A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children
Condition: Magnetic Resonance Imaging
Intervention: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention description: In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Contrast-enhanced MRI; MR angiography (MRA) Children 2-17 years

Summary:

      In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has
      already been approved for application in adults, will be investigated in children and
      adolescents. MRI is a modern and safe examination method without delivering radiation burden
      using magnetic fields to produce cross-sectional images of the human body. A special computer
      program then puts these images together and creates a two or three-dimensional image of the
      inner organs thus facilitating the detection and evaluation of pathological changes. In
      contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the
      examination which results in a stronger contrast in the examined area. Therefore,
      pathological changes can be more easily detected and evaluated compared to non-enhanced MRI.
      The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called
      Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine.
      Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e.
      in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney
      disease. Gadavist was examined in more than 2,900 adults within the framework of clinical
      studies during development and has been used after its marketing authorization in meanwhile
      more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only
      conducted with adults so far. Diseases requiring MRI examinations, however, often occur in
      children, too. Therefore, many contrast agents are already used on a regular basis in MRI
      examinations of children, some of these contrast agents being authorized already. Within the
      framework of this study the pharmacokinetic characteristics of Gadavist in children or
      adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in
      the body. In addition, safety and tolerability will be evaluated in order to demonstrate that
      Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents.
      Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body
      weight also for this population group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients (male/ female) of specific age groups (2-6 years, 7-11 years, 12-17 years)
             who are scheduled to undergo Gadolinium (Gd)-enhanced MRI of brain, spine, liver
             and/or kidneys or Gd-enhanced MRA (single field of view).

        Exclusion Criteria:

          -  Clinically unstable patients (e.g. intensive care unit)

          -  Renal insufficiency

          -  Patients undergoing a relevant change in chemotherapy </= 48 hours prior to and up to
             24 hours after the administration of Gadovist.