Two recently published studies support the use of quantitative MRI imaging as a non-invasive alternative to liver biopsies in managing patients with metabolic dysfunction-associated steatohepatitis (MASH). The research, conducted by Perspectum, demonstrates the accuracy and reproducibility of MRI biomarkers in identifying disease and predicting treatment response, potentially reducing the need for invasive procedures in clinical trials and patient care.
The first study highlights the ability of non-invasive quantitative MRI scans to accurately and reproducibly identify MASH. The second study, analyzing data from three multicenter clinical trials, reveals that changes in MRI biomarkers can predict biopsy changes in patients, indicating who is likely to respond to drug treatment. Notably, an 80ms reduction in cT1, a proprietary MRI metric, was predictive of histological response.
Potential to Replace Liver Biopsies
The current gold standard for assessing liver disease in MASH clinical trials is liver biopsy, an invasive procedure with inherent risks and limitations. The new research suggests that non-invasive tests (NITs), particularly quantitative MRI, can reliably monitor changes in liver health, potentially reducing the reliance on biopsies.
Dr. Rajarshi Banerjee, CEO of Perspectum, emphasized the advantages of quantitative MRI, stating, "Liver biopsy is not a safe or accurate way of assessing liver disease. Quantitative MRI is far safer, more scalable and authorized for clinical use. With more published data, the argument for replacing liver biopsy with quantitative MRI both in clinical practice and in clinical trials becomes stronger."
Clinical Implications and Future Directions
The ability to predict treatment response using MRI biomarkers has significant implications for the development and management of MASH. With the recent FDA approval of Rezdiffra, the first therapeutic for MASH, and a robust pipeline of drugs in development, the need for reliable and non-invasive monitoring tools is growing.
Eli Lilly’s tirzepatide, which demonstrated a significant reduction in cT1 and liver fat over 52 weeks in patients with Metabolic dysfunction-associated steatotic liver disease (MASLD), further underscores the potential of MRI as a valuable tool in assessing treatment efficacy. The research suggests that pharmaceutical companies and regulatory entities may increasingly consider NITs as a means to measure disease change and monitor patient progress non-invasively.
Dr. Naim Alkhouri, Chief Medical Officer, Chief of Transplant Hepatology, and Director of the Fatty Liver Program at Arizona Liver Health, and the study’s lead author, noted, "Establishing a threshold for cT1 reduction that can predict histologic improvement in terms of MASH resolution and fibrosis improvement will have great implications for the field and may help replace the need for liver biopsy in MASH clinical trials in the future."
About LiverMultiScan
LiverMultiScan, an FDA-cleared technology developed by Perspectum, utilizes multiparametric magnetic resonance imaging (MRI) to assess signs of liver disease. It quantifies liver disease activity and severity (using cT1), fat, and iron content, providing a comprehensive picture of liver health. This technology addresses a critical unmet need for non-invasive techniques to diagnose and monitor patients with chronic liver diseases, including nonalcoholic steatohepatitis, autoimmune hepatitis, and viral hepatitis.
