A Pharmacokinetics Study of MultiHance in Pediatric Patients

January 10, 2008 updated by: Bracco Diagnostics, Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the blood PK of Multihance in patients from 2 to 5 years of age
Time Frame: up to 24 hours post dose
up to 24 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the safety of Multihance in patients from 2 to 5 years of age
Time Frame: through 72 hours post dose
through 72 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bracco Diagnostics, Inc

Investigators

  • Study Director: Gianpaolo Pirovano, M. D., Bracco Diagnostics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 13, 2006

First Submitted That Met QC Criteria

December 14, 2006

First Posted (Estimate)

December 15, 2006

Study Record Updates

Last Update Posted (Estimate)

January 11, 2008

Last Update Submitted That Met QC Criteria

January 10, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • MH 119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

3
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