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A Pharmacokinetics Study of MultiHance in Pediatric Patients
This study has been completed.
Sponsor:
Bracco Diagnostics, Inc
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00411931
First received: December 13, 2006
Last updated: January 10, 2008
Last verified: January 2008
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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:
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
Eligibility| 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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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
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
| 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 |
ClinicalTrials.gov processed this record on June 28, 2017