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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Central Nervous System Pathology | Drug: Multihance | Phase 1 |
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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Drug: Multihance
- Assess the blood PK of Multihance in patients from 2 to 5 years of age [ Time Frame: up to 24 hours post dose ]
- Evaluate the safety of Multihance in patients from 2 to 5 years of age [ Time Frame: through 72 hours post dose ]

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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

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
Poland | |
Krakow, Poland |
Study Director: | Gianpaolo Pirovano, M. D. | Bracco Diagnostics, Inc |
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 |