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routine clinical care",[13],"Diagnostic Test: Liver Multi Scan",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Liver Multi Scan","MRI to create cT1, T2\\* and PDFF images of patients liver.",[9],[21],"Biopsy",[23],{"name":24,"affiliation":25,"role":26},"Arun Sanyal, M.D.","VCU School of Medicine","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Cayden Beyer","CONTACT","01865655343",null,"cayden.beyer@perspectum.com",[35,55,71,87,102,113,129],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Arizona Liver Health","RECRUITING","Chandler","Arizona","85224","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-111.84125,33.30616,{"lat":47,"lon":46},[50,53],{"name":51,"role":30,"phone":32,"phoneExt":32,"email":52},"David Rios, 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18 gauged needle passed into the right lobe\n* Patients who are suspected of having NAFLD, who are being considered for treatment, and presenting with two or more of the following risk factors for NASH\n* Elevated liver enzymes (ALT≥40)\n* BMI≥25kG\u002Fm\\^2\n* Hypertension\n* Type II diabetes\n* Dyslipidameia\n* Low High-density lipoprotein (HDL) (\\\u003C40mg\u002Fdl in men or \\\u003C50mg\u002Fdl in women)\n* Hypertriglyceridemia (≥150mg\u002Fdl)\n* Hypercholestrolemia (≥200mg\u002Fdl)\n* Triglycerides (TG)\u002FHDL\\>5.0\n\nExclusion Criteria:\n\n* Prior histopathological diagnosis of NASH\n* Inability to undergo a liver biopsy\n* Prior or planned liver transplantation\n* Patient scheduled to undergo a laparoscopic or wedge liver biopsy or biopsy taken from the left lobe\n* Participation in an investigational new drug (IND) trial in the 30 days before enrolment\n* Other known causes of chronic liver disease based on clinical criteria at the study site such as the following:\n* Alcoholic liver disease\n* Primary biliary cirrhosis\n* Primary sclerosing cholangitis\n* Autoimmune Hepatitis\n* Wilson's disease, hemochromatosis, iron overload\n* Alpha\u002F1\u002FAntitrypsin (A1AT) deficiency\n* HCV, HBV\n* History or diagnosis of cirrhosis and or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding\n* Clinically relevant drug or alcohol abuse within 12 months of screening\n* Any contradiction or significant limitation to MRI scanning\n* Claustrophobia preventing MR imaging (requires 15-30 minutes in scanning)\n* Pacemaker or another implanted device\n* Metal in body (such as an aneurysm clip) that might produce artefacts on abdominal MRI or might be adversely impacted by a high magnetic field\n* Inability to lie flat, remain still or briefly hold breath as necessary during MR imaging\n* Medical condition likely to produce significant hypervolemia like congestive heart failure\n* Severe obesity complicating positioning in MR scanner\n* Weight reduction surgery within 3 years\n* Concomitant medical illnesses per investigators discretion (such as HIV infection, recent major surgery, uncontrolled heart disease, concurrent infection or fever of unknown origin, illicit drug use, cancer\n* Clinically significant medical or psychiatric condition considered a high risk participation in an investigational study\n* Failure to give informed consent","ALL","18 Years","75 Years",{"count":162,"type":163},225,"ESTIMATED","INTERVENTIONAL",[166],"NA","To evaluate, in patients with suspected NASH referred for liver biopsy, the diagnostic performance of CT1 at discriminating those with NAS≥4 \\& F≥2 from those without.",[169],"NASH - Nonalcoholic Steatohepatitis","2026-05-18",{"date":172,"type":173},"2026-05-19","ACTUAL",{"date":175,"type":173},"2020-08-05",{"date":177,"type":163},"2026-06-01",{"name":5,"class":6},7]