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Open-label multi-center study of magnetic resonance imaging (MRI) with 0.1 mmol/kg BW Gadovist (1.0 M) to assess pharmacokinetics, safety and tolerability in children

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-004153-22

Femme et Homme

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Extrait

The primary objective is to evaluate pharmacokinetic parameters of Gadovist 1.0 in plasma at the standard dose of 0.1 mmol/kg body weight in children of different age according to ICH E 11. To determine the pharmacokinetic parameters, blood samples need to be taken immediately prior to injection (baseline sample) and three times up to 8 hours post-injection.

Critère d'inclusion

  • Gadovist as diagnostic imaging agent is approved only for adult patients. Diseases usually representing indications for contrast-enhanced Magnetic Resonance Imaging (CE-MRI) are common also in a pediatric population. This study is a clinical routinely study in pediatric patients (male/ female) aged 2-17 years (3 age groups: 2-6, 7-11, and 12-17 years) who are scheduled to undergo Gd-enhanced MRI of brain, spine, liver and/or kidneys or Gd-enhanced MRA (single field of view)

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