A Pharmacokinetics Study of MultiHance in Pediatric Patients

This study has been completed.

Sponsor:

Information provided by:

Bracco Diagnostics, Inc

ClinicalTrials.gov Identifier:

NCT00411931

First received: December 13, 2006

Last updated: January 10, 2008

Last verified: January 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

December 13, 2006

Last Updated Date

January 10, 2008

Start Date ^ICMJE

September 2006

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assess the blood PK of Multihance in patients from 2 to 5 years of age [ Time Frame: up to 24 hours post dose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Assess the blood PK of Multihance in patients from 2 to 5 years of age

Change History

Complete list of historical versions of study NCT00411931 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate the safety of Multihance in patients from 2 to 5 years of age [ Time Frame: through 72 hours post dose ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Evaluate the safety of Multihance in patients from 2 to 5 years of age

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Pharmacokinetics Study of MultiHance in Pediatric Patients

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Central Nervous System Pathology

Intervention ^ICMJE

Drug: Multihance

0.5M administered as a single injection

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 5 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT00411931

Other Study ID Numbers ^ICMJE

MH 119

Has Data Monitoring Committee

Not Provided

Responsible Party

Gianpaolo Pirovano, MD, Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc.

Study Sponsor ^ICMJE

Bracco Diagnostics, Inc

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Gianpaolo Pirovano, M. D.

Bracco Diagnostics, Inc

Information Provided By

Bracco Diagnostics, Inc

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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