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

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.

Study Overview

• Status: Completed
• Conditions: Pathological Processes
• Intervention / Treatment: Procedure: MRI; Drug: Gadoversetamide

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).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72201
      • Arkansas Childrens Hospital
  • California
    • San Diego, California, United States, 92101
      • Childrens Hospital and Health Center
  • Florida
    • Miami, Florida, United States, 33011
      • Miami Children's Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66101
      • Children's Mercy Hospitals and Clinics
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Louisiana State University Sciences Center- Shreveport
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Childrens Hospital of Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63010
      • Cardinal Glennon Childrens Hospital
    • Saint Louis, Missouri, United States, 63010
      • St. Louis Childrens Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45202
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44102
      • University Hospitals Of Cleveland
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19092
      • The Children's Hospital of Philadelphia
  • Texas
    • Houston, Texas, United States, 77002
      • Texas Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: A: Other	Procedure: MRI; contrast enhanced MRI; Other Names: gadoversetamide; 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 .
OTHER: B: Other	Procedure: MRI; contrast enhanced MRI; Other Names: gadoversetamide; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Assess the blood and urine PK levels of Optimark	through 10 hours post dose

Collaborators and Investigators

• Sponsor: Guerbet
• Investigators: Study Chair: Eddie Darton, MD, Mallinckrodt

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (ACTUAL): December 1, 2003
• Study Completion (ACTUAL): December 1, 2003

Study Registration Dates

• First Submitted: March 15, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (ESTIMATE): March 25, 2010

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: brain, spine, liver, MRI, Pediatric
• Additional Relevant MeSH Terms: Pathologic Processes
• Other Study ID Numbers: 1177-01-597