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

Pathological Processes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092754
• Other study ID #: 1177-01-597
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2010
• Last updated: July 31, 2017
• Start date: May 2002
• Est. completion date: December 2003

Study information

• Verified date: July 2017
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pathologic Processes
• Pathological Processes

Intervention

Procedure:
• MRI
contrast enhanced MRI
• 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 .

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Childrens Hospital of Michigan	Detroit	Michigan
United States	Texas Childrens Hospital	Houston	Texas
United States	Children's Mercy Hospitals and clinics	Kansas City	Kansas
United States	Arkansas Childrens Hospital	Little Rock	Arkansas
United States	Miami Children's Hospital	Miami	Florida
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Cardinal Glennon Childrens Hospital	Saint Louis	Missouri
United States	St. Louis Childrens Hospital	Saint Louis	Missouri
United States	Childrens Hospital and Health Center	San Diego	California
United States	Louisiana State University Sciences Center- Shreveport	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess efficacy by analyzing the clinical diagnosis, degree of confidence in diagnosis and level of conspicuity of lesions.	Optimark is an MRI contrast. Efficacy measurements will be determined from images obtained without contrast (immediately before) and with contrast (immediately after).	Immediately before and immediately after Optimark dosing
Secondary	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
Secondary	Assess the blood and urine PK levels of Optimark		through 10 hours post dose