A Clinical Investigation of the Pharmacokinetics and Safety of MultiHance in Patients From 2-5 Years of Age Undergoing A Clinical Indicated MRI of the CNS

Bracco Diagnostics, Inc0 sites15 target enrollmentSeptember 2006

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Central Nervous System Pathology
Sponsor: Bracco Diagnostics, Inc
Enrollment: 15
Primary Endpoint: Assess the blood PK of Multihance in patients from 2 to 5 years of age
Status: Completed
Last Updated: 18 years ago

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

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

December 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•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

•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