Liver MRI software developer Perspectum Diagnostics said a consortium of hospitals has received a multimillion euro grant to evaluate its LiverMultiScan software as a possible replacement for liver biopsy in diagnosing nonalcoholic fatty liver disease (NAFLD).
In a study supported by the EU's Horizon 2020 small- and medium-sized (SME) funding instrument, the Rapid Assessment and Diagnosis in Chronic Adult Liver disease (RADiCAL) trail will compare the cost of patient care using liver biopsy with that of LiverMultiScan, which offers quantitative liver assessment from a 15-minute MRI scan, Perspectum said. A total of 2,000 patients suspected of having NAFLD will be recruited to centers in Germany, the Netherlands, and Portugal.
Each patient will be randomized to either follow the current diagnostic pathway of liver biopsy, or to receive a LiverMultiScan study to determine the presence and extent of disease. The researchers will then determine the cost-effectiveness and patient-reported outcome measures for the two diagnostic pathways, according to Perspectum, which was founded by scientists and physicians from the University of Oxford in the U.K.
LiverMultiScan was developed by Perspectum and is manufactured by imaging software developer Mirada Medical. It has both U.S. Food and Drug Administration (FDA) clearance and the CE Mark, Perspectum said.