[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100366672":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":148,"collaborators":32,"id":150,"slug":32,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":32,"eligibilityCriteria":155,"healthyVolunteers":151,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":32,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":32,"overallStatus":37,"whyStopped":32,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Perspectum","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study-gate","EXPERIMENTAL","Single arm of biopsy naïve participants suspected of having NAFLD or NASH, who have been referred for a liver biopsy as part of 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",[35,54,70,86,101,112,128],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Arizona Liver Health","RECRUITING","Chandler","Arizona","85224","United States",{"type":43,"coordinates":44},"Point",[45,46],-111.84125,33.30616,{"lat":46,"lon":45},[49,52],{"name":50,"role":30,"phone":32,"phoneExt":32,"email":51},"David Rios, MD","drios@azliver.com",{"name":53,"role":26,"phone":32,"phoneExt":32,"email":32},"Naim Alkhouri, MD",{"facility":55,"status":37,"city":56,"state":57,"zip":58,"country":41,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"RUSH University Medical Center","Chicago","Illinois","60612",{"type":43,"coordinates":60},[61,62],-87.65005,41.85003,{"lat":62,"lon":61},[65,68],{"name":66,"role":30,"phone":32,"phoneExt":32,"email":67},"Lelani Fetrow, BSN","Lelani_C_Fetrow@rush.edu",{"name":69,"role":26,"phone":32,"phoneExt":32,"email":32},"Nancy Reau, MD",{"facility":71,"status":37,"city":72,"state":73,"zip":74,"country":41,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Indiana University Health","Indianapolis","Indiana","46202",{"type":43,"coordinates":76},[77,78],-86.15804,39.76838,{"lat":78,"lon":77},[81,84],{"name":82,"role":30,"phone":32,"phoneExt":32,"email":83},"Sreemala Murthy, BSc","srmurthy@iu.edu",{"name":85,"role":26,"phone":32,"phoneExt":32,"email":32},"Raj Vuppalanchi, MD",{"facility":87,"status":37,"city":88,"state":88,"zip":89,"country":41,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Icahn School of Medicine at Mount Sinai","New York","10029",{"type":43,"coordinates":91},[92,93],-74.00597,40.71427,{"lat":93,"lon":92},[96,99],{"name":97,"role":30,"phone":32,"phoneExt":32,"email":98},"Elianna Sanchez","elianna.sanchez@mssm.edu",{"name":100,"role":26,"phone":32,"phoneExt":32,"email":32},"Douglas Dieterich",{"facility":102,"status":103,"city":104,"state":105,"zip":106,"country":41,"cosmosGeoPoint":107,"geoPoint":111,"contacts":32},"Liver Center of Texas","ACTIVE_NOT_RECRUITING","Dallas","Texas","75234",{"type":43,"coordinates":108},[109,110],-96.80667,32.78306,{"lat":110,"lon":109},{"facility":113,"status":37,"city":114,"state":115,"zip":116,"country":41,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"University of Virginia","Charlottesville","Virginia","22908",{"type":43,"coordinates":118},[119,120],-78.47668,38.02931,{"lat":120,"lon":119},[123,126],{"name":124,"role":30,"phone":32,"phoneExt":32,"email":125},"Cheree Denbee","cjd4a@hscmail.mcc.virginia.edu",{"name":127,"role":26,"phone":32,"phoneExt":32,"email":32},"Zachary Henry",{"facility":129,"status":37,"city":130,"state":115,"zip":131,"country":41,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Virginia Common wealth University","Richmond","23284",{"type":43,"coordinates":133},[134,135],-77.46026,37.55376,{"lat":135,"lon":134},[138,142,146],{"name":139,"role":30,"phone":140,"phoneExt":32,"email":141},"Arun Sanyal, MD","8048284060","arun.sanyal@vcuhealth.org",{"name":143,"role":30,"phone":144,"phoneExt":32,"email":145},"Rebecca Collen, BSC","8048280100","rebeccs.collen@vcuhealth.org",{"name":147,"role":26,"phone":32,"phoneExt":32,"email":32},"Arun Sanyal",{"type":149,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100366672",false,"NCT04054310","Non-Invasive Quantification of Liver Health in NASH (N-QUAN)","Non-Invasive Quantification of Liver Health in NASH (N-QUAN): A Prospective Diagnostic Accuracy Study","Inclusion Criteria:\n\n* Male and Female subjects aged between 18 and 75 years old\n* Ability to understand and sign a written informed consent forms\n* Patients scheduled to undergo a standard of care diagnostic liver biopsy as follows\n* Percutaneous biopsy with a 16 gauged needle passed into the right lobe\n* Trans-jugular biopsy with an 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":160,"type":161},225,"ESTIMATED","INTERVENTIONAL",[164],"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.",[167],"NASH - Nonalcoholic Steatohepatitis","2026-05-18",{"date":170,"type":171},"2026-05-19","ACTUAL",{"date":173,"type":171},"2020-08-05",{"date":175,"type":161},"2026-06-01",{"name":5,"class":6},7]