Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 6 |
| Updated: | 11/8/2018 |
| Start Date: | April 2016 |
| End Date: | April 2021 |
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.
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.
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.
We found this trial at
1
site
757 Westwood Plaza
Los Angeles, California 90024
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Paul Finn, MD
Phone: 310-267-8745
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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