Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02752191|
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : November 6, 2018
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|