Contrast-enhanced MRI in Children 2 Months to <2 Years
Open-label, Multi-center, Two-stage, Age Stratified, Pharmacokinetic, Safety, and Efficacy Study in Children 2 Months to < 2 Years of Age Undergoing Magnevist Injection Enhanced MRI
3 other identifiers
interventional
54
2 countries
13
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2010
Shorter than P25 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
October 13, 2011
CompletedNovember 18, 2015
October 1, 2015
8 months
July 10, 2009
September 8, 2011
October 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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.
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
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.
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.
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
20 to 45 min and 4 to 8 hours post injection
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.
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
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
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
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
Secondary Outcomes (20)
Number of Participants With Number of Lesions Detected - Stage 1
Within 5 minutes after injection
Number of Participants With Number of Lesions Detected - Stage 2
Within 5 minutes after injection
Number of Participants With Quality of Lesion Visualization - Stage 1
Within 5 minutes after injection
Number of Participants With Quality of Lesion Visualization - Stage 2
Within 5 minutes after injection
Number of Participants With Quality of Border Delineation - Stage 1
Within 5 minutes after injection
- +15 more secondary outcomes
Study Arms (1)
Gadopentetate dimeglumine (Magnevist, BAY86-6661)
EXPERIMENTALFor 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)).
Interventions
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)).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (13)
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Chicago, Illinois, 60614, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Kansas City, Missouri, 64108-9898, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Akron, Ohio, 44308, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Dresden, Saxony, 01307, Germany
Unknown Facility
Halle, Saxony-Anhalt, 06120, Germany
Unknown Facility
Kiel, Schleswig-Holstein, 24105, Germany
Unknown Facility
Jena, Thuringia, 07740, Germany
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2009
First Posted
July 13, 2009
Study Start
January 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
November 18, 2015
Results First Posted
October 13, 2011
Record last verified: 2015-10