Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease
Status:
Recruiting
Trial end date:
2021-04-01
Target enrollment:
Participant gender:
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.