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Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Paul Finn, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02752191
First received: April 15, 2016
Last updated: April 22, 2016
Last verified: April 2016
  Purpose
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 Intervention Phase
Pediatric Congenital Heart Disease
Drug: ferumoxytol
Drug: gadofosveset
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

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

Secondary Outcome Measures:
  • 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.

  • Incidence of adverse events [ Time Frame: 5 years ]

Estimated Enrollment: 120
Study Start Date: April 2016
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02752191

Locations
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
  More Information

Responsible Party: Paul Finn, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02752191     History of Changes
Other Study ID Numbers: 16-00016
Study First Received: April 15, 2016
Last Updated: April 22, 2016

Keywords provided by University of California, Los Angeles:
ferumoxytol

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on April 28, 2017