Results from the PROMISE trial, which compared the safety and efficacy of a new gadolinium-based contrast agent with half the dose of gadolinium to that of standard agents, have reinforced experts’ confidence in the product.
The PROMISE trial did a side-by-side comparison of 0.05 mmol/kg gadopiclenol and 0.1 mmol/kg gadobutrol (Gadavist) when used during various contrast-enhanced MRI exams. The randomized, double-blinded phase 3 study, which took place at 33 centers across 11 different countries, revealed gadopiclenol to be noninferior to gadobutrol for all qualitative visualization parameters as rated by all blinded readers involved in the trial.
The majority of readers expressed no preference for either agent, and adverse events did not differ between the two in frequency, intensity, type, or association with GBCA injection, according to the trial’s results.
In September of 2022, the new GBCA was approved by the U.S. FDA for use in adults and children age 2 years and older during MRI exams of the central nervous system and body. At half the dose of other GBCAs, the American College of Radiology labeled gadopiclenol as a group 2 agent relative to its risk of triggering nephrogenic systemic fibrosis in patients following its administration. The college concluded that exposure to the agent represents risks that are “sufficiently low or possibly nonexistent.”
Gadopiclenol is independently commercialized by both Bracco Diagnostics (as VUEWAY) and Guerbet (as Elucirem), as the companies collaborated on its development.
In a prepared statement, Vice-Chairman and CEO of Bracco Imaging Fulvio Renoldi Bracco commented on the study’s publication, noting that prior to gadopiclenol, most GBCAs were indicated for the brain, spine or central nervous system but had “narrow” indications for the rest of the body.
"The publication of this data reinforces VUEWAY injection as a boundary-pushing and novel MRI contrast agent across the central nervous system (the brain, spine, and surrounding tissues) and body (the head and neck, thorax, abdomen, pelvis, and musculoskeletal system),” Renoldi Bracco said.
The trial’s results were published July 18 in Radiology.
Learn more about the GBCA below:
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.