Pharmacokinetics and Safety of the MRI Contrast Agent Gadoversetamide Injection (Optimark) in Healthy Pediatric Subjects

RATIONAL AND OBJECTIVE:This clinical trial examined the pharmacokinetics of gadoversetamide, a magnetic resonance imaging contrast agent, in normal pediatric subjects. MATERIALS AND METHODS:Seventeen healthy pediatric subjects received a single intravenous injection of gadoversetamide (0.1 mmol/kg,...

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Bibliographic Details
Published in:	Investigative radiology Vol. 39; no. 6; pp. 334 - 339
Main Authors:	Baker, James F, Kratz, Linda C, Stevens, Gary R, Wible, James H
Format:	Journal Article
Language:	English
Published:	United States Lippincott Williams & Wilkins, Inc 01-06-2004
Subjects:	Adolescent Age Factors Child Child, Preschool Contrast Media - administration & dosage Contrast Media - pharmacokinetics Humans Infant Injections, Intravenous Magnetic Resonance Imaging Organometallic Compounds - administration & dosage Organometallic Compounds - pharmacokinetics Safety
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Summary:	RATIONAL AND OBJECTIVE:This clinical trial examined the pharmacokinetics of gadoversetamide, a magnetic resonance imaging contrast agent, in normal pediatric subjects. MATERIALS AND METHODS:Seventeen healthy pediatric subjects received a single intravenous injection of gadoversetamide (0.1 mmol/kg, 0.2 mL/kg). Sixteen subjects that were evaluable for pharmacokinetic analysis fell into 2 stratified age groups2 years to <5 years and 5 years to <18 years of age. Serum samples were analyzed for total gadolinium as a measure of gadoversetamide concentration. RESULTS:Statistical analysis demonstrated significant (P < 0.05) age-related trends in the mean elimination half-life (t½) of gadolinium with the older group having a slightly longer t½ (1.39 hours) than the younger group (1.19 hours). No age-related changes occurred in volume of distribution or total body clearance, when normalized to body weight or body surface area. CONCLUSIONS:Based on this preliminary pharmacokinetic assessment, no adjustment from the approved adult gadoversetamide dose of 0.1 mmol/kg should be necessary for children aged 2 or older.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0020-9996 1536-0210
DOI:	10.1097/01.rli.0000124455.11402.52