A Pharmacokinetics Study of MultiHance in Pediatric Patients

Central Nervous System Pathology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411931
• Other study ID #: MH 119
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2006
• Last updated: January 10, 2008
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Central Nervous System Pathology

Intervention

Drug:
• Multihance
0.5M administered as a single injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the blood PK of Multihance in patients from 2 to 5 years of age		up to 24 hours post dose	No
Secondary	Evaluate the safety of Multihance in patients from 2 to 5 years of age		through 72 hours post dose	Yes