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 1 - Contrast enhancement | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 3 - Diagnostic information | 9 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 2 - Contrast enhancement | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 2 - Internal morphology | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 3 - Contrast enhancement | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 2 - Diagnostic information | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 1 - Border delineation | 15 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 3 - Internal morphology | 9 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 2 - Border delineation | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 1 - Contrast enhancement | 15 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 3 - Border delineation | 9 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 1 - Diagnostic information | 15 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | BR 1 - Internal morphology | 15 Participants |
Primary
PK Analysis - Area Under the Drug Concentration-time Curve (AUC)
AUC = Area under the drug concentration-time curve from administration to infinity
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | PK Analysis - Area Under the Drug Concentration-time Curve (AUC) | 777.5 µmol•hour/Liter |
Primary
PK Analysis - t 1/2
t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity
Time frame: 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 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | PK Analysis - t 1/2 | 1.483 hour |
Primary
PK Analysis - Total Clearance (CL)
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.
Time frame: 20 to 45 min and 4 to 8 hours post injection
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | PK Analysis - Total Clearance (CL) | 1.012 Liters/hour |
Primary
PK Analysis - Total Clearance (CL)/Body Weight (BW)
CL/BW = total clearance normalized by BW
Time frame: 20 to 45 min and 4 to 8 hours post injection
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | PK Analysis - Total Clearance (CL)/Body Weight (BW) | 0.129 Liters/hour/kg |
Primary
PK Analysis - Volume of Distribution at Steady State (Vss)
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.
Time frame: 20 to 45 min and 4 to 8 hours post injection
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | PK Analysis - Volume of Distribution at Steady State (Vss) | 1.784 Liters |
Primary
PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)
Vss/BW = volume of distribution at steady state normalized by body weight
Time frame: 20 to 45 min and 4 to 8 hours post injection
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW) | 0.232 Liters/kg |
Secondary
Management Based on Unenhanced Images - Stage 1
For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.
Time frame: Within 5 minutes before injection
Population: Full analysis set (only participants for whom information on management was given)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Management Based on Unenhanced Images - Stage 1 | biopsy | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Management Based on Unenhanced Images - Stage 1 | surgery | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Management Based on Unenhanced Images - Stage 1 | follow-up | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Management Based on Unenhanced Images - Stage 1 | medical treatment | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Management Based on Unenhanced Images - Stage 1 | imaging | 10 Participants |
Secondary
Management Based on Unenhanced Images - Stage 2
For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.
Time frame: Within 5 minutes before injection
Population: Full analysis set (only participants for whom information on management was given)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Management Based on Unenhanced Images - Stage 2 | follow-up | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Management Based on Unenhanced Images - Stage 2 | imaging | 30 Participants |
Secondary
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
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
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 | Reader 1 - No lesion | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 | Reader 2 - No lesion | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 | Reader 3 - No lesion | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 | CI - No lesion | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 | Reader 1 - Brain lesion | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 | Reader 2 - Brain lesion | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 | Reader 3 - Brain lesion | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 | CI - Brain lesion | 7 Participants |
Secondary
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
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
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 | Reader 1 - No lesion | 13 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 | Reader 2 - No lesion | 12 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 | Reader 3 - No lesion | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 | CI - No lesion | 11 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 | Reader 1 - Brain lesion | 9 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 | Reader 2 - Brain lesion | 10 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 | Reader 3 - Brain lesion | 10 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 | CI - Brain lesion | 10 Participants |
Secondary
Number of Participants With Diagnostic Confidence - Stage 1
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
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 1 - very confident | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 2 - very confident | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | CI - not confident | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 3 - very confident | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | CI - very confident | 9 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 1 - not confident | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 1 - confident | 17 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 2 - not confident | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 2 - confident | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 3 - confident | 13 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 3 - not confident | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | CI - confident | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 3 - not confident | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 1 - very confident | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 1 - not confident | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 1 - confident | 17 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 2 - very confident | 13 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 3 - confident | 13 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | CI - confident | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 3 - very confident | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | CI - not confident | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 2 - confident | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | CI - very confident | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 2 - not confident | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | CI - very confident | 19 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 1 - not confident | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 3 - not confident | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | CI - not confident | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 1 - confident | 17 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 2 - confident | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 3 - confident | 10 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | CI - confident | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 1 - very confident | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 2 - very confident | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 3 - very confident | 9 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 1 | BR 2 - not confident | 0 Participants |
Secondary
Number of Participants With Diagnostic Confidence - Stage 2
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
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 1 - not confident | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 2 - not confident | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 3 - not confident | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | CI - not confident | 10 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 1 - confident | 28 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 2 - confident | 23 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 3 - confident | 27 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | CI - confident | 18 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 1 - very confident | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 2 - very confident | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 3 - very confident | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | CI - very confident | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 3 - very confident | 26 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 1 - not confident | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 3 - confident | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 2 - not confident | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 2 - very confident | 29 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 3 - not confident | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | CI - confident | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | CI - not confident | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | CI - very confident | 30 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 1 - confident | 18 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 1 - very confident | 16 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Diagnostic Confidence - Stage 2 | BR 2 - confident | 4 Participants |
Secondary
Number of Participants With Number of Lesions Detected - Stage 1
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.
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 1 - 1 lesion | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 2 - 0 lesions | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 3 - 0 lesions | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | CI - 0 lesions | 11 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 1 - 0 lesions | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 2 - 1 lesion | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 3 - 1 lesion | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | CI - 1 lesion | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 1 - 2 lesions | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 2 - 2 lesions | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 3 - 2 lesions | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | CI - 2 lesions | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 1 - 3 or more lesions | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 2 - 3 or more lesions | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 3 - 3 or more lesions | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | CI - 3 or more lesions | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 2 - 1 lesion | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 3 - 1 lesion | 10 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | CI - 1 lesion | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 2 - 3 or more lesions | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 1 - 2 lesions | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 2 - 2 lesions | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | CI - 3 or more lesions | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 3 - 2 lesions | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 1 - 0 lesions | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 3 - 3 or more lesions | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 2 - 0 lesions | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | CI - 2 lesions | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 3 - 0 lesions | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | CI - 0 lesions | 11 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 1 - 1 lesion | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 1 - 3 or more lesions | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 3 - 2 lesions | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 2 - 1 lesion | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 1 - 3 or more lesions | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 3 - 0 lesions | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 3 - 1 lesion | 9 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | CI - 3 or more lesions | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 1 - 0 lesions | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | CI - 1 lesion | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | CI - 2 lesions | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 1 - 1 lesion | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 1 - 2 lesions | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 2 - 3 or more lesions | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 2 - 0 lesions | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 2 - 2 lesions | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | CI - 0 lesions | 11 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 1 | BR 3 - 3 or more lesions | 4 Participants |
Secondary
Number of Participants With Number of Lesions Detected - Stage 2
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.
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 1 - 0 lesions | 13 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 2 - 0 lesions | 12 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 3 - 0 lesions | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | CI - 0 lesions | 17 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 1 - 1 lesions | 18 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 2 - 1 lesions | 15 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 3 - 1 lesions | 11 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | CI - 1 lesions | 15 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 1 - 2 lesions | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 2 - 2 lesions | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 3 - 2 lesions | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | CI - 2 lesions | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 1 - 3 or more lesions | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 2 - 3 or more lesions | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 3 - 3 or more lesions | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | CI - 3 or more lesions | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | CI - 3 or more lesions | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 1 - 0 lesions | 13 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 1 - 2 lesions | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 2 - 0 lesions | 11 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 1 - 3 or more lesions | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 3 - 0 lesions | 10 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 2 - 2 lesions | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | CI - 0 lesions | 15 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 3 - 3 or more lesions | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 1 - 1 lesions | 17 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 3 - 2 lesions | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 2 - 1 lesions | 16 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 2 - 3 or more lesions | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | BR 3 - 1 lesions | 13 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | CI - 2 lesions | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Number of Lesions Detected - Stage 2 | CI - 1 lesions | 15 Participants |
Secondary
Number of Participants With Quality of Border Delineation - Stage 1
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
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 1 - Excellent (1) | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 2 - Excellent (1) | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 3 - Excellent (1) | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | CI - Excellent (1) | 12 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 1 - Fair but adequate (2) | 15 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 2 - Fair but adequate (2) | 16 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 3 - Fair but adequate (2) | 13 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | CI - Fair but adequate (2) | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 1 - Poor (3) | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 2 - Poor (3) | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 3 - Poor (3) | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | CI - Poor (3) | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | CI - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 1 - Excellent (1) | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 3 - Fair but adequate (2) | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 1 - Poor (3) | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 2 - Excellent (1) | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 2 - Fair but adequate (2) | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 3 - Poor (3) | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 3 - Excellent (1) | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | CI - Fair but adequate (2) | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 1 - Fair but adequate (2) | 13 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | CI - Excellent (1) | 16 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 2 - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | CI - Excellent (1) | 19 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 1 - Fair but adequate (2) | 9 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 2 - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 2 - Fair but adequate (2) | 12 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 3 - Fair but adequate (2) | 15 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | CI - Fair but adequate (2) | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 3 - Poor (3) | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 1 - Excellent (1) | 10 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 2 - Excellent (1) | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 1 - Poor (3) | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | BR 3 - Excellent (1) | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 1 | CI - Poor (3) | 0 Participants |
Secondary
Number of Participants With Quality of Border Delineation - Stage 2
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
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 1 - Excellent (1) | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 2 - Excellent (1) | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 3 - Excellent (1) | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | CI - Excellent (1) | 12 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 1 - Fair but adequate (2) | 24 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 2 - Fair but adequate (2) | 28 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 3 - Fair but adequate (2) | 25 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | CI - Fair but adequate (2) | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 1 - Poor (3) | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 2 - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 3 - Poor (3) | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | CI - Poor (3) | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 3 - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 1 - Excellent (1) | 21 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 3 - Fair but adequate (2) | 10 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 2 - Excellent (1) | 17 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 2 - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 3 - Excellent (1) | 24 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | CI - Fair but adequate (2) | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | CI - Excellent (1) | 32 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | CI - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 1 - Fair but adequate (2) | 12 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 1 - Poor (3) | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Border Delineation - Stage 2 | BR 2 - Fair but adequate (2) | 17 Participants |
Secondary
Number of Participants With Quality of Lesion Visualization - Stage 1
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)
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 1 - Excellent (1) | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 2 - Excellent (1) | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 3 - Excellent (1) | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | CI - Excellent (1) | 12 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 1 - Fair but adequate (2) | 16 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 2 - Fair but adequate (2) | 17 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 3 - Fair but adequate (2) | 16 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | CI - Fair but adequate (2) | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 1 - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 2 - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 3 - Poor (3) | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | CI - Poor (3) | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | CI - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 1 - Excellent (1) | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 3 - Fair but adequate (2) | 15 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 1 - Poor (3) | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 2 - Excellent (1) | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 2 - Fair but adequate (2) | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 3 - Poor (3) | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 3 - Excellent (1) | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | CI - Fair but adequate (2) | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 1 - Fair but adequate (2) | 12 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | CI - Excellent (1) | 16 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 2 - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | CI - Excellent (1) | 20 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 1 - Fair but adequate (2) | 10 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 2 - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 2 - Fair but adequate (2) | 12 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 3 - Fair but adequate (2) | 15 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | CI - Fair but adequate (2) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 3 - Poor (3) | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 1 - Excellent (1) | 9 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 2 - Excellent (1) | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 1 - Poor (3) | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR 3 - Excellent (1) | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 1 | CI - Poor (3) | 0 Participants |
Secondary
Number of Participants With Quality of Lesion Visualization - Stage 2
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)
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 1 - Excellent (1) | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 2 - Excellent (1) | 7 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 3 - Excellent (1) | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | CI - Excellent (1) | 12 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 1 - Fair but adequate (2) | 25 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 2 - Fair but adequate (2) | 27 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 3 - Fair but adequate (2) | 28 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | CI - Fair but adequate (2) | 14 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 1 - Poor (3) | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 2 - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 3 - Poor (3) | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | CI - Poor (3) | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 3 - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 1 - Excellent (1) | 25 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 3 - Fair but adequate (2) | 16 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 2 - Excellent (1) | 25 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 2 - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 3 - Excellent (1) | 18 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | CI - Fair but adequate (2) | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | CI - Excellent (1) | 32 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | CI - Poor (3) | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 1 - Fair but adequate (2) | 8 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 1 - Poor (3) | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR 2 - Fair but adequate (2) | 9 Participants |
Secondary
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1
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
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | from follow-up to surgery | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | from imaging to surgery | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | from imaging to follow-up | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | from imaging to imaging | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | from imaging to other | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | from other to follow-up | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | from imaging to other | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | from follow-up to surgery | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | from imaging to imaging | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | from imaging to surgery | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | from other to follow-up | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | from imaging to follow-up | 1 Participants |
Secondary
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2
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
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2 | from imaging to surgery | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2 | from imaging to follow-up | 16 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2 | from imaging to medical treatment | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2 | from imaging to imaging | 3 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2 | from imaging to other | 7 Participants |
Secondary
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
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.
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 1 - from other to other | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 1 - from metastasis to metastasis | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 3 - from liver lesion to metastasis | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 1 - from metastasis to liver lesion | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 2 - from no lesion to vascular malformation | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 3 - from no lesion to vascular malformation | 0 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 3 - from no lesion to brain lesion | 2 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 1 - from other to other | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 1 - from metastasis to metastasis | 1 Participants |
Secondary
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
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
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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 |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2 | BR 2 - from other to other | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | 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
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1
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
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 1 | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 2 | 1 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 3 | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 | CI | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 | CI | 4 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 1 | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 3 | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 | BR 2 | 0 Participants |
Secondary
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2
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
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2 | BR 1 | 10 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2 | BR 2 | 6 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2 | BR 3 | 10 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2 | CI | 8 Participants |
Secondary
Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1
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.
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1 | 5 Participants |
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg) | Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1 | 12 Participants |
Secondary
Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2
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.
Time frame: Within 5 minutes after injection
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg) | Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2 | 30 Participants |