Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease
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|ClinicalTrials.gov Identifier: NCT02752191|
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Congenital Heart Disease||Drug: ferumoxytol Drug: gadofosveset||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Active Comparator: Ferumoxytol
Ferumoxytol, 4mg/kg of body weight, one time infusion of several minutes
ferumoxytol as an MRI contrast agent infused over several minutes
Other Name: Feraheme
Active Comparator: gadofosveset
gadofosveset, 0.03mmol/kg, one time bolus injection
gadofosveset as an MRI contrast agent injected over several seconds
Other Name: Ablavar
- Composite image quality score among 7 anatomical structures. [ Time Frame: 5 years ]
- Image quality score at individual anatomical sites. [ Time Frame: 5 years ]
- image quality score at the aortic root.
- image quality score at the main pulmonary artery.
- image quality score at the coronary arteries.
- image quality score a the out-flow tracts.
- image quality score at the valves.
- image quality score at the ventricular chambers.
- image quality at the atria.
- Incidence of adverse events [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752191
|United States, California|
|UCLA Medical Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Maryann Burns, RT 310-267-8745|
|Principal Investigator: Paul Finn, MD|