New MRI contrast agent shows similar safety in children, adults
Low-dose gadoquatrane maintains image quality while reducing gadolinium
- Gadoquatrane is a new MRI contrast agent that uses a much lower gadolinium dose.
- It may help reduce lifetime gadolinium exposure.
- Studies show similar safety and drug profiles in children and adults.
Gadoquatrane, a contrast agent Bayer is developing for MRI scans, showed similar safety and pharmacokinetic (PK) profiles — meaning how a drug moves into, through, and out of the body — in both children and adults.
That’s according to data from the Phase 3 QUANTI Pediatric study (NCT05915026), which evaluated the safety and pharmacological properties of gadoquatrane when used as a contrast agent in children undergoing MRI.
The results were presented at this year’s annual congress of the Radiological Society of North America, which recently took place in Chicago. Bayer has submitted marketing applications for gadoquatrane in the U.S., the European Union, Japan, and China.
Why a lower-dose MRI contrast agent may be important
MRI scans are widely used to help diagnose and monitor neurological diseases such as multiple sclerosis (MS). When paired with the contrast agent gadolinium, they can highlight areas of lesions with active inflammation. While gadolinium is generally safe, currently used agents may leave small deposits in certain organs, especially after repeated use.
Gadoquatrane is a low-dose MRI gadolinium-based contrast agent that can detect regions of disease-related features using much less gadolinium than existing gadolinium-based contrast agents. According to Bayer, it can make contrast-enhanced MRI scans safer.
“The QUANTI Pediatric results highlight gadoquatrane’s potential as a low-dose MRI contrast agent for children,” Konstanze Diefenbach, MD, head of radiology research & development at Bayer’s Pharmaceuticals Division, said in a company press release. “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.”
The QUANTI program included two Phase 3 studies in adults — QUANTI CNS (NCT05915702) and QUANTI OBR (NCT05915728) — along with the QUANTI Pediatric study. QUANTI CNS focused on the use of gadoquatrane for imaging of the brain and spinal cord, while QUANTI OBR evaluated imaging in other parts of the body.
“MRI is particularly valuable in pediatric care due to its non-invasive nature: it supports for example the diagnosis and follow-up of … various neurological diseases such as multiple sclerosis in children,” said Talissa Altes, MD, professor at the University of Missouri. “As MRI contrast agents commonly contain gadolinium, [gadoquatrane] 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.”
Pediatric trial shows similar safety and PK across age groups
QUANTI Pediatric enrolled 93 children and adolescents from 10 countries, most of whom were male (59.1%). Participants underwent contrast-enhanced MRI in any body region, with the brain being the most common site (62.4%). All participants received 0.04 millimoles of gadoquatrane per kilogram (mmol Gd/kg) of body weight, a 60% reduction compared to the established gadolinium dose used with existing contrast agents (0.1 mmol Gd/kg body weight).
Gadoquatrane showed similar PK behavior and safety profiles across all three pediatric age groups, and these data overlapped with PK results in adults. According to the researchers, this allows the “extrapolation of efficacy from adult to pediatric patients according to ICH guidance.”
Overall, 16 patients experienced adverse events, including three that were serious, and five considered related to gadoquatrane.
Across all QUANTI studies, the safety profile was generally consistent with earlier gadoquatrane data and with other gadolinium-based contrast agents, with no new safety signals reported.
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