[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100329687":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":27,"locations":37,"responsibleParty":69,"collaborators":71,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":10,"enrollmentInfo":89,"targetDuration":10,"studyType":92,"phases":10,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NAFLD, NASH patients",null,"All patients enrolled will undergo:\n\n* Acoustic Radiation Force Impulse (ARFI)\n* Magnetic Resonance Elastography (MRE)",[13],"Device: Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE)",{"label":15,"type":10,"description":11,"interventionNames":16},"Non-obese volunteers",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DEVICE","Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE)","Acoustic Radiation Force Impulse (ARFI), Magnetic Resonance Elastography (MRE)",[9,15],[24],{"name":25,"affiliation":5,"role":26},"An Tang, MD, MSc","STUDY_DIRECTOR",[28,33],{"name":25,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","514-890-8000","36400","an.tang@umontreal.ca",{"name":34,"role":29,"phone":30,"phoneExt":35,"email":36},"Assia Belblidia","34369","assia.belblidia.chum@ssss.gouv.qc.ca",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Centre Hospitalier de l'Université de Montréal","RECRUITING","Montreal","Quebec","H2X 0A9","Canada","CA",{"type":47,"coordinates":48},"Point",[49,50],-73.58781,45.50884,{"lat":50,"lon":49},[53,56,59,61,63,65,67],{"name":54,"role":29,"phone":30,"phoneExt":55,"email":32},"An Tang, MD,MSc","8450",{"name":57,"role":58,"phone":10,"phoneExt":10,"email":10},"Guy Cloutier, MD, PhD","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":10,"phoneExt":10,"email":10},"Jeanne-Marie Giard, MD",{"name":62,"role":58,"phone":10,"phoneExt":10,"email":10},"Guillaum Gilbert, Ing.",{"name":64,"role":58,"phone":10,"phoneExt":10,"email":10},"Bich Nguyen, MD",{"name":66,"role":58,"phone":10,"phoneExt":10,"email":10},"Giada Sebastiani, MD",{"name":68,"role":58,"phone":10,"phoneExt":10,"email":10},"Miguel Chagnon, Statiscian",{"type":70,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[72,74,77],{"name":73,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"name":75,"class":76},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":78,"class":6},"Centre de Recherche du Centre Hospitalier de l'Université de Montréal","100329687","quantitative-ultrasound-techniques-for-diagnosis-of-nonalcoholic-steatohepatitis-100329687",false,"NCT03572465","Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis","QUS in NASH","Inclusion Criteria:\n\n* Are at least 18 years old at screening;\n* Able to comprehend and willingness to provide voluntary consent;\n* Understand French or English;\n* NAFLD\u002FNASH subjects:\n\n  * Have a suspected or known NAFLD or NASH;\n  * Must undergo a liver biopsy as part of their clinical standard of care\n* Non-NAFLD volunteers:\n\n  * Do not have a suspected or known NAFLD or NASH\n\nExclusion Criteria:\n\n* Are pregnant or trying to become pregnant;\n* Have a weight or girth preventing them from entering the MR magnet bore;\n* Are unable to understand or unwilling to provide written informed consent for this study;\n* Non-NAFLD volunteers:\n\n  * Have risk factors for developing liver steatosis (type 2 diabetes mellitus, alcohol consumption \\>60g of alcohol per day, lipogenic medication and body mass index \\>25 kg\u002Fm2);\n  * Have a liver steatosis (defined as MRI-proton density fat fraction \\\u003C5%);\n* NAFLD\u002FNASH subjects:\n\n  * Have other causes of chronic liver disease;\n  * Have a liver transplant",true,"ALL","18 Years",{"count":90,"type":91},102,"ESTIMATED","OBSERVATIONAL","Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH). If left untreated, NASH can evolve to cirrhosis, the late stage of fibrosis. Once cirrhosis is established, patients are at increased risk of developing gastrointestinal bleeding, liver cancer and liver failure that may require transplantation. A liver biopsy is currently needed to diagnose the severity of fatty liver disease but this is usually not indicated in asymptomatic patients. This procedure requires the insertion of a needle inside the liver to remove a small piece of tissue for examination under microscope. Liver biopsy is an invasive procedure with a small risk of major complications such as bleeding in 0.5% of cases. It is also affected by sub-optimal sampling leading to diagnostic errors\n\nUltrasound is optimum for screening patients with or without symptoms because it is a safe and widely available technology to scan the whole liver. Members of our team have developed Advanced ultrasound techniques that provide unique information not possible with state-of-the-art techniques. Unlike liver biopsy, these techniques would be applicable even in asymptomatic patients because it is non-invasive. This research proposal proposes a novel approach for diagnosis of NASH and will be the first study to measure individual components of NASH (fat, inflammation and fibrosis) with quantitative ultrasound (QUS) scores. This study is timely because NASH is the second leading cause of liver transplantation in North America and is predicted to become the leading indication in the near future.",[95,96],"Nonalcoholic Fatty Liver Disease (NAFLD)","Nonalcoholic Steatohepatitis (NASH)",[98,99,100,101,102,103,104],"Chronic liver disease","Fibrosis","Elastography","Ultrasound","Magnetic resonance elastography","Diagnostic performance","Sensitivity and specificity","2025-03-14",{"date":107,"type":108},"2025-03-18","ACTUAL",{"date":110,"type":108},"2019-10-23",{"date":112,"type":91},"2026-02-28",{"name":5,"class":6},1]