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
1 other identifier
interventional
100
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2002
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 15, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedAugust 1, 2017
July 1, 2017
1.6 years
March 15, 2010
July 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
A: Other
OTHERB: Other
OTHERInterventions
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 .
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guerbetlead
Study Sites (12)
Arkansas Childrens Hospital
Little Rock, Arkansas, 72201, United States
Childrens Hospital and Health Center
San Diego, California, 92101, United States
Miami Children's Hospital
Miami, Florida, 33011, United States
Children's Mercy Hospitals and clinics
Kansas City, Kansas, 66101, United States
Louisiana State University Sciences Center- Shreveport
Shreveport, Louisiana, 71101, United States
Childrens Hospital of Michigan
Detroit, Michigan, 48201, United States
Cardinal Glennon Childrens Hospital
St Louis, Missouri, 63010, United States
St. Louis Childrens Hospital
St Louis, Missouri, 63010, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45202, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44102, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19092, United States
Texas Childrens Hospital
Houston, Texas, 77002, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eddie Darton, MD
Mallinckrodt
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 15, 2010
First Posted
March 25, 2010
Study Start
May 1, 2002
Primary Completion
December 1, 2003
Study Completion
December 1, 2003
Last Updated
August 1, 2017
Record last verified: 2017-07