The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to \< 2 years of age
Safety issues are addressed in the AE section
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
54
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)).
Unnamed facility
San Diego, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
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
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
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
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
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
PK Analysis - Volume of Distribution at Steady State (Vss)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Iowa City, Iowa, United States
Unnamed facility
Kansas City, Missouri, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Akron, Ohio, United States
Unnamed facility
Hershey, Pennsylvania, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
Dresden, Saxony, Germany
...and 3 more locations
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
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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