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A Pharmacokinetics Study of MultiHance in Pediatric Patients

This study has been completed.
Information provided by:
Bracco Diagnostics, Inc Identifier:
First received: December 13, 2006
Last updated: January 10, 2008
Last verified: January 2008
Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults

Condition Intervention Phase
Central Nervous System Pathology Drug: Multihance Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Assess the blood PK of Multihance in patients from 2 to 5 years of age [ Time Frame: up to 24 hours post dose ]

Secondary Outcome Measures:
  • Evaluate the safety of Multihance in patients from 2 to 5 years of age [ Time Frame: through 72 hours post dose ]

Enrollment: 15
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Multihance
    0.5M administered as a single injection

Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00411931

Krakow, Poland
Sponsors and Collaborators
Bracco Diagnostics, Inc
Study Director: Gianpaolo Pirovano, M. D. Bracco Diagnostics, Inc
  More Information

Responsible Party: Gianpaolo Pirovano, MD, Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc. Identifier: NCT00411931     History of Changes
Other Study ID Numbers: MH 119
Study First Received: December 13, 2006
Last Updated: January 10, 2008 processed this record on September 21, 2017