protocolSection identificationModule nctId: NCT06373536, orgStudyIdInfo id: LMU-RAD-01167, briefTitle: Comparison of MRI-PDFF to TAEUS FLIP Device to Estimate Liver Fat Fraction in Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Endra Lifesciences, class: INDUSTRY, descriptionModule briefSummary: Primary nonalcoholic fatty Liver disease (NAFLD) is an excess of fat in the liver (steatosis) that is not a result of excessive alcohol consumption or other secondary causes11. NAFLD is defined by the presence of hepatic fat content (steatosis) in ≥ 5% of hepatocytes and is currently the most common liver disease worldwide14 . Non-Alcoholic Fatty Liver Disease (NAFLD) is the world\&#39;s most common liver disease and affects around 33% of the adult population.Nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease (NAFLD), is a growing clinical concern associated with the increasing prevalence of obesity, type 2 diabetes, and metabolic syndrome. NASH is characterized by the presence of hepatic steatosis, inflammation, and hepatocellular injury and is predicted to be the leading indication for liver transplantation by 20201. Patients with NASH have an increased risk of developing cirrhosis and its complications, such as ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, and liver failure. The prevalence worldwide of NAFLD in the general population is estimated at 20-35%2 . Around 2-3% of the population have NASH.In patients with type 2 diabetes, the prevalence is even over 50% (55.5% globally, 68% in Europe). In Germany, the NAFLD prevalence was 23% in 2016 and will be around 26% in 2030. The prevalence of non-alcoholic alcoholic steatohepatitis (NASH), i.e. the progressive form of NAFLD, is estimated at 4% of the adult population in Germany and will increase to 6% by 2030. This means that NAFLD is already the most common chronic liver disease worldwide and one of the leading causes of liver-related complications (cirrhosis, decompensation, hepatocellular carcinoma, liver transplantation) and deaths. NAFLD and NASH are largely underdiagnosed worldwide., conditionsModule conditions: Steatosis of Liver, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Thermoacoustic imaging, MRI and Ultrasound imaging, outcomesModule primaryOutcomes measure: Thermoacoustic Fat Measurements, primaryOutcomes measure: Estimate Accuracy of Thermoacoustic Fat Fraction, secondaryOutcomes measure: Usability Metric, secondaryOutcomes measure: Estimate Operator Variability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Klinikum der Universität München Großhadern Klinik und Poliklink für Radiologie, city: München, zip: 81377, country: Germany, contacts name: Monika Dienst, M.Sc., role: CONTACT, phone: +49 89 4400 76642, email: monika.dienst@med.uni-muenchen.de, contacts name: Dirk-Andre Clevert, Prof. Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.13743, lon: 11.57549, hasResults: False