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
Sponsor study identifier
interventional
100
1 country
12
Study Start
May 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2003
Actual (reported)Study Completion
December 2003
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2003
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2002
Date type not reportedThis date has not been verified as actual or estimated.
December 2003
Actual (reported)December 2003
Actual (reported)March 15, 2010
Actual (reported)March 25, 2010
Actual (reported)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
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
contrast enhanced MRI
contrast enhanced MRI
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
Eddie Darton, MD
Mallinckrodt
100 participants (actual enrollment reported by the registry).
First Submitted
March 15, 2010
First Posted
March 25, 2010
Study Start
May 2002
Date type not reportedThis date has not been verified as actual or estimated.
Mesenchymal Stem Cells for Frailty Syndrome
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 .
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Primary Completion
December 2003
Actual (reported)Study Completion
December 2003
Actual (reported)Last Updated
August 1, 2017
Record last verified: 2017-07
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Source: ClinicalTrials.gov.
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