Trial Condition(s):
Magnetic Resonance Imaging
Contrast-enhanced MRI in children 2 months to <2 years
Bayer Identifier:
91784
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to < 2 years of age
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Jena, Germany, 07740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Akron, United States, 44308 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Louis, United States, 63110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60614 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iowa City, United States, 52242 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halle, Germany, 06120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiel, Germany, 24105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aurora, United States, 80045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kansas City, United States, 64108-9898 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hershey, United States, 17033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Number of participants with diagnostic adequacy - open-label Clinical Investigators (Per Protocol Set)Timeframe: Within 5 minutes after injection
- Dose determined by Blinded Readers to be superior for diagnosisTimeframe: Within 5 minutes after injection
- Paired-dose comparison of number of participants with dose superiority determined for 4 lesion visualization variables - Blinded ReadersTimeframe: Within 5 minutes after injection
- PK analysis - total clearance (CL)Timeframe: 20 to 45 min and 4 to 8 h post injection
- PK analysis - total clearance (CL)/body weight (BW)Timeframe: 20 to 45 min and 4 to 8 h post injection
- PK analysis - volume of distribution at steady state (Vss)Timeframe: 20 to 45 min and 4 to 8 h post injection
- PK analysis - volume of distribution at steady state (Vss) /body weight (BW)Timeframe: 20 to 45 min and 4 to 8 h post injection
- PK analysis - Area under the drug concentration-time curve (AUC)Timeframe: Samples taken 20 to 45 min and 4 to 8 h post injection. AUC calculated from time of injection to infinity
- PK analysis - t 1/2Timeframe: Samples taken at 20 to 45 min and at 4 to 8 h post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity
Secondary Outcome
- Number of participants with number of lesions detected - Stage 1Timeframe: Within 5 minutes after injection
- Number of participants with number of lesions detected - Stage 2Timeframe: Within 5 minutes after injection
- Number of participants with quality of lesion visualization - Stage 1Timeframe: Within 5 minutes after injection
- Number of participants with quality of lesion visualization - Stage 2Timeframe: Within 5 minutes after injection
- Number of participants with quality of border delineation - Stage 1Timeframe: Within 5 minutes after injection
- Number of participants with quality of border delineation - Stage 2Timeframe: Within 5 minutes after injection
- Most frequent diagnostic findings with unenhanced images - Stage 1Timeframe: Within 5 minutes after injection
- Most frequent diagnostic findings with unenhanced images - Stage 2Timeframe: Within 5 minutes after injection
- Overall number of participants with change in diagnosis from unenhanced to combined images - Stage 1Timeframe: Within 5 minutes after injection
- Overall number of participants with change in diagnosis from unenhanced to combined images - Stage 2Timeframe: Within 5 minutes after injection
- Number of participants with specific change in the diagnosis from unenhanced to combined images - Stage 1Timeframe: Within 5 minutes after injection
- Number of participants with specific change in the diagnosis from unenhanced to combined images - Stage 2Timeframe: Within 5 minutes after injection
- Number of participants with diagnostic confidence - Stage 1Timeframe: Within 5 minutes after injection
- Number of participants with diagnostic confidence - Stage 2Timeframe: Within 5 minutes after injection
- Management based on unenhanced images - Stage 1Timeframe: Within 5 minutes after injection
- Management based on unenhanced images - Stage 2Timeframe: Within 5 minutes after injection
- Overall number of participants with change in management from unenhanced to combined images - Stage 1Timeframe: Within 5 minutes after injection
- Overall number of participants with change in management from unenhanced to combined images - Stage 2Timeframe: Within 5 minutes after injection
- Number of participants with specific change in management from unenhanced to combined images - Stage 1Timeframe: Within 5 minutes after injection
- Number of participants with specific change in management from unenhanced to combined images - Stage 2Timeframe: Within 5 minutes after injection
Additional Information
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