Safety and Efficacy of MultiHance in Pediatric Patients

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bracco Diagnostics, Inc

Criteria

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