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Completed

NCT Number: NCT00411931

A Pharmacokinetics Study of MultiHance in Pediatric Patients

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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Key information

Conditions

Central Nervous System Pathology

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Krakow, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multihance

Drug

0.5M administered as a single injection

Primary outcomes

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

    Time frame: up to 24 hours post dose

Secondary outcomes

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

    Time frame: through 72 hours post dose

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 15, 2006
Registry last updated
Jan 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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