Bayer Unveils Groundbreaking Pediatric Data for Investigational Low-Dose MRI Contrast Agent Gadoquatrane at RSNA 2025
Radiological Society of North America in Chicago, Bayer announced compelling new findings from the QUANTI Pediatric study—the first pediatric trial within its pivotal QUANTI clinical development program for gadoquatrane, an investigational macrocyclic gadolinium-based contrast agent (GBCA) designed for magnetic resonance imaging (MRI). These results represent a significant milestone in radiology, particularly for the care of younger patients, and underscore Bayer’s commitment to advancing safer, more effective imaging solutions across all age groups.
The QUANTI Pediatric study evaluated the pharmacokinetics and safety profile of gadoquatrane in children—from newborns to adolescents under 18 years of age—undergoing contrast-enhanced MRI for known or suspected disease. Administered at a dose of just 0.04 mmol Gd/kg body weight, gadoquatrane delivers a 60% reduction in gadolinium dose compared to standard macrocyclic GBCAs, which are typically dosed at 0.1 mmol Gd/kg. Notably, the trial successfully met both its primary and secondary endpoints, demonstrating a favorable safety profile and predictable pharmacokinetic behavior consistent with that observed in adult populations.
These findings are particularly significant given the growing reliance on MRI in pediatric diagnostics. Each year, an estimated 1.5 million contrast-enhanced MRIs are performed globally in children—a figure projected to rise by 5% annually as MRI becomes increasingly central to managing complex pediatric conditions, including oncologic, neurological, and inflammatory diseases. For young patients who may require multiple imaging procedures over their lifetime, minimizing cumulative gadolinium exposure has emerged as a key priority for clinicians, regulators, and families alike.
“Contrast-enhanced MRI is increasingly used to assist in the diagnosis and monitoring of a wide range of conditions, spanning from neonatal care through adolescence,” said Dr. Talissa Altes, Professor and Chair of Radiology at the University of Missouri, USA. “MRI is uniquely valuable in pediatric settings due to its non-invasive nature and lack of ionizing radiation. It plays a critical role in evaluating suspected tumors, congenital abnormalities, and neurological disorders such as pediatric-onset multiple sclerosis. For children who may undergo repeated scans throughout their lives, having a low-dose contrast agent like gadoquatrane could significantly reduce long-term gadolinium burden while maintaining high diagnostic quality.”
Gadolinium-based contrast agents have long been essential for enhancing the visibility of anatomical structures and pathological processes in MRI. However, concerns about gadolinium retention—especially in vulnerable populations like children—have prompted regulatory agencies and scientific societies to advocate for the use of the lowest effective dose. Macrocyclic GBCAs, such as gadoquatrane, are already considered the most stable class of agents due to their tight molecular structure, which minimizes gadolinium release. By further lowering the administered dose without compromising imaging performance, gadoquatrane aims to set a new standard for pediatric MRI safety.
The QUANTI Pediatric trial is part of Bayer’s broader QUANTI program, which also includes two multinational Phase III studies in adult populations. Together, these studies form the foundation of Bayer’s regulatory submissions for gadoquatrane, which have already been filed in key global markets including the United States, the European Union, Japan, and China, with additional filings expected in the coming months. If approved, gadoquatrane would become the lowest-dose macrocyclic GBCA available in these regions, offering a meaningful advancement in contrast-enhanced MRI.
“The QUANTI Pediatric results reinforce gadoquatrane’s potential to transform how we approach contrast-enhanced MRI in children,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer’s Pharmaceuticals Division. “This low-dose profile aligns with longstanding recommendations from health authorities and imaging societies, which emphasize using the minimal amount of contrast necessary to achieve diagnostic confidence. Our goal is not only to support accurate disease detection and monitoring but also to proactively address long-term safety considerations—especially for pediatric patients who represent a uniquely sensitive and growing patient population.”
The late-breaking presentation of QUANTI Pediatric data at RSNA 2025 underscores the scientific community’s interest in innovations that balance diagnostic efficacy with patient safety. RSNA, the world’s premier radiology conference, serves as a critical forum for sharing cutting-edge research, and the inclusion of this pediatric study highlights the increasing focus on tailored imaging approaches for younger patients.
Beyond safety, the study’s pharmacokinetic findings suggest that gadoquatrane behaves similarly in children as it does in adults, supporting the extrapolation of diagnostic performance data from adult trials to pediatric use. This consistency is vital for regulatory acceptance and clinical adoption, as it reduces the need for redundant efficacy trials in children while ensuring that the agent delivers reliable, high-quality imaging across age groups.
Bayer’s strategic investment in low-dose contrast technology reflects broader industry and regulatory trends. The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global bodies have issued guidance encouraging the development of agents that minimize gadolinium exposure without sacrificing diagnostic utility. Gadoquatrane’s 60% dose reduction directly responds to these calls, positioning it as a next-generation solution in an evolving clinical landscape.
Moreover, the potential approval of gadoquatrane could have far-reaching implications for healthcare systems worldwide. With pediatric MRI volumes rising steadily, a safer, lower-dose contrast agent may not only improve patient outcomes but also support more sustainable imaging practices—reducing concerns about long-term retention, enhancing parental and clinician confidence, and potentially lowering barriers to necessary follow-up imaging.
As Bayer continues its dialogue with regulatory agencies, the company remains focused on making gadoquatrane available to patients and healthcare providers as quickly as possible. The positive data from QUANTI Pediatric, combined with strong results from adult studies, lay a robust scientific foundation for that goal.
In an era where precision, safety, and patient-centered care are paramount, Bayer’s gadoquatrane represents a promising step forward—particularly for the youngest and most vulnerable MRI patients. With its innovative low-dose formulation and comprehensive clinical evidence, gadoquatrane could soon become an essential tool in modern pediatric radiology, helping clinicians see more clearly while safeguarding patients’ futures.
About QUANTI Pediatric and the Phase III development program QUANTI
QUANTI Pediatric was a multicenter, prospective, open-label study to evaluate the pharmacokinetics, safety and tolerability of gadoquatrane in children from birth to under 18 years old. The observed pharmacokinetic behaviour of gadoquatrane in children was similar to that in adults. The safety profile was in line with previous findings on gadoquatrane and other macrocyclic GBCAs. Additionally, the study assessed diagnostic performance in the pediatric population. Results show that gadoquatrane improved visualization and other key parameters when compared to pre-contrast MRI scans.
The pivotal QUANTI clinical development program for gadoquatrane consisted of two large multinational, randomized, prospective double-blind, crossover Phase III studies – QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions) – as well as the QUANTI Pediatric study. In total, 808 patients – including 93 children – in 15 countries participated in the program.
The results of the QUANTI studies show that gadoquatrane met the primary and secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection, while reducing the gadolinium dose by 60 percent compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. In all studies, the observed safety profile was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs. No new safety signals were observed. Further study data are planned to be presented at upcoming scientific meetings.
About gadoquatrane
Gadoquatrane is Bayer’s investigational extracellular macrocyclic contrast agent for contrast enhancement in MRI. This low-dose gadolinium-based contrast agent features a distinct tetrameric structure with high stability and high relaxivity.
About MRI
MRI is a non-invasive, radiation-free imaging method that provides detailed images of the body, helping to identify and distinguish potential abnormalities in organs and tissues. This supports physicians in answering critical medical questions related to the detection and monitoring of diseases. Approximately 12-18 million contrast-enhanced MRI scans are performed annually in the United States. Since their introduction in 1988, more than 800 million GBCA doses have been administered worldwide, with an estimated 63 million doses in 2023.
About Radiology at Bayer
Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer’s comprehensive offerings also include informatics solutions. In 2024, Bayer’s radiology products generated €2.1 billion in sales. Bayer continues to advance research and innovation in medical imaging, including the integration of AI.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses.
At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.
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