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A Pharmacokinetics Study of MultiHance in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT00411931
Recruitment Status : Completed
First Posted : December 15, 2006
Last Update Posted : January 11, 2008
Sponsor:
Information provided by:
Bracco Diagnostics, Inc

Study Description
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Brief Summary:
Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults

Condition or disease Intervention/treatment Phase
Central Nervous System Pathology Drug: Multihance Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Study Start Date : September 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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Arms and Interventions
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Intervention Details:
  • Drug: Multihance
    0.5M administered as a single injection

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

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411931


Locations
Poland
Krakow, Poland
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Gianpaolo Pirovano, M. D. Bracco Diagnostics, Inc
More Information
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Responsible Party: Gianpaolo Pirovano, MD, Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT00411931     History of Changes
Other Study ID Numbers: MH 119
First Posted: December 15, 2006    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: January 2008