Half-Dose MRI Contrast Approved for Neonates
The Food and Drug Administration (FDA) has approved an expanded indication for MRI contrast agent gadopiclenol in pediatric patients under two years of age, including term neonates. Gadopiclenol, which provides the highest relaxivity among all available gadolinium-based contrast agents (GBCAs), enables the use of a half-dose of gadolinium while maintaining equivalent diagnostic quality — a particularly significant advantage for the youngest pediatric population.
What Is Gadopiclenol?
Gadopiclenol is a macrocyclic MRI contrast agent initially approved by the FDA in 2022 for adults and older pediatric patients. Marketed as Elucirem (Guerbet) and Vueway (Bracco Diagnostics), its main advantage lies in superior relaxivity — the ability to shorten T1 relaxation times of tissues, generating greater contrast per unit of administered gadolinium.
At a dosage of 0.05 mmol/kg (half the standard 0.1 mmol/kg dose of other GBCAs), gadopiclenol demonstrated qualitative lesion visualization equivalent to full-dose gadobutrol in a 2023 multicenter phase 3 study. This means patients receive half the amount of gadolinium for the same diagnostic information.
Why Half-Dose Matters in Pediatrics
As Dr. Azam Eghbal, pediatric radiologist at Children’s Hospital of Orange County, explained: “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.”
The concern about gadolinium exposure in young children is particularly relevant for several reasons: the neonatal blood-brain barrier is less mature, kidneys are still developing, and many pediatric patients require multiple MRI exams throughout life for monitoring chronic conditions. For centers already investing in dedicated neonatal MRI technology, the availability of a half-dose contrast represents a significant complementary advancement.
Clinical Demand and Adoption
Bracco Diagnostics noted that over 3.5 million doses of Vueway have been utilized in the United States, indicating high demand for gadopiclenol. Dr. Jeffrey Miller, pediatric neuroradiologist and chief of radiology at Phoenix Children’s Hospital, emphasized that the expanded approval is particularly significant for children requiring serial imaging monitoring: “For practices caring for children who may require multiple MRIs over time, this represents a practical and clinically meaningful advancement.”
In radiology practice worldwide, where artificial intelligence is complementing diagnostic imaging, the combination of safer contrast agents with AI tools for protocol optimization may transform pediatric MRI practice, reducing both gadolinium exposure and examination time.
Outlook and Regulatory Context
The FDA approval reinforces the regulatory trend of prioritizing safety in vulnerable populations. For regulatory agencies worldwide, the American precedent paves the way for discussions about incorporating gadopiclenol into local pediatric protocols. The transition to half-dose contrast agents in pediatric MRI may become the new standard of care, combining enhanced safety with equivalent diagnostics — especially in patients facing years of imaging follow-up.
Source: Diagnostic Imaging