Gadolinium Contrast Agent Approved for Supra-Aortic MRI Angiography

A gadolinium-based contrast agents (GBCA) indicated for use with magnetic resonance angiography (MRA) has been approved for evaluating supra-aortic or renal artery disease.

Gadavist, a product of Bayer (Leverkusen, Germany) was previously indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients (including term neonates) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system (CNS). It is also indicated for use with MRI to assess the presence and extent of malignant breast disease.

In MRI, visualization of normal and pathological tissue depends on variations in the radiofrequency (RF) signal intensity that occurs with differences in proton density, differences of spin-lattice (longitudinal) relaxation times (T1), and differences in the spin-spin (transverse) relaxation time (T2). When placed in a magnetic field, Gadavist shortens the T1 and T2 relaxation times, depending on the concentration in the tissue, the field strength of the MRI system, and the relative ratio of the longitudinal and transverse relaxation times.

“Until now, no contrast agents were FDA-approved for use with MRA of the supra-aortic arteries,” said Elias Melhem, MD, chair of the department of diagnostic radiology & nuclear medicine at the University of Maryland, lead investigator for the Gadavist-Enhanced MRA of the Supra-Aortic Vessels (GEMSAV) study. “With FDA's action, radiologists now have an approved MRA contrast agent to help visualize supra-aortic arteries in patients with known or suspected supra-aortic arterial disease, including conditions such as prior stroke or transient ischemic attack.”

GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired drug elimination of the drugs. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. The risk for NSF appears highest among patients with chronic, severe kidney disease or acute kidney injury (AKI).

Related Links:
Bayer