NCT01092754

Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients

An Open-Label, Multicenter, Phase 4 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark(R) in Pediatric Patients (2-11 & 12-18 Yrs) Referred for Contrast-Enhanced MRI

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to characterize the safety, efficacy and pharmacokinetic profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient population.

Detailed description

Pediatric patients referred for magnetic resonance imaging (MRI) of the liver or central nervous system (CNS) will be stratified by age to one of two groups (2 through 11 and 12 through 18 years of age).

Conditions

• Pathological Processes

Interventions

Type	Name	Description
PROCEDURE	MRI	contrast enhanced MRI
PROCEDURE	MRI	contrast enhanced MRI
DRUG	Gadoversetamide	Subjects will receive a single dose of Optimark(0.1 mmol/kg)as a bolus thru a peripheral IV line at 1-2 mL/sec followed by a saline flush during their medically necessary MRI .

Timeline

• Start date: 2002-05-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2010-03-25
• Last updated: 2017-08-01

Locations

12 sites across 1 country: United States