Status:
COMPLETED
Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease
Lead Sponsor:
Paul Finn
Conditions:
Pediatric Congenital Heart Disease
Eligibility:
All Genders
1-6 years
Phase:
PHASE4
Brief Summary
The standard clinical cardiovascular MRI practice for children with CHD frequently involves the use of gadolinium-based contrast agents (GBCA) to enhance tissue contrast. Most GBCAs are small molecule...
Eligibility Criteria
Inclusion
- Male or female pediatric patients of all ethnicities (age newborn to 6 years) with known or suspected CHD with inconclusive echocardiographic exams and are referred for cardiovascular MRI for further evaluation of cardiac anatomy and function.
- Written informed consent obtained from subject's legal representative/guardian(s) and ability for subject to comply with the requirements of the study
Exclusion
- Standard clinical contraindications to MRI, including subjects with cochlear implants and implanted cardiac devices
- Subjects with past or current diagnosis of iron overload due to hereditary hemochromatosis or other causes (for subjects receiving Feraheme injection only).
- Subjects with known hypersensitivity or allergy to iron oxide particles.
- Subjects with renal insufficiency defined as estimated glomerular filtration rate (eGFR) \< 40 mL/min/1.73m2 (for subjects receiving Ablavar injection only).
- Subjects who are critically ill at the time of MRI and for whom the period of general anesthesia and separation from the critical care nursery or intensive care unit poses added risk as deemed by referring cardiologists, cardiac surgeons or the managing radiologist (for Part II only).
- Other medical conditions, in the judgment of the clinician investigator, that would increase the risks to the child related to participation in the study.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02752191
Start Date
April 1 2016
End Date
December 19 2018
Last Update
December 28 2022
Active Locations (1)
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1
UCLA Medical Center
Los Angeles, California, United States, 90095