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A Pharmacokinetics Study of MultiHance in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00411931
First received: December 13, 2006
Last updated: January 10, 2008
Last verified: January 2008
History of Changes
  Purpose

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: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the safety of Multihance in patients from 2 to 5 years of age [ Time Frame: through 72 hours post dose ] [ Designated as safety issue: Yes ]
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
  Eligibility
Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411931

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

No publications provided

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
Study First Received: December 13, 2006
Last Updated: January 10, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gadobenic acid
Gadolinium DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 25, 2015