Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients
NCT ID: NCT01092754
Last Updated: 2017-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2002-05-31
2003-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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A: Other
MRI
contrast enhanced MRI
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 .
B: Other
MRI
contrast enhanced MRI
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 .
Interventions
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MRI
contrast enhanced MRI
MRI
contrast enhanced MRI
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
2 Years
18 Years
ALL
No
Sponsors
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Guerbet
INDUSTRY
Responsible Party
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Mallinckrodt Inc.
Principal Investigators
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Eddie Darton, MD
Role: STUDY_CHAIR
Mallinckrodt
Locations
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Arkansas Childrens Hospital
Little Rock, Arkansas, United States
Childrens Hospital and Health Center
San Diego, California, United States
Miami Children's Hospital
Miami, Florida, United States
Children's Mercy Hospitals and clinics
Kansas City, Kansas, United States
Louisiana State University Sciences Center- Shreveport
Shreveport, Louisiana, United States
Childrens Hospital of Michigan
Detroit, Michigan, United States
Cardinal Glennon Childrens Hospital
St Louis, Missouri, United States
St. Louis Childrens Hospital
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Childrens Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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1177-01-597
Identifier Type: -
Identifier Source: org_study_id
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