Bayer's Low-Dose MRI Contrast Agent Gadoquatrane Shows Promise in Pediatric Study
核心洞察
Bayer's investigational MRI contrast agent gadoquatrane met primary and secondary endpoints in the QUANTI Pediatric study, demonstrating similar pharmacokinetic behavior in children as observed in adults.
The study evaluated gadoquatrane at a 60% reduced gadolinium dose of 0.04 mmol Gd/kg body weight compared to standard macrocyclic contrast agents, potentially reducing lifetime gadolinium exposure in pediatric patients.
Based on positive results from the complete QUANTI program involving 808 patients across 15 countries, Bayer has submitted marketing authorization applications worldwide, including in the U.S., EU, Japan, and China.
Bayer announced positive results from its QUANTI Pediatric study of gadoquatrane, an investigational low-dose MRI contrast agent, at the Radiological Society of North America (搜索) (RSNA) annual congress in Chicago. The study met its primary and secondary endpoints while demonstrating a 60% dose reduction compared to standard macrocyclic gadolinium-based contrast agents (GBCAs).
Study Design and Results
QUANTI Pediatric was a multicenter, prospective, open-label study evaluating the pharmacokinetics, safety and tolerability of gadoquatrane in children from birth to under 18 years old. The study administered gadoquatrane at a gadolinium dose of 0.04 mmol Gd/kg body weight, representing a significant reduction from the standard 0.1 mmol Gd/kg body weight used with macrocyclic GBCAs (搜索).
The observed pharmacokinetic behavior of gadoquatrane in children was similar to that in adults, indicating that diagnostic performance demonstrated in adult populations can be applied to pediatric patients. The safety profile was consistent with previous findings on gadoquatrane and other macrocyclic GBCAs (搜索), with no new safety signals observed.
Results showed that gadoquatrane improved visualization and other key parameters when compared to pre-contrast MRI scans, meeting the study's diagnostic performance objectives in the pediatric population.
Comprehensive Development Program
The pediatric study forms part of Bayer's pivotal QUANTI clinical development program, which included two large multinational, randomized, prospective double-blind, crossover Phase III studies: QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions). In total, 808 patients—including 93 children—across 15 countries participated in the complete program.
The results of all QUANTI studies demonstrated that gadoquatrane met primary and secondary efficacy endpoints assessing visualization parameters and lesion detection while maintaining the 60% gadolinium dose reduction compared to standard macrocyclic GBCAs (搜索).
Clinical Significance for Pediatric Care
"Contrast-enhanced MRI is increasingly used to assist in the diagnosis and monitoring of certain conditions in children, from newborns to adulthood," said Talissa Altes, MD, Professor and Chair of Radiology at the University of Missouri. "MRI is particularly valuable in pediatric care due to its non-invasive nature: it supports for example the diagnosis and follow-up of potential tumors (搜索) as well as various neurological diseases (搜索) such as multiple sclerosis (搜索) in children."
Dr. Altes emphasized the importance of dose reduction for pediatric patients: "As MRI contrast agents commonly contain gadolinium, it can be especially relevant for patient groups that require multiple MRI exams over their lifetime, like pediatric patients, to have a low-dose contrast agent option to reduce lifetime exposure."
Regulatory Pathway and Market Potential
Based on the positive QUANTI data, including the pediatric study results, Bayer has submitted applications for marketing authorization of gadoquatrane in markets worldwide, including Japan, the United States, the European Union, and China, with additional markets to follow in the coming months.
If approved, gadoquatrane would become the lowest dose macrocyclic gadolinium-based contrast agent available in the respective markets. Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer's Pharmaceuticals Division, noted that "a low dose is also in line with health authorities and scientific bodies which advise using the lowest dose required to obtain the needed clinical information."
Technology and Market Context
Gadoquatrane is Bayer's investigational extracellular macrocyclic contrast agent featuring a distinct tetrameric structure with high stability and high relaxivity. The agent is designed for contrast enhancement in MRI, a non-invasive, radiation-free imaging method that provides detailed images of the body to help identify and distinguish potential abnormalities in organs and tissues.
Bayer's radiology portfolio generated €2.1 billion in sales in 2024, with the company continuing to advance research and innovation in medical imaging, including artificial intelligence integration. The company's comprehensive radiology offerings include contrast agents and devices for computed tomography (CT), X-ray, magnetic resonance imaging (MRI), and positron emission tomography (PET).