Pediatric Trial Meets Endpoints for Low-Dose Contrast Agent
Bayer has presented the first results from QUANTI Pediatric, the company’s clinical study evaluating its investigational MRI contrast agent gadoquatrane in patients from birth to under 18 years of age. The data, presented as late-breaking clinical trial results at RSNA 2025, add to the overall safety and efficacy profile within Bayer’s QUANTI development program.
QUANTI Pediatric assessed gadoquatrane at a dose of 0.04 mmol Gd/kg, representing a 60% reduction compared with macrocyclic gadolinium-based contrast agents (GBCAs) typically dosed at 0.1 mmol Gd/kg. The study met its primary and secondary endpoints, showing pharmacokinetics in children similar to those observed in adults.
According to Bayer, these findings support the potential use of gadoquatrane as a low-dose contrast agent option for pediatric MRI exams.
Clinical Context and Need for Reduced-Dose MRI Contrast
“Contrast-enhanced MRI is increasingly used to assist in diagnosis and monitoring of certain conditions, 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 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.”
An estimated 1.5 million contrast-enhanced MRI exams are performed in children worldwide each year, with annual volume rising by 5%.
Regulatory Submissions Based on QUANTI Data
Gadoquatrane is part of Bayer’s pivotal QUANTI clinical program, which includes two Phase III studies in adults—QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions)—and the QUANTI Pediatric trial. Across these trials, 808 patients, including 93 children, were enrolled in 15 countries.
Based on favorable results, Bayer has submitted applications for marketing authorization of gadoquatrane in major global regions, including the U.S., EU, Japan, and China, with additional submissions expected.
“The QUANTI Pediatric results highlight gadoquatrane's potential as a low-dose MRI contrast agent for children,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer’s Pharmaceuticals Division. “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.”
Study Findings and Safety Profile
QUANTI Pediatric was a multicenter, prospective, open-label study evaluating pharmacokinetics, safety, tolerability, and diagnostic performance. According to Bayer, gadoquatrane improved visualization and key imaging parameters compared with pre-contrast MRI scans. No new safety signals were observed, and the safety profile aligned with previous findings in adults and with other macrocyclic GBCAs.
If approved, gadoquatrane would represent the lowest-dose macrocyclic GBCA available in the respective markets.
Source: Bayer
