A Pharmacokinetics Study of MultiHance in Pediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Central Nervous System Pathology

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Multihance

0.5M administered as a single injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No