Bayer’s MRI contrast agent effective with 60% less gadolinium: Data
Use of gadoquatrane shows similar quality on MRI, may make MS scans safer
Gadoquatrane, a contrast agent Bayer is developing for use in MRI scans, is able to detect regions of damage and other disease-related features while using 60% less gadolinium — a chemical element used to enhance an MRI — compared with existing gadolinium-based contrast agents.
That’s according to new data from QUANTI, a Phase 3 clinical testing program focused on the use of gadoquatrane in contrast MRIs.
MRI scans play an important role in diagnosing diseases like multiple sclerosis (MS), and are typically performed routinely, and repeatedly — as often as every few months to every few years — to monitor how such conditions are progressing and responding to treatment.
While the contrast agent gadolinium, which is used in MS to visualize lesions with active inflammation, is considered safe in most cases, currently used gadolinium-based contrast agents can form deposits in certain organs. By reducing the gadolinium dose needed for imaging, gadoquatrane could make contrast-enhanced MRI scans safer for patients.
“As a leader in radiology, we are committed to bringing forward innovations for the benefit of patients, including potential options to reduce the gadolinium dose,” Konstanze Diefenbach, MD, Bayer’s head of radiology research and development, said in a company press release.
Gadoquatrane has a unique structure that allows it to provide clear imaging with a lower dose of gadolinium, according to the company. This structure makes it effective in identifying and monitoring abnormalities in organs and tissues, supporting accurate diagnosis and treatment of disease.
QUANTI program tested contrast agent gadoquatrane in MRI scans
The QUANTI program testing gadoquatrane comprised three Phase 3 studies — QUANTI CNS (NCT05915702), QUANTI OBR (NCT05915728), and QUANTI Pediatric (NCT05915026) — involving more than 800 patients from 15 countries.
QUANTI CNS focused on the use of gadoquatrane for imaging problems in the brain and spinal cord, while QUANTI OBR imaged other body regions, such as the abdomen, pelvis, heart, and blood vessels. As its name suggests, QUANTI Pediatric enrolled children and adolescents with known or suspected problems who were scheduled for an MRI.
Principal investigator Julian A. Luetkens, MD, of the University Hospital Bonn in Germany, called the program “a key step in exploring a reduced gadolinium dose for patients in clinical practice.”
According to Luetkens, “this is especially important for patients in need [of] repeat contrast-enhanced MRI examinations as well as vulnerable populations such as pediatric patients.”
Luetkens noted that “contrast-enhanced MRI is a key diagnostic tool and particularly important to help define the treatment pathway for patients potentially suffering from severe illnesses,” including conditions that affect the central nervous system, such as MS.
This is especially important for patients in need [of] repeat contrast-enhanced MRI examinations as well as vulnerable populations such as pediatric patients.
In the studies, gadoquatrane was given at a dose of 0.04 milimoles (a standard scientific measuring unit) of gadolinium per kg body weight. This is much lower than the standard 0.1 milimole gadolinium dose used with existing gadolinium-based contrast agents. Despite the lower dose, gadoquatrane produced similar results in detecting and visualizing abnormalities in MRI scans, the results showed.
Indeed, gadoquatrane met key goals for imaging quality and detecting lesions effectively, topline data showed.
The QUANTI Pediatric study also demonstrated that gadoquatrane has a similar pharmacokinetic profile — meaning how the drug moves into, through, and out of the body — in children and adults. The safety of the contrast agent was consistent across all age groups, including infants and young children, and no new safety issues were reported.
According to Diefenbach, Bayer is “looking forward to sharing the data with the scientific community.
“We are very pleased with the positive topline results of the QUANTI studies,” Diefenbach said.
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