FDA approves expanded use of gadolinium-based imaging agent
A newer low-dose gadolinium-based contrast agent (GBCA) can now officially be used in infants and children under two years old.
It was announced on Friday that the U.S. Food and Drug Administration approved a label update for Elucirem (gadopiclenol) that expands the contrast agent’s indication for the youngest of pediatric patients, including term neonates. Gadopiclenol, which is the result of a collaboration between Guerbet and Bracco, is a macrocyclic high-relaxivity GBCA that contains less than half the amount of gadolinium that standard agents are formulated with.
The FDA first approved the GBCA for use in adults and children ages 2 and older in 2022; the European Medicine’s Agency followed suit in 2023. Since its approval, the agent has become popular among providers, especially those who treat patients requiring frequent contrast-enhanced MRI exams, as it can reduce the long-term risk of gadolinium retention.
"Our pediatric patients are still developing and often vulnerable and we want to consider that with everything we do,” Azam Eghbal, MD, medical director of pediatric radiology at Children's Hospital of Orange County, California, said in a Feb. 20 announcement from Guerbet. “One key asset of Elucirem is that, thanks to its higher relaxivity, we can get good image quality using only half the conventional gadolinium dose. That makes a real difference in terms of amount of gadolinium injected, especially for these young patients, without losing diagnostic accuracy."
The updated label follows recent research that tested the safety and efficacy of the agent in children. One of these studies, which compared gadopiclenol (0.05 mmol/kg dosing) and gadoterate meglumine (0.1 mmol/kg)—the standard of care GBCA in pediatric MRI—found that gadopiclenol provided the same quality imaging as the standard of care. What’s more, there were no adverse side effects reported with its use.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.