A Pharmacokinetics Study of MultiHance in Pediatric Patients

Bracco

Status and phase: Completed; Phase 1

Conditions: Central Nervous System Pathology

Treatments: Drug: Multihance

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411931

MH 119

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)