A multi-national prospective study across Germany, the Netherlands, Portugal, and the UK evaluated LiverMultiScan (Perspectum), an AI-enabled multiparametric MRI (mpMRI) tool that quantifies liver fat, inflammation (cT1), and iron to improve diagnosis and risk stratification in suspected metabolic dysfunction–associated liver disease (MASLD). 802 participants were randomized to receive standard-of-care (SoC) alone or SoC plus mpMRI. The study assessed diagnostic impact, healthcare resource use, and cost-effectiveness in real-world clinical settings.
Patients in the imaging arm had significantly higher diagnostic confirmation rates (57% vs. 48%, p = 0.0012) and required fewer specialist consultations and assessments. Using a cT1 threshold of <875 ms, mpMRI could have avoided 45% of liver biopsies deemed unnecessary, with 90% sensitivity and 83% negative predictive value for ruling out MASH with fibrosis. While the imaging group had higher short-term costs (€1,300 vs. €830 per patient), mainly due to imaging expenses, the intervention yielded greater efficiency and a cost-effectiveness ratio of €4,968 per QALY gained, well within acceptable thresholds.
The study concludes that LiverMultiScan enhances diagnostic accuracy, supports biopsy avoidance, and is cost-effective, offering a standardized, noninvasive approach for earlier and safer MASLD management.
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Utility and cost-effectiveness of LiverMultiScan for MASLD diagnosis: a real-world multi-national randomised clinical trial
Communications Medicine, 2025
Abstract
Background
Increasing prevalence of metabolic dysfunction-associated liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) poses a growing healthcare burden. Noninvasive diagnostic tools to replace liver biopsy are urgently needed. We investigated the utility and cost-effectiveness of including multiparametric magnetic resonance imaging (mpMRI) to the management of adults with suspected MASLD multi-nationally.
Methods
RADIcAL-1, a 1:1 randomised controlled trial (standard-of-care [SoC] vs. imaging arm [IA; SoC+mpMRI]) included 802 participants from Germany, Netherlands, Portugal and UK. Wilcoxon-rank tests were used to compare access to healthcare practitioners, patient assessments and proportion of patients with a diagnosis (%diagnosis). Liver fat and disease activity (corrected T1 [cT1]) were used to identify patients not requiring biopsy in the imaging arm. Primary endpoint was mpMRI cost-effectiveness and improvement in resource use (visits avoided) using mpMRI.
Results
mpMRI is cost-effective with an ICER of €4968/QALY gained. 403 were randomised to IA and 399 to SoC. SoC has significantly more specialist appointments (p = 0.015) and patient assessments (p < 0.001). Across all involved hospitals, %diagnosis is significantly higher in the imaging arm (p = 0.0012). cT1 correctly classifies 50% of patients without MASH with fibrosis and can avoid biopsy. Including all costs, the imaging arm incurs higher short-term per-patient healthcare expenditure compared to the SoC arm (€1,300 vs. €830).
Conclusion
Adding mpMRI to SoC for the management of adults with suspected MASLD multi-nationally is cost-effective, enhances rate of diagnosis multi-nationally and increases rate of diagnosis without increasing other liver-related health care resource use. Due to the need for standardisation of SoC, widespread use can support optimisation of the MASLD clinical pathway and improve long-term patient management.