MRI Contrast Agent Gadopiclenol Gets Expanded FDA Approval for Children Under Two Years of Age
Previously approved by the FDA in 2022, the macrocyclic gadolinium-based MRI contrast agent gadopiclenol can now be utilized to detect lesions with abnormal vascularity in the central nervous system and other parts of the body for children under the age of two.
The Food and Drug Administration (FDA) has approved an expanded indication for the use of the MRI contrast agent gadopiclenol in pediatric patients (including term neonates) under two years of age.
Providing the highest relaxivity in comparison to other available gadolinium-based contrast agents (GBCAs), gadopiclenol enables the use of a half-dose of gadolinium to facilitate MRI detection of lesions of abnormal vascularity in the brain, spine, abdomen, pelvis and musculoskeletal system, according to Guerbet, the co-developer of gadopiclenol (Elucirem). Gadopiclenol is also available as Vueway (Bracco Diagnostics).
Previously approved by the FDA in adults and pediatric patients in 2022, gadopiclenol at 0.05 mmol/kg dosing offered qualitative visualization of lesions equivalent to that for .1 mmol/kg of gadobutrol on full-body MRI scans in a
Commenting on the expanded FDA approval of the injectable contrast agent for use in younger pediatric patients, Azam Eghbal, M.D., cited the lower dosing of gadolinium as a significant advantage for gadopiclenol in this patient population.
"Our pediatric patients are still developing and often vulnerable and we want to consider that with everything we do. 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,” noted Dr. Eghbal, a pediatric radiologist at the Children’s Hospital of Orange County in Orange, Calif.
Citing the high demand for gadopiclenol, Bracco Diagnostics noted that over 3.5 million doses of Vueway have been utilized in the United States. Jeffrey Miller, M.D., added that the expanded FDA approval is particularly significant for young children who require serial monitoring with imaging.
“For practices caring for children who may require multiple MRIs over time, this represents a practical and clinically meaningful advancement,” pointed out Dr. Miller, a pediatric neuroradiologist and chief of radiology at Phoenix Children’s Hospital in Arizona.
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