[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608542":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":33,"responsibleParty":51,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":10,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":79,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Sahlgrenska University Hospital","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Children with established or suspected liver disease",null,"Study 1: All children with suspected or established liver disease referred for at liver biopsy at Queen Silvias Children Hospital during the inclusion period. Their ultrasound based biomarkers will be compared with histology and with ultrasound biomarkers of controls (children without liver disease or conditions affecting the liver, referred for a renal biopsy during the inclusion period)",{"label":13,"type":10,"description":14,"interventionNames":10},"Children who need surveillance of disease and treatment by longitudinal monitoring","Study 2: Several diseases\u002Fconditions are already monitored with conventional ultrasound on a regular basis in children. Examples include cystic fibrosis, liver transplants, severe obesity and failure-associated liver disease (IFALD).",{"label":16,"type":10,"description":17,"interventionNames":10},"Children with MR of the liver","This study (study 3) cohort will include around 50 children who are participating in study 1 and 2, and in whom MRI is clinically indicated as a supplement to ultrasound examination - for example, children with obesity for whom ultrasound may be insufficient or children in whom a more global characterization of the liver is desired.",[19],{"name":20,"affiliation":21,"role":22},"Hanna Hebelka","Institute of clinical sciences, Sahlgrenska Academy, Gothenburg University","PRINCIPAL_INVESTIGATOR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Hanna M Hebelka, Associate Prof.","CONTACT","+46705667867","hanna.hebelka@vgregion.se",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Charlotte de Lange, Assoc.Prof.","+46735367199","charlotte.de.lange@vgregion.se",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Department of Radiology, Queen Silvias Children´s Hospital,Gothenburg Sweden","RECRUITING","Gothenburg","Västra Götaland County","41650","Sweden","SE",{"type":43,"coordinates":44},"Point",[45,46],11.96679,57.70716,{"lat":46,"lon":45},[49],{"name":50,"role":26,"phone":10,"phoneExt":10,"email":10},"Hanna M Hebelka, Senior Consultant Radiology, PhD, Associate Professor",{"type":22,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Hannah Hebelka","Associate Professor",[55],{"name":56,"class":6},"Queen Silvia Children's Hospital, Gothenburg, Sweden","100608542","validation-of-imaging-based-liver-biomarkers-in-pediatric-patients-100608542",false,"NCT07202910","VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients","Imaging-Based Biomarkers for Non-Invasive Pediatric Liver Diagnostics","VALiBi-PED","Inclusion Criteria (Study 1-main study)\n\n* all patients scheduled for a clinically liver biopsy at the Queen Silvia Children's Hospital\n* any form of suspected or confirmed liver disease\n* age between 0-18 years\n* consent by the child\u002Fparents to participate.\n* For controls: children scheduled for a renal biopsy\n* age between 0-18 years\n* consent by the child\u002Fparents to participate.\n\nExclusion Criteria:\n\n* technical limitations regarding the measurements\n* inability to fully understand the informed consent documents.",true,"ALL","25 Years",{"count":69,"type":70},550,"ESTIMATED","OBSERVATIONAL","The goal of this observational (diagnostic validation) study is to validate imaging-based biomarkers for assessing liver involvement in pediatric patients with established or suspected liver disease. The projekt involves 3 larger studies, each with specific aims specified in detailed description below.\n\nThe main study (study 1) compares imaging-based biomarkers-with liver biopsy to evaluate their correlation with histologically confirmed liver disease, including fibrosis, inflammation, and steatosis. The main question the overall project aims to answer is:\n\n• Can multiple novel imaging-based biomarkers, such as shear wave elastography (SWE), shear wave dispersion (SWD), and attenuation imaging (ATI), be used for detailed, non-invasive liver characterization in children, and if so, how should they be used?",[74,75,76,77,78],"Hepatic Disorders","Intestinal Failure-associated Liver Disease","Cystic Fibrosis Liver Disease","MAFLD","Pediatric Liver Transplantation",[80,81,82,83,76,84,85,86,87,77],"pediatric hepatic disease,","obesity and overweight","intestinal failiure associated liver disease","liver transplant disorder","Liver disease or abnormalities","pediatric liver transplant","pediatric abdominal imaging","elastography","2025-09-23",{"date":90,"type":91},"2025-10-02","ACTUAL",{"date":93,"type":91},"2019-03-28",{"date":95,"type":70},"2032-12",{"name":5,"class":6},1]