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

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guerbet; Mallinckrodt

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)

• history of significant claustrophobia

• weighs less than 25 lbs (11 kgs)