The FNIH Announces Study Results Published in Radiology Showing the Potential of MRI Scans to Measure Liver Disease
NORTH BETHESDA, MD, Nov. 21, 2023—The Foundation for the National Institutes of Health (FNIH) highlights findings, published in Radiology, from a study that evaluated the potential of MRI (magnetic resonance imaging) biomarkers to measure liver fat, fibrosis, and body composition in participants at risk for nonalcoholic steatohepatitis (NASH). The results show that, with further validation, noninvasive MRI biomarkers could be qualified through the Food and Drug Administration (FDA) for clinical trial use.
“With full regulatory approval, imaging biomarkers will greatly expand access to care for patients with early-stage liver disease,” said Tania Kamphaus, PhD, Director of Translational Science, Metabolic Disorders, and Director of Patient Engagement at the FNIH. “The use of imaging in clinical trials will also make it easier to recruit patients to research new treatments.” Dr. Kamphaus and Dr. Alex Pasek, FNIH Project Manager, Metabolic Disorders, are co-authors of the Radiology article.
The research is part of the FNIH’s Noninvasive Biomarkers of Metabolic Liver Disease (NIMBLE) project, a public-private partnership bringing together government agencies, academic researchers, and industry partners to rigorously evaluate blood and imaging tests to measure the presence of liver disease. The study findings on MRI biomarkers follow a recent publication in Nature Medicine showing the potential of noninvasive blood tests as a diagnostic tool.
NASH is a common cause of liver disease and a leading cause of liver-related morbidity and mortality. It affects up to 15 million people in the United States. Currently, the only method to diagnose NASH with certainty is a liver biopsy, a painful and expensive procedure that carries some risk of complications and death for patients. Because of the limitations associated with liver biopsy, a strong need exists for noninvasive tests to diagnose and monitor the disease in patients and to facilitate clinical trials for new treatments.
Researchers enrolled a total of 17 patients with nonalcoholic fatty liver disease (NAFLD) and suspected NASH and performed MRI scans using six different MRI scanners. For maximum analysis, each participant underwent four MRI scans the first day, and two to three MRI scans the second day, which were performed around the same time of day within a seven-day interval.
The findings indicate that MRI readings are consistent across most MRI machines. This means patients could have more flexibility in choosing an MRI provider for follow-ups, and clinical trials using MRIs would no longer need to select sites based on the MRI manufacturer. While these noninvasive MRI markers show promise, further validation of their repeatability and reproducibility in patients with NAFLD is needed to qualify them through the FDA as biomarkers for clinical trial use.
“I had frequent MRIs during my liver disease journey, particularly in the later stages” said liver patient and transplant recipient Tony Villiotti. “One of my frustrations with the process was having to return to the same health center for each of the MRIs. This was inconvenient and disruptive to both me and my family. The flexibility the results of this study provides is welcomed by the patient community in the hopes that it will lead to more options and better access to care.”
Working alongside dedicated patient advocacy groups in the NASH space—including the Global Liver Institute, NASH Knowledge, and the Fatty Liver Foundation—the FNIH is contributing its expertise to enhance research and drive patient-centered initiatives to address this pressing health issue. For more information about NIMBLE, visit Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) | FNIH.
NIMBLE is a project of the FNIH Biomarkers Consortium, which leads cross-sector efforts to validate and qualify biomarkers that accelerate the development of new therapeutics and health technologies. Biomarkers Consortium partners include the National Institutes of Health, the FDA, private industry, and nonprofit organizations.
About the Foundation for the National Institutes of Health: The Foundation for the National Institutes of Health (FNIH) builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH), life sciences companies, foundations, academia, and regulatory agencies, including the Food and Drug Administration and European Medicines Agency. Through team science, we solve complex health challenges and accelerate breakthroughs for patients, regardless of who they are or what health challenges they face. The FNIH accelerates new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and helps train the next generations of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org.
 In June 2023, numerous global liver associations introduced a revised terminology. The condition known as nonalcoholic steatohepatitis (NASH) is now known as metabolic dysfunction-associated steatohepatitis (MASH). FNIH acknowledges this advancement and actively collaborates with the patient and expert liver disease sectors to appropriately integrate the change.