Clinical trial NCT00937391: Contrast-enhanced MRI in Children 2 Months to <2 Years
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Magnetic Resonance Imaging
Keywords: MRI agents
Magnevist
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 54
Sex: ALL
Minimum age (years): 2
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
timeFrame: Within 5 minutes after injection
measure: Dose Determined by Blinded Readers to be Superior for Diagnosis
timeFrame: Within 5 minutes after injection
measure: Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
timeFrame: Within 5 minutes after injection
measure: PK Analysis - Total Clearance (CL)
timeFrame: 20 to 45 min and 4 to 8 hours post injection
measure: PK Analysis - Total Clearance (CL)/Body Weight (BW)
timeFrame: 20 to 45 min and 4 to 8 hours post injection
measure: PK Analysis - Volume of Distribution at Steady State (Vss)
timeFrame: 20 to 45 min and 4 to 8 hours post injection
measure: PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)
timeFrame: 20 to 45 min and 4 to 8 hours post injection
measure: PK Analysis - Area Under the Drug Concentration-time Curve (AUC)
timeFrame: Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.
measure: PK Analysis - t 1/2
timeFrame: Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity
Secondary outcomes:
measure: Number of Participants With Number of Lesions Detected - Stage 1
timeFrame: Within 5 minutes after injection
measure: Number of Participants With Number of Lesions Detected - Stage 2
timeFrame: Within 5 minutes after injection
measure: Number of Participants With Quality of Lesion Visualization - Stage 1
timeFrame: Within 5 minutes after injection
measure: Number of Participants With Quality of Lesion Visualization - Stage 2
timeFrame: Within 5 minutes after injection
measure: Number of Participants With Quality of Border Delineation - Stage 1
timeFrame: Within 5 minutes after injection
measure: Number of Participants With Quality of Border Delineation - Stage 2
timeFrame: Within 5 minutes after injection
measure: Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
timeFrame: Within 5 minutes after injection
measure: Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
timeFrame: Within 5 minutes after injection
measure: Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1
timeFrame: Within 5 minutes after injection
measure: Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2
timeFrame: Within 5 minutes after injection
measure: Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
timeFrame: Within 5 minutes after injection
measure: Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
timeFrame: Within 5 minutes after injection
measure: Number of Participants With Diagnostic Confidence - Stage 1
timeFrame: Within 5 minutes after injection
measure: Number of Participants With Diagnostic Confidence - Stage 2
timeFrame: Within 5 minutes after injection
measure: Management Based on Unenhanced Images - Stage 1
timeFrame: Within 5 minutes before injection
measure: Management Based on Unenhanced Images - Stage 2
timeFrame: Within 5 minutes before injection
measure: Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1
timeFrame: Within 5 minutes after injection
measure: Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2
timeFrame: Within 5 minutes after injection
measure: Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1
timeFrame: Within 5 minutes after injection
measure: Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2
timeFrame: Within 5 minutes after injection
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Chicago
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Akron
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Kiel
country: Germany
state: Schleswig-Holstein
city: Jena
country: Germany
state: Thüringen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: