LiverMultiScan may lessen need for biopsy in assessing MASLD
Real-world study supports MRI tool's efficacy in diagnosing disease and its severity
Perspectum‘s MRI-based LiverMultiScan improves the diagnostic rate of metabolic dysfunction-associated steatotic liver disease (MASLD) — a form of fatty liver disease — reduces the need for a liver biopsy, and is more cost-effective than standard assessment methods alone in determining disease severity.
That’s according to data from RADIcAL-1 (NCT03289897), a real-world clinical trial that tested LiverMultiScan plus standard methods against standard methods alone in more than 800 adults with suspected MASLD in four European countries.
“These findings support the utility of multiparametric MRI biomarkers to diagnose and improve patient management all while avoiding the need for biopsy in many patients,” Rajarshi Banerjee, MD, PhD, CEO of Perspectum, said in a company press release. “The study showed Perspectum’s LiverMultiScan improves certainty of diagnosis to allow for timely treatment, lowers costs and helps clinicians and patients to manage symptoms and reduce the impact of the disease.”
Results were in the study “Utility and cost-effectiveness of LiverMultiScan for MASLD diagnosis: a real-world multi-national randomised clinical trial,” published in Nature Communications.
Liver biopsy is standard way of determining if fibrosis evident in liver
Fatty liver disease is a condition marked by excess fat in the liver. MASLD is the most common type of fatty liver disease, in which fat buildup is related to cardiometabolic risk factors such as obesity, high blood pressure, high cholesterol levels, and diabetes. Metabolic dysfunction-associated steatohepatitis, or MASH, is a severe form of MASLD marked by liver inflammation and scarring (fibrosis).
MASLD diagnosis typically involves blood tests to measure liver enzyme levels, which can indicate liver problems but are not specific to MASLD. Imaging tests, such as MRI, CT, and ultrasound, can help to detect the presence of fatty liver, but they can’t definitively determine how far the disease has advanced.
A liver biopsy is a standard method to assess MASLD severity. Still, it’s invasive and costly, and it increases the risk of pain, bleeding, and infections.
Cleared for use in both the U.S. and Europe, LiverMultiScan is a commercially available, noninvasive MRI scan intended to diagnose, monitor, and manage people with liver diseases, including MASLD and certain forms of hepatitis, or inflammation of the liver.
However, as “a new test, it is not yet widely established in clinical practice,” the researchers wrote on the trial page.
802 adults with suspected MASLD evaluated with or without LiverMultiScan
With this mind, Perspectum launched RADIcAL-1, a real-world trial to evaluate the utility and cost-effectiveness of adding LiverMultiScan to usual MALSD assessments, such as ultrasound and liver biopsies.
The study enrolled 802 adults, ages 18-75, with suspected MASLD across Germany, the Netherlands, Portugal, and the U.K. To be eligible, patients had to have either elevated liver enzymes, imaging data suggestive of fatty liver disease, or three or more cardiometabolic risk factors.
Participants were randomly assigned to standard care either with or without LiverMultiScan, and followed for up to one year.
Overall, a higher proportion of patients who underwent LiverMultiScan received a MALSD/MASH diagnosis compared with those on standard care alone (57% vs. 48%). Group differences reached statistical significance in Germany and the Netherlands.
With LiverMultiScan, the need for specialist consultations fell significantly by 9%, including 7% fewer hospital appointments and 7% fewer visits to general practitioners. Additionally, there were significantly fewer ultrasound procedures, by 29%, in the LiverMultiScan group.
MRI-based tool found no signs of MASH in people also given liver biopsy
Of the 20 patients in the LiverMultiScan group who underwent a liver biopsy due to suspected MASH, eight (40%) had MASH with fibrosis, while 10 (50%) did not. Among these, nine people (45%) had no signs of MASH with fibrosis using LiverMultiScan and could have avoided a liver biopsy.
Of the 23 patients in the standard care group who underwent a liver biopsy, 11 (48%) did not have MASH with fibrosis.
To measure cost-effectiveness, the researchers compared access to healthcare practitioners, patient assessments, and the number of patients diagnosed at the trial’s end.
The incremental cost-effectiveness ratio (ICER), which corresponded to the cost difference between LiverMultiScan and standard care divided by the difference in outcomes, was €5,067.77 (about $5,493 at current exchange rates) in favor of LiverMultiScan.
When adjusted for missed diagnosis, LiverMultiScan was deemed cost-effective, with an ICER of €4,929 (about $5,343) per quality-adjusted life year (QALY) gained. QALY measures disease burden that accounts for quality of life and the number of years lived. For example, one QALY equates to one year in perfect health.
“These results are important because they show that using the MRI scan is affordable and effective enough to be recommended as it can make diagnosing liver disease faster, more accurate, and less invasive,” the researchers wrote.
“In addition to being more patient friendly and faster, this study shows non-invasive pathways are more cost-effective than liver biopsy,” Banerjee said. “The evidence in the study may also provide policy makers and practitioners with a greater understanding of how scaling LiverMultiScan into standard of care can be a win-win for improving diagnosis and managing costs associated with care.”
Henry Chang, executive director of the Fatty Liver Foundation, added: “Diagnostic innovations that streamline clinical workflows while minimizing patient burden, are essential to advancing MASLD care.”
The study received funding from the European Union’s Horizon 2020 research and innovation program.
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