Wellstar Health to assess Bracco's new MR contrast agent with half gadolinium dose
por John R. Fischer, Senior Reporter | February 21, 2023
MRI
Wellstar Health will trial VUEWAY (gadopiclenol), a new MR contrast agent that uses half the gadolinium dose of other contrast agents. (Photo courtesy of Bracco Imaging)
Wellstar Health System is among the first medical practices in the U.S. to trial the use of VUEWAY (gadopiclenol), an MR injection designed by Bracco Imaging to produce the same image quality with only half the dose of other gadolinium-based contrast agents (GBCA).
The higher sensitivity of VUEWAY allows for the dose to be lower, which, in turn, lowers the risk for gadolinium-induced toxicity.
The contrast agent was FDA approved in September to identify lesions in the central nervous system (brain, spine, and associated tissues) and the bodies (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) of adults and pediatric patients, ages two and up.
Fulvio Renoldi Bracco, vice-chairman and CEO of Bracco Imaging, says using half the dose also benefits the contrast agent supply chain, which experienced numerous disruptions in 2022, as it allows twice as many patients to be scanned with the same amount of source material.
"We're particularly excited about our innovations in contrast imaging because of the wide-reaching impact across disease categories with 30 million MR scans conducted annually, globally,” he said in a statement.
Does Gadolinium actually pose harm?
Considered the workhorse of MR contrast agents, the scientific community knew for over a decade that gadolinium posed risks to patients with renal insufficiencies before evidence emerged that it could accumulate in the brain.
While no adverse impacts have been found, the FDA now requires “black box” warnings about the heavy metal, and companies have looked into developing alternative contrast agents with less or no gadolinium.
Contrast agents, when used in MR exams, also increase the gadolinium levels in earth’s surface waters, as patients expel it in their urine within 24 hours. When exposed to UV light, it becomes toxic.
Japanese researchers emphasized this in a 2020 study after finding spikes in gadolinium throughout their city’s river waters.
Outshining other GBCAs
In two Phase III trials, VUEWAY was proved effective and safe in MR for the central nervous system (PICTURE trial) and the body (PROMISE trial).
When combining the study populations for both, more than 500 had MR scans with gadopiclenol that were compared to full-dose gadobutrol-based scans. Even with half dosage, blinded readers said gadopiclenol scans had comparable image quality.
The VUEWAY injection is manufactured in the U.S. by Liebel-Flarsheim Company LLC.
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The higher sensitivity of VUEWAY allows for the dose to be lower, which, in turn, lowers the risk for gadolinium-induced toxicity.
The contrast agent was FDA approved in September to identify lesions in the central nervous system (brain, spine, and associated tissues) and the bodies (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) of adults and pediatric patients, ages two and up.
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"We're particularly excited about our innovations in contrast imaging because of the wide-reaching impact across disease categories with 30 million MR scans conducted annually, globally,” he said in a statement.
Does Gadolinium actually pose harm?
Considered the workhorse of MR contrast agents, the scientific community knew for over a decade that gadolinium posed risks to patients with renal insufficiencies before evidence emerged that it could accumulate in the brain.
While no adverse impacts have been found, the FDA now requires “black box” warnings about the heavy metal, and companies have looked into developing alternative contrast agents with less or no gadolinium.
Contrast agents, when used in MR exams, also increase the gadolinium levels in earth’s surface waters, as patients expel it in their urine within 24 hours. When exposed to UV light, it becomes toxic.
Japanese researchers emphasized this in a 2020 study after finding spikes in gadolinium throughout their city’s river waters.
Outshining other GBCAs
In two Phase III trials, VUEWAY was proved effective and safe in MR for the central nervous system (PICTURE trial) and the body (PROMISE trial).
When combining the study populations for both, more than 500 had MR scans with gadopiclenol that were compared to full-dose gadobutrol-based scans. Even with half dosage, blinded readers said gadopiclenol scans had comparable image quality.
The VUEWAY injection is manufactured in the U.S. by Liebel-Flarsheim Company LLC.
Back to HCB News
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