[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100299240":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":26,"responsibleParty":44,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":10,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":10,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients with autoimmune liver disease",null,"Patients (6-23 y.o.) with established clinical diagnosis of AIH or suspected diagnosis of AIH based on elevated serum AST or ALT, elevated IgG level \\>1.1 ULN, elevated titer of autoantibodies, including ANA, SMA, LKM, LC-1 or SLA, which is consistent with the simplified criteria for the diagnosis of AIH in children will be enrolled.\n\nPatients (6-23 y.o.) with established clinical diagnosis of PSC or Suspected diagnosis of PSC supported by abnormal cholangiogram (ERCP or MRCP) or elevated GGT\\>1.5 ULN and dilated bile ducts by liver ultrasound will be enrolled.",[13],{"name":14,"affiliation":15,"role":16},"Alexander Miethke, MD","Cincinnati Childrens Hospital Medical Center","PRINCIPAL_INVESTIGATOR",[18,22],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},"CONTACT","513-636-8948","Alexander.Miethke@cchmc.org",{"name":23,"role":19,"phone":24,"phoneExt":10,"email":25},"Cyd Castro Rojas, PhD","513-517-0580","Cyd.CastroRojas@cchmc.org",[27],{"facility":15,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Cincinnati","Ohio","45229","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-84.51439,39.12711,{"lat":38,"lon":37},[41,43],{"name":14,"role":19,"phone":42,"phoneExt":10,"email":21},"513-636-5581",{"name":14,"role":16,"phone":10,"phoneExt":10,"email":10},{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100299240","mri-based-biomarkers-in-pediatric-autoimmune-liver-disease-100299240",false,"NCT03175471","MRI Based Biomarkers in Pediatric Autoimmune Liver Disease","Cross-sectional Study for Assessment of MRI Based Biomarkers of Bile Duct Injury and Hepatic Fibrosis in Pediatric Onset Autoimmune Liver Disease","Inclusion Criteria:\n\n1. Age 6-23 years old.\n2. Established or suspected clinical diagnosis of AIH or PSC.\n\nExclusion Criteria:\n\n1. History of liver transplantation.\n2. Chronic Hepatitis B or untreated hepatitis C virus infection.\n3. Pregnancy.\n4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).\n5. Diagnosis of cystic fibrosis or biliary atresia\n6. Diagnosis of cardiac hepatopathy.\n7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.\n8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).","ALL","6 Years","23 Years",{"count":57,"type":58},115,"ESTIMATED","OBSERVATIONAL","Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among adolescents. In all these conditions, autoimmune lymphocyte responses are thought to orchestrate inflammatory injury against hepatocytes (primarily in AIH) or cholangiocytes (in PSC). In this proposal we aim to evaluate the Magnetic Resonance Imaging (MRI) modalities; MR cholangiopancreatography (MRCP) and MR elastography (MREL), as non-invasive biomarkers to assess two primary pathophysiological processes of AILD: bile duct damage and liver fibrosis. In this cross-sectional study MRI based findings of bile duct injury and liver fibrosis will be correlated with both liver histology and circulating biomarkers of these disease processes.",[62,63,64],"Autoimmune Liver Disease","Primary Sclerosing Cholangitis","Autoimmune Hepatitis","2024-12-09",{"date":67,"type":68},"2024-12-12","ACTUAL",{"date":70,"type":68},"2017-01-17",{"date":72,"type":58},"2027-01-30",{"name":5,"class":6},1]