Shots:
- The EU approval of Vueway for neonates, infants, and toddlers is a milestone for pediatric imaging as it allows high-quality MRI imaging at half the GBCA dose, supporting reduced gadolinium exposure in vulnerable young patients
- Vueway’s gadopiclenol demonstrates safety and diagnostic performance by offering high stability, low dissociation risk, and 2.5–4× greater relaxivity than other macrocyclic GBCAs, enabling effective imaging while adhering to the ALARA principle
- PharmaShots welcomes Alberto Spinazzi, Chief Medical and Regulatory Officer at Bracco Group, for sharing expert insights on how Vueway’s expanded use can enhance pediatric radiology workflows, improve diagnostic confidence, and minimize gadolinium exposure
Saurabh: The expanded EU approval to extend Vueway’s use to patients from birth to under 2 years is being seen as a major milestone. What does this decision represent for paediatric diagnostic imaging in Europe?
Alberto: For healthcare professionals, this European Union (EU) approval provides peace of mind that imaging decisions are grounded in rigorous regulatory review and clinical evidence. Importantly, thanks to the high potency and contrast-enhancement efficacy of Vueway, this novel agent has been approved at a dose that is exactly half of that of the other gadolinium-based contrast agents (GBCAs) of the same class currently available in the EU. Therefore, the extension of the approved use of Vueway to neonates, infants and toddlers represents a concrete possibility to reduce exposure to gadolinium when a contrast-enhanced MR procedure is needed in young children.
Saurabh: Why is it so important to reduce exposure to gadolinium in young children?
Alberto: Reducing exposure is important for all medicines and at all ages, to possibly improve their tolerability and general safety by reducing the rate of predictable, dose-dependent adverse reactions.[1] When considering exposure to GBCAs, there is also concern about the dose-dependent, long-lasting retention of gadolinium in brain and body tissues of patients.[2] Even if the potential long-term effects of retained gadolinium are still unknown [3], significant concerns are about the use of GBCAs in neonates and infants, whose immature kidney function may lead to prolonged GBCA clearance, and in young paediatric patients in general, whose brains and body tissues are still maturing.[4]
Saurabh: What makes Vueway well suited for use in neonates, infants and toddlers?
Alberto: The active ingredient of Vueway, gadopiclenol, is characterized by a cage-like, macrocyclic structure, which provides high stability and kinetic inertness, meaning it is highly resistant to dissociation of gadolinium from the molecule and release of the metal in brain and body tissues.[5] Moreover, its relaxivity, i.e., its ability to enhance contrast enhancement on the MR images, is 2.5-4 times higher than that of the other approved macrocyclic GBCAs. This allows for obtaining adequate diagnostic efficacy at a dose that is exactly half that approved for the other macrocyclic GBCAs.[6] In other words, Vueway addresses the biggest need in modern MRI: adequate diagnostic performance using the minimum GBCA dose necessary, in adherence to the ALARA (As Low As Reasonably Achievable) principle.[7] This is important for all patients that need a contrast-enhanced MRI, but particularly in very young paediatric patients.[8]
Saurabh: What impact could this expanded indication have on real-world paediatric radiology workflows, particularly in tertiary care and neonatal intensive care settings?
Alberto: As specialized hubs, tertiary centers often handle the most challenging clinical scenarios. A higher-relaxivity agent like Vueway can improve the morphologic and morphometric assessment of neoplastic masses, also providing better delineation of lesion borders, which is essential for surgical planning and treatment monitoring in advanced oncology. Moreover, in real-world settings, lower-dose imaging also offers important benefits for children who may require multiple MRI exams over the course of their lives. Having an option that supports diagnostic confidence while minimizing exposure helps clinicians make thoughtful, efficient decisions based on risk-benefit consideration about the different options in front of them.
Saurabh: Finally, what key message would you like to share with paediatric radiologists and healthcare providers as they consider integrating Vueway into imaging protocols for their youngest patients?
Alberto: It is important that paediatric radiologists and healthcare providers always make a thorough assessment of the risk-benefit ratio of the approved GBCAs when selecting the one to use in their youngest patients. Vueway has demonstrated safe and effective use in very young children, and the extension of its approved indications to neonates, infants and toddlers confirms its safety and efficacy across all paediatric age groups. This recognition underscores the potential role of Vueway in helping reduce unnecessary gadolinium exposure while supporting responsible, high-quality imaging for highly vulnerable patients.
About the Author:
Alberto Spinazzi
Alberto Spinazzi serves as Chief Medical & Regulatory Officer at Bracco Group and Division Head reporting directly to the President and CEO of the Global Imaging Business Unit. In this role, he is responsible for defining and executing the overall strategic direction of Bracco’s global clinical, medical, and regulatory programs.
Dr. Spinazzi oversees the design and execution of clinical development initiatives, regulatory strategy, medical education and scientific communications, medical information, post-marketing surveillance operations, and worldwide support to sales operations.
References:
[1] Iasella CJ, Johnson HJ, Dunn MA. Adverse Drug Reactions: Type A (Intrinsic) or Type B (Idiosyncratic). Clin Liver Dis 2017; 21:73-87
[2] Starekova J, Pirasteh A, Reeder SB. Update on Gadolinium-Based Contrast Agent Safety, From the AJR Special Series on Contrast Media. AJR Am J Roentgenol 2024; 223(3): e2330036
[3] van der Molen AJ, Quattrocchi CC, Mallio CA, Dekkers IA; European Society of Magnetic Resonance in Medicine, Biology Gadolinium Research, Educational Committee (ESMRMB-GREC). Ten years of gadolinium retention and deposition: ESMRMB-GREC looks backward and forward. Eur Radiol. 2024; 34: 600-611
[4] Ouyang M, Bao L. Gadolinium Contrast Agent Deposition in Children. J Magn Reson Imaging 2025; 61:70-82
[5] Port M. The Discovery of Gadopiclenol: An Example of Rational Drug Design? Invest Radiol 2025; 60: 809-812
[6] Hao J, Pitrou C, Bourrinet P. A Comprehensive Overview of the Efficacy and Safety of Gadopiclenol: A New Contrast Agent for MRI of the CNS and Body. Invest Radiol 2024; 59: 124-130
[7] Dillman, J.R., Davenport, M.S. Gadolinium retention — 5 years later…. Pediatr Radiol 2020; 50: 166–167
[8] Sreedher G. Gadopiclenol for Pediatric Brain MRI: Efficacy at Half the Dose of Conventional Gadolinium-Based Contrast Agents. AJR Am J Roentgenol 2025; 225: e2533498.
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