A Pharmacokinetics Study of MultiHance in Pediatric Patients

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bracco Diagnostics, Inc

Criteria

Inclusion Criteria:

• Male or female between 2 and 5 years of age

• Obtained informed consent from patient's parent or guardian

• Obtain assent when applicable according to local law

• Known or suspected disease of the central nervous system (brain or spine)

• Referred for MRI of the brain or spine requiring an injection of an MR contrast agent

Exclusion Criteria:

• Contraindications to MR examination

• Undergoing MRI in an emergency situation

• Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals

• Sickle cell anemia

• Likely to undergo an invasive examination within 72 hours after administration of the investigational product