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

PHASE4CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 31, 2002

Primary Completion Date

December 31, 2003

Study Completion Date

December 31, 2003

Conditions
Pathological Processes
Interventions
PROCEDURE

MRI

contrast enhanced MRI

PROCEDURE

MRI

contrast enhanced MRI

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 .

Trial Locations (12)

19092

The Children's Hospital of Philadelphia, Philadelphia

33011

Miami Children's Hospital, Miami

44102

University Hospitals of Cleveland, Cleveland

45202

Cincinnati Children's Hospital Medical Center, Cincinnati

48201

Childrens Hospital of Michigan, Detroit

63010

Cardinal Glennon Childrens Hospital, St Louis

St. Louis Childrens Hospital, St Louis

66101

Children's Mercy Hospitals and clinics, Kansas City

71101

Louisiana State University Sciences Center- Shreveport, Shreveport

72201

Arkansas Childrens Hospital, Little Rock

77002

Texas Childrens Hospital, Houston

92101

Childrens Hospital and Health Center, San Diego

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Guerbet

INDUSTRY