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

Guerbet12 sites in 1 country100 target enrollmentMay 2002

ConditionsPathological Processes

InterventionsMRI Gadoversetamide

DrugsGadoversetamide

Overview

Phase: Phase 4
Intervention: MRI
Conditions: Pathological Processes
Sponsor: Guerbet
Enrollment: 100
Locations: 12
Primary Endpoint: Assess efficacy by analyzing the clinical diagnosis, degree of confidence in diagnosis and level of conspicuity of lesions.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

May 2002

End Date

December 2003

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guerbet

Eligibility Criteria

Inclusion Criteria

•2 thru 18 years of age
•referred for MRI of the liver or CNS
•if female and of child-bearing potential, must have negative pregnancy test within 24 hours of study drug administration
•if applicable, agree to use medically accepted method of contraception throughout the study
•if necessary, patients entering the PK subgroup must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration
•understand the requirements of the study and provide written consent to participate, agree to abide by the study requirements

Exclusion Criteria

•previously entered into this study or a previous study using Optimark
•received investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period. (patients on a research protocol using an approved drug ar acceptable)
•medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance and all prescribed follow up
•known or suspected abnormal renal function for age or requiring dialysis during the study period
•pregnant or breastfeeding
•scheduled to undergo any contrast-enhanced examination within 7 days prior to baseline examination or during the course of this study period
•condition that is a contraindication to MRI (i.e., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, ferromagnetic aneurysm clip, ferromagnetic halo device, or other condition that would preclude patient proximity to a strong external magnetic field)
•experienced a previous hypersensitivity reaction to a gadolinium-based contrast agent
•recent history of hemolytic anemia, sickle cell anemia, or other hemoglobinopathy
•undergone a surgical procedure within one week prior to study admission or are planned to undergo a surgical procedure during study participation (central line placement is acceptable)

Arms & Interventions

A: Other

Intervention: MRI

A: Other

Intervention: Gadoversetamide

B: Other

Intervention: MRI

B: Other

Intervention: Gadoversetamide

Outcomes

Primary Outcomes

Assess efficacy by analyzing the clinical diagnosis, degree of confidence in diagnosis and level of conspicuity of lesions.

Time Frame: Immediately before and immediately after Optimark dosing

Optimark is an MRI contrast. Efficacy measurements will be determined from images obtained without contrast (immediately before) and with contrast (immediately after).

Secondary Outcomes

Assess the blood and urine PK levels of Optimark(through 10 hours post dose)
Assess the safety of Optimark by analyzing adverse events and changes in vital signs, electrocardiograms (ECGs), physical exams, and clinical laboratory results.(through 24 hours post dose)