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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. Read our disclaimer for details. Identifier: NCT02752191
Recruitment Status : Unknown
Verified March 2020 by Paul Finn, University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : April 26, 2016
Last Update Posted : March 30, 2020
Information provided by (Responsible Party):
Paul Finn, University of California, Los Angeles

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 molecules that quickly cross the capillary wall and access the interstitial space, a process which diminishes the signal contrast between blood vessels and surrounding tissue. Therefore, these types of GBCA are most useful for first-pass MR angiography, wherein the images are acquired quickly during the initial 15-30 seconds post-injection when the GBCA concentration is much higher in the arteries than in the interstitial space. For young children with complex CHD, the stringent requirements for high spatial resolution, and the need for cardiac gating and good blood-myocardium contrast in order to provide detailed evaluation of intracardiac structures are not compatible with conventional GBCA-based first-pass MR angiography. Even with Ablavar® (gadofosveset trisodium), an FDA approved GBCA with longer intravascular half-life than other GBCAs, cardiac-gated Ablavar®-enhanced MRI may be insufficient for young children with CHD based on our institutional experience and on data from the literature; there remains diminished blood-tissue contrast during the high-resolution cardiac-gated MRI. Furthermore, there have been safety concerns regarding gadolinium deposition in brain tissues after repeated GBCA exposure as well as concerns of nephrogenic systemic fibrosis (NSF) associated with GBCA injection in young children < 2 years old who may have immature renal function. The long-term health consequences of these effects in the pediatric population are unclear. For the above reasons, we seek to study the diagnostic imaging effectiveness of Feraheme (Feraheme®), an FDA-approved drug for parenteral iron supplementation, as an MRI contrast agent in children with CHD. Although Feraheme® has been approved for the treatment of iron deficiency anemia secondary to renal disease, Feraheme® has been used as an off-label MRI contrast agent at select medical centers.

Condition or disease Intervention/treatment Phase
Pediatric Congenital Heart Disease Drug: ferumoxytol Drug: gadofosveset Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : April 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Ferumoxytol
Ferumoxytol, 4mg/kg of body weight, one time infusion of several minutes
Drug: ferumoxytol
ferumoxytol as an MRI contrast agent infused over several minutes
Other Name: Feraheme

Active Comparator: gadofosveset
gadofosveset, 0.03mmol/kg, one time bolus injection
Drug: gadofosveset
gadofosveset as an MRI contrast agent injected over several seconds
Other Name: Ablavar

Primary Outcome Measures :
  1. Composite image quality score among 7 anatomical structures. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Image quality score at individual anatomical sites. [ Time Frame: 5 years ]
    1. image quality score at the aortic root.
    2. image quality score at the main pulmonary artery.
    3. image quality score at the coronary arteries.
    4. image quality score a the out-flow tracts.
    5. image quality score at the valves.
    6. image quality score at the ventricular chambers.
    7. image quality at the atria.

  2. Incidence of adverse events [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02752191

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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         
Sponsors and Collaborators
Paul Finn
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Responsible Party: Paul Finn, Professor, University of California, Los Angeles Identifier: NCT02752191    
Other Study ID Numbers: 16-00016
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Keywords provided by Paul Finn, University of California, Los Angeles:
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Ferrosoferric Oxide
Parenteral Nutrition Solutions
Pharmaceutical Solutions