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

This study has been completed.
Sponsor:
Information provided by:
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT01092754
First received: March 15, 2010
Last updated: March 24, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Pathological Processes
 Procedure: MRI
Drug: Gadoversetamide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • Assess efficacy by analyzing the clinical diagnosis, degree of confidence in diagnosis and level of conspicuity of lesions. [ Time Frame: Immediately before and immediately after Optimark dosing ] [ Designated as safety issue: No ]
    Optimark is an MRI contrast. Efficacy measurements will be determined from images obtained without contrast (immediately before) and with contrast (immediately after).


Secondary Outcome Measures:
  • Assess the safety of Optimark by analyzing adverse events and changes in vital signs, electrocardiograms (ECGs), physical exams, and clinical laboratory results. [ Time Frame: through 24 hours post dose ] [ Designated as safety issue: Yes ]
  • Assess the blood and urine PK levels of Optimark [ Time Frame: through 10 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: May 2002
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Other Procedure: MRI
contrast enhanced MRI
Other Name: 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 Name: Gadoversetamide
B: Other Procedure: MRI
contrast enhanced MRI
Other Name: 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 Name: 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).

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092754

Locations
United States, Arkansas
Arkansas Childrens Hospital
Little Rock, Arkansas, United States, 72201
United States, California
Childrens Hospital and Health Center
San Diego, California, United States, 92101
United States, Florida
Miami Children's Hospital
Miami, Florida, United States, 33011
United States, Kansas
Children's Mercy Hospitals and clinics
Kansas City, Kansas, United States, 66101
United States, Louisiana
Louisiana State University Sciences Center- Shreveport
Shreveport, Louisiana, United States, 71101
United States, Michigan
Childrens Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Missouri
St. Louis Childrens Hospital
St. Louis, Missouri, United States, 63010
Cardinal Glennon Childrens Hospital
St. Louis, Missouri, United States, 63010
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45202
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44102
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19092
United States, Texas
Texas Childrens Hospital
Houston, Texas, United States, 77002
Sponsors and Collaborators
Mallinckrodt
Investigators
Study Chair: Eddie Darton, MD Mallinckrodt
  More Information

No publications provided

Responsible Party: Eddie Darton, Jr., M.D./Director, Global Drug Safety & PVG, Mallinckrodt Inc.
ClinicalTrials.gov Identifier: NCT01092754     History of Changes
Other Study ID Numbers: 1177-01-597
Study First Received: March 15, 2010
Last Updated: March 24, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mallinckrodt:
brain, spine, liver, MRI, Pediatric

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013