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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Other | Other |
| |
| B: Other | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Procedure | contrast enhanced MRI |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eddie Darton, MD | Mallinckrodt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Childrens Hospital | Little Rock | Arkansas | 72201 | United States | ||
| Childrens Hospital and Health Center |
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| MRI | Procedure | contrast enhanced MRI |
|
|
| Gadoversetamide | Drug | 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 . |
|
| 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 |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C112666 | gadoversetamide |
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