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

Guerbet

Status and phase

Completed

Phase 4

Conditions

Pathological Processes

Treatments

Drug: Gadoversetamide

Procedure: MRI

Study type

Interventional

Funder types

Industry

Identifiers

NCT01092754

1177-01-597

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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)
history of significant claustrophobia
weighs less than 25 lbs (11 kgs)