Bayer, a global leader in radiology, has unveiled positive results from its QUANTI Pediatric study, further supporting the safety and effectiveness of its investigational low-dose MRI gadolinium-based contrast agent (GBCA), gadoquatrane. 

The study, presented as late-breaking clinical trial data at the Radiological Society of North America (RSNA) annual congress, tested gadoquatrane in children with known or suspected disease undergoing contrast-enhanced MRI. The pediatric dose was 0.04 mmol Gd/kg, a 60% reduction compared to standard macrocyclic GBCAs, yet it met all primary and secondary endpoints assessing pharmacokinetics and safety. 

Researchers observed similar pharmacokinetic behavior in children and adults, suggesting diagnostic performance is consistent across age groups. 

“Contrast-enhanced MRI is increasingly used to assist in diagnosis and monitoring of certain conditions, from newborns to adulthood,” said Talissa Altes, Professor and Chair of Radiology at the University of Missouri, USA. 

“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 as well as various neurological diseases such as multiple sclerosis in children. 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.” 

Bayer’s QUANTI Pediatric study is part of its broader QUANTI clinical program, which includes two multinational Phase III studies in adults. Applications for global marketing authorization have been submitted in the U.S., EU, Japan, and China, with additional markets expected in the coming months. If approved, gadoquatrane would become the lowest-dose macrocyclic GBCA available in these regions. 

“Contrast-enhanced MRI serves as a crucial tool for disease detection and the ongoing condition management, including in children, and Bayer is committed to driving innovation in this important area,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer’s Pharmaceuticals Division. 

“The QUANTI Pediatric results highlight gadoquatrane's potential as a low-dose MRI contrast agent for children. 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. We look forward to ongoing collaborations with regulatory authorities around the world to make gadoquatrane accessible to patients and their healthcare providers as swiftly as possible.” 

QUANTI Pediatric was a multicenter, prospective, open-label study evaluating pharmacokinetics, safety, and tolerability in children from birth to under 18 years old. Results showed that gadoquatrane improved visualization and other key parameters compared to pre-contrast MRI scans, while the safety profile remained consistent with prior findings. 

The larger QUANTI program included 808 patients across 15 countries, including 93 children, and demonstrated effective lesion detection at a 60% lower gadolinium dose compared to conventional macrocyclic GBCAs. No new safety signals were observed. 

Globally, 1.5 million contrast-enhanced MRIs are performed in children each year, a number rising by 5% annually, highlighting the growing need for safer, low-dose imaging options.