Children who currently have to undergo biopsies to diagnose their liver disease could in future be saved from this procedure, after a €1.1M grant was awarded to a UK-Poland consortium to develop a Magnetic Resonance Imaging (MRI)-based medical device for children.
One in five children in Europe suffer from fatty liver disease, but clinical symptoms only surface at later stages when treatment options are limited. Early detection would have a massive impact on how this disease is managed, but the current diagnostic is a painful, invasive biopsy, as Professor Piotr Socha, from the Children's Memorial Health Institute in Warsaw, explains:
"Liver biopsy is important for making diagnosis of various liver diseases and is frequently used in follow up to make decisions on therapy. We try to decrease indications for liver biopsy in children because it can cause complications and needs sedation and anesthesia."
LiverMultiScan uses a painless, 15 minute MRI scan which characterises liver tissue. Developed by Perspectum Diagnostics in Oxford, UK, this test already has regulatory clearance for use in adults to aid physicians in diagnosing early liver disease.
Dr Rajarshi Banerjee, CEO of Perspectum, says: "We know so little about pediatric liver diseases and their natural history because, until now, we have been limited in our ability to diagnose and follow these children up. MRI is safe, easy to perform and communicate to patients and families with clear images, and will help us find and treat the thousands of children in Europe who currently only get diagnosed late, if at all, because of the need for liver biopsy."
Supported by funding from EUREKA/Eurostars, the Kids4LIFe consortium will develop and validate LiverMultiScan specifically for patients under 16. In a clinical trial, children who would normally undergo liver biopsy as part of their usual care will also be offered a LiverMultiScan. The information gathered from this study will help the consortium understand how and when the technology is best used in the diagnosis of pediatric liver disease.
As part of the project, a cloud-based health data management system will be developed by the Polish telemedicine company Silvermedia. This platform will allow rapid transfer of liver scans, as well as other health information and diagnostic test results, between local pediatricians and experts in other cities and countries.
LiverMultiscan is now installed in medical institutions on three continents. Used in the clinical management of patients with chronic liver disease, the technology offers a quantitative liver assessment in a safe, non-invasive 15-minute MRI scan. Analysis is based on assessment of native properties of liver tissue, accurate measurement of liver fat and other metrics. The technology is currently being used to assess primary endpoints in clinical trials for investigational therapies to treat NAFLD and NASH. LiverMultiScan is manufactured by Mirada Medical, and has CE-marking and FDA-clearance.
About Perspectum Diagnostics
Perspectum Diagnostics is a medical imaging company founded by scientists and physicians from the University of Oxford. It has pioneered the use of quantitative magnetic resonance imaging (MRI) to accurately detect and measure biomarkers of liver disease.
Silvermedia, based in Cracow, Poland is a leading provider of telemedicine solutions in cardiology, audiology and gerontology. Having ISO13485 certification, the company delivers web based, scalable, multi-domain systems, including state-of-the-art applications for the most popular mobile platforms.