Safety and Efficacy of MultiHance in Pediatric Patients

A Phase III Multi-Center Open Label Study to Evaluate Safety and Efficacy of MultiHance at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients

The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.

Inclusion Criteria:

• Between 2 and 17 years of age
• Informed consent from parents
• Assent from patient where required
• Known or highly suspected disease of the CNS and referred for either cranial or spinal MRI examination

Exclusion Criteria:

• Contraindication to MRI
• Undergoing MRI in an emergency situation
• Known allergy to one or more of the ingredients in MultiHance
• Sickle cell anemia moderate to severe renal impairment
• Received another investigational compound within 30 days
• Pregnancy
• Lactating females
• Likely to undergo an invasive procedure within 72 hours of receiving MultiHance