check_circleStudy Completed

Magnetic Resonance Imaging

Bayer Identifier:

91784

ClinicalTrials.gov Identifier:

NCT00937391

EudraCT Number:

2009-013081-17

EU CT Number:

Not Available
Contrast-enhanced MRI in children 2 months to <2 years

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

Key Participants Requirements

Sex

Both

Age

2 - 23 Months
  • - 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
  • - Clinical unstable participants (eg, intensive care unit)
    - Renal Insufficiency
    - Participants undergoing chemotherapy

Trial summary

Enrollment Goal
54
Trial Dates
January 2010 - September 2010
Phase
Phase 3
Could I Receive a placebo
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum der Friedrich-Schiller-Universität JenaJena, 07740, Germany
Terminated
Akron Children's HospitalAkron, 44308, United States
Completed
Mallinckrodt Institute of RadiologySt. Louis, 63110, United States
Terminated
University of California, San DiegoSan Diego, 92123, United States
Terminated
Children's Memorial HospitalChicago, 60614, United States
Terminated
University of Iowa Hospitals & ClinicsIowa City, 52242, United States
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Med. Fakultät der Martin-Luther-Universität Halle-WittenbergHalle, 06120, Germany
Completed
Klinikum der Christian-Albrechts-UniversitätKiel, 24105, Germany
Completed
Texas Children's HospitalHouston, 77030, United States
Completed
The Children's HospitalAurora, 80045, United States
Completed
Children's Mercy HospitalKansas City, 64108-9898, United States
Terminated
Penn State Milton S. Hershey Medical CenterHershey, 17033, United States

Primary Outcome

  • Number of participants with diagnostic adequacy - open-label Clinical Investigators (Per Protocol Set)
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Dose determined by Blinded Readers to be superior for diagnosis
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Paired-dose comparison of number of participants with dose superiority determined for 4 lesion visualization variables - Blinded Readers
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • PK analysis - total clearance (CL)
    date_rangeTime Frame:
    20 to 45 min and 4 to 8 h post injection
    enhanced_encryption
    Safety Issue:
    No
  • PK analysis - total clearance (CL)/body weight (BW)
    date_rangeTime Frame:
    20 to 45 min and 4 to 8 h post injection
    enhanced_encryption
    Safety Issue:
    No
  • PK analysis - volume of distribution at steady state (Vss)
    date_rangeTime Frame:
    20 to 45 min and 4 to 8 h post injection
    enhanced_encryption
    Safety Issue:
    No
  • PK analysis - volume of distribution at steady state (Vss) /body weight (BW)
    date_rangeTime Frame:
    20 to 45 min and 4 to 8 h post injection
    enhanced_encryption
    Safety Issue:
    No
  • PK analysis - Area under the drug concentration-time curve (AUC)
    date_rangeTime Frame:
    Samples taken 20 to 45 min and 4 to 8 h post injection. AUC calculated from time of injection to infinity
    enhanced_encryption
    Safety Issue:
    No
  • PK analysis - t 1/2
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with number of lesions detected - Stage 1
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with number of lesions detected - Stage 2
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with quality of lesion visualization - Stage 1
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with quality of lesion visualization - Stage 2
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with quality of border delineation - Stage 1
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with quality of border delineation - Stage 2
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Most frequent diagnostic findings with unenhanced images - Stage 1
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Most frequent diagnostic findings with unenhanced images - Stage 2
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Overall number of participants with change in diagnosis from unenhanced to combined images - Stage 1
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Overall number of participants with change in diagnosis from unenhanced to combined images - Stage 2
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with specific change in the diagnosis from unenhanced to combined images - Stage 1
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with specific change in the diagnosis from unenhanced to combined images - Stage 2
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with diagnostic confidence - Stage 1
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with diagnostic confidence - Stage 2
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Management based on unenhanced images - Stage 1
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Management based on unenhanced images - Stage 2
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Overall number of participants with change in management from unenhanced to combined images - Stage 1
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Overall number of participants with change in management from unenhanced to combined images - Stage 2
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with specific change in management from unenhanced to combined images - Stage 1
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with specific change in management from unenhanced to combined images - Stage 2
    date_rangeTime Frame:
    Within 5 minutes after injection
    enhanced_encryption
    Safety Issue:
    No

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
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe