[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446613":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":57,"collaborators":24,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":24,"enrollmentInfo":69,"targetDuration":24,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":46,"whyStopped":24,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced screening","EXPERIMENTAL","Half-yearly liver ultrasound and fast-MRI",[13],"Other: Liver ultrasound and fast-MRI",{"label":15,"type":16,"description":17,"interventionNames":18},"Screening recommendations","ACTIVE_COMPARATOR","Half-yearly liver ultrasound",[19],"Other: Liver ultrasound",[21,25],{"type":6,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"Liver ultrasound and fast-MRI",[9],null,{"type":6,"name":26,"description":17,"armGroupLabels":27,"otherNames":24},"Liver ultrasound",[15],[29],{"name":30,"affiliation":31,"role":32},"Pierre NAHON, MD, PhD","Assistance Publique Hôpitaux de Paris (AP-HP)","STUDY_DIRECTOR",[34,39],{"name":30,"role":35,"phone":36,"phoneExt":37,"email":38},"CONTACT","1 48 02 62 80","+33","pierre.nahon@aphp.fr",{"name":40,"role":35,"phone":41,"phoneExt":37,"email":42},"David SCHMITZ","1 49 81 36 32","david.schmitz@aphp.fr",[44],{"facility":45,"status":46,"city":47,"state":24,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":24},"Assistance Publique Hôpitaux de Paris - Hôpital Avicenne","RECRUITING","Bondy","93140","France","FR",{"type":52,"coordinates":53},"Point",[54,55],2.48931,48.9018,{"lat":55,"lon":54},{"type":58,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100446613","fast-irm-for-hcc-surveillance-in-patients-with-high-risk-of-liver-cancer-100446613",false,"NCT05095714","FAST-IRM for HCC suRveillance in pAtients With High risK of Liver Cancer.","Randomized Study Evaluating the Cost Impact and Effectiveness of Systematic Liver Fast-MRI Surveillance for Early-stage Hepatocellular Carcinoma in High-risk Patients Included in Ultrasound Surveillance Programs","FASTRAK","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient enrolled in a screening program for at least 6 months in a tertiary hepatology center\n* Cirrhosis histologically proven or unequivocally suggested by non-invasive tests\n* Absence of HCC on imaging less than 3 months o\n* Liver parenchyma explorable by ultrasound\n* Child-Pugh A or B\n* Cirrhosis of non-viral or viral B\u002FC cause controlled\u002Fhealed\n* With an estimated annual risk of HCC\\>3%\n* Written informed consent\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Child-Pugh C score\n* Active hepatitis B or C\n* Estimated annual risk of HCC\\\u003C3%\n* No prior enrollment in a screening program\n* Contraindication to Fast-MRI\n* Non-echogenic patient\n* Patient deprived of liberty\n* Patient under legal protection\n* Pregnant or breastfeeding woman\n* Patient on AME (state medical aid)","ALL","18 Years",{"count":70,"type":71},944,"ESTIMATED","INTERVENTIONAL",[74],"NA","Intro: Hepatocellular carcinoma (HCC) is the 6th leading cause of cancer worldwide. In France, more than 10,000 new cases are identified each year. The latter occur in 85% of cases in cirrhosis, the most frequent causes of which are excessive alcohol consumption, metabolic syndrome or HBV\u002FHCV infection. Patients with cirrhosis justify being included in monitoring programs involving the performance of a semi-annual liver ultrasound (US) in order to detect HCC eligible for curative treatment (liver resection or percutaneous ablation). This practice is considered to be cost-effective in the event of an annual incidence of HCC\\> 1.5%. US in this context has a low sensitivity for the detection of HCC at the very early stage and the following observations have been made in the last 20 years:\n\n* The rate of patients detected at early stage BCLC 0 is around 30% by ultrasound\n* The rate of patients included in surveillance programs detected with advanced HCC eligible for palliative treatment is around 20%\n* Reducing the periodicity of liver ultrasounds from 6 to 3 months does not improve these results.\n\nIn parallel, liver MRI has been evaluated as a tool for the early detection of HCC. Its performance for the detection of HCC at the very early stage exceeds 80%. However, due to the higher cost compared to US, it was estimated that its use in screening context would only be cost effective in the event of an annual incidence\\> 3%. In addition, the practice of these expensive and long-lasting MRIs (30 to 45 minutes) can be optimized by carrying out abbreviated MRI protocols\" or Fast-MRI: short protocols (\\\u003C10 minutes), based on the sequences with the better detection sensitivities (Se\\> 83%).\n\nThe hypothesis is that Fast-MRI used as a screening examination in patients at high risk of HCC (\\> 3% per year) could increase the rates of patients detected at an early stage accessible to curative treatment and demonstrate its cost-effectiveness in this population.\n\nHypothesis\u002FObjective: The main objective is to assess the cost \u002F QALY and \u002F patient detected with an early HCC BCLC 0 (single tumor \\\u003C2cm) by semi-annual monitoring by liver US and Fast-MRI, compared to conventional semi-annual monitoring by liver US alone in patients with cirrhosis and an anticipated HCC incidence\\>3%.\n\nConclusion: If positive, this trial could modify international practice guidelines and set MRI as the optimal tool for early HCC detection in high-risk patients.",[77,78,79,80],"Hepatocellular Carcinoma","Liver Cancer","Cirrhosis","Chronic Liver Disease",[82,83,79,84,85,86,87,88],"Hepatocellular carcinoma","Liver cancer","Chronic liver disease","Surveillance","Detection","MRI","Risk stratification","2026-03-10",{"date":91,"type":92},"2026-03-12","ACTUAL",{"date":94,"type":92},"2022-11-23",{"date":96,"type":71},"2030-06-23",{"name":5,"class":6},1]