In the RADIcAL-1 trial, mpMRI with LiverMultiScan reduced liver biopsies, led to fewer specialist consultations, and improved MASLD diagnosis rates.
Rajarshi Banerjee, MD, PhD
Credit: Perspectum
Multiparametric magnetic resonance imaging (mpMRI) with LiverMultiScan is a cost-effective tool for identifying and managing patients with metabolic dysfunction-associated steatotic liver disease (MASLD), according to findings from the RADIcAL-1 trial.1
The trial compared the utility and cost-effectiveness of adding mpMRI to standard of care (SoC) versus SoC alone for MASLD risk stratification in more than 800 patients from Germany, the Netherlands, Portugal, and the UK and found the addition of mpMRI improved diagnosis rates, reduced the need for specialist consultations, and avoided unnecessary liver biopsies.1
“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 press release.2 “Specifically, 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.”
In RADIcAL-1, a cohort of 802 patients 18-75 years of age who were due to undergo evaluation for suspected MASLD were randomly assigned in a 1:1 ratio to one of 2 study arms: the SoC arm or the imaging arm.1
Investigators noted that care across centers was not homogenized in order to real-life clinical practice with variable treatment and management patterns depending on clinician discretion at each included site.1
The trial’s primary endpoint was cost-effectiveness and improvement in resource use using mpMRI.1
Costs from a health system payer perspective were sourced and multiplied by the frequency of use for each patient. For the purpose of analysis, an incremental cost-effectiveness ratio (ICER) ≤£10,000 (~€11,200) per quality-adjusted life year (QALY) gained was considered cost-effective.1
To quantify the types and frequency of health care resource use following randomization, participants completed a health care resource use questionnaire (HCRUQ) on outpatient investigations including blood tests, biopsies, medical imaging, and medical consultations at 2-, 6- and 12-months following inclusion into the trial. Investigators additionally assessed and compared the proportion of patients in each arm with a final diagnosis by the end of the trial follow-up period.1
An avoidable biopsy was defined as one that did not meet the criteria for MASH with fibrosis, defined as a MASLD activity score ≥ 4 and fibrosis ≥ 2. In the imaging arm, PDFF and cT1 were used to classify patients as either having a low (both PDFF < 10% and cT1 < 800 ms) or high (either PDFF ≥ 10% or cT1 ≥ 800 ms) MASH risk, and a cT1 value <875ms was used to stratify patients who could have avoided the procedure.1
Among the cohort (n = 802), 403 patients were randomized into the imaging arm and 399 were randomized into the SoC arm. Investigators noted patients in the SoC arm had significantly more specialist appointments with healthcare professionals and for patient assessments than those in the imaging arm (P = .015).1
At the end of the trial, 53% of the cohort had a final diagnosis. Despite having fewer patient appointments, the imaging arm had a significantly higher percentage of patients with a diagnosis compared with SoC (57% vs 48%; P = .0012).1
Biopsy results showed 8 patients (40%) had MASH with fibrosis, while 10 patients (50%) did not meet the histological criteria for this diagnosis and thus could have avoided having a biopsy. Of 10 patients who did not meet the histological criteria of having MASH with fibrosis, 9 had a cT1 ≤ 875 ms and therefore could have avoided biopsy using mpMRI.1
In the imaging arm, the additional costs due to the inclusion of MRI (€97,057.07; $105,850.61 USD) and mpMRI (€101,148.06; $110,312.25 USD) comprised 38% of the overall expenditure. Investigators noted total mean expenditures were greater (€523,968.98; $571,441.48 USD) in this arm compared with SoC (€331,393.85; $361,418.71 USD), translating to mean per patient costs of €1300.17 ($1,418.52 USD) in the imaging arm and €830.56 ($906.17 USD) in the SoC arm.1
Using a QALY loss of 0.03 per patient per missed diagnosis, the use of mpMRI in the imaging arm was deemed to be cost-effective with an ICER of €5067.77 ($5,530.28 USD) per 1.02 QALYs gained (€4968.40[$5,421.09 USD]/QALY gained).1
"This study demonstrates that multiparametric MRI is a cost-effective, non-invasive diagnostic tool that can enhance MASLD detection, reduce dependence on liver biopsies, and improve overall healthcare efficiency,” said Henry Chang, executive director of the Fatty Liver Foundation.2 “Diagnostic innovations that streamline clinical workflows while minimizing patient burden, are essential to advancing MASLD care, particularly given the increasing prevalence of the disease.”