[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436606":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":26,"centralContacts":31,"locations":42,"responsibleParty":65,"collaborators":68,"id":72,"slug":36,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":36,"enrollmentInfo":81,"targetDuration":36,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":44,"whyStopped":36,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Queen's Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tested with Biomarkers","EXPERIMENTAL","For this single arm study, all enrolled subjects will undergo diagnostic testing with FCH PET\u002FCT and genomic liquid biopsy before treatment involving an immune checkpoint inhibitor agent. A fluorine-18 fluorodeoxyglucose (FDG) PET\u002FCT may also be performed before treatment and after 8 weeks if the pre-treatment FCH PET\u002FCT shows low or heterogeneous tumor uptake.",[13],"Combination Product: Fluorine-18 fluorocholine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","Fluorine-18 fluorocholine","18F-fluorocholine is a radiopharmaceutical imaging agent intended for use only with positron emission tomography (PET) imaging. PET with in-line computed tomography imaging of the torso will be performed following intravenous administration of a single unit dose of this investigational new drug.",[9],[21,22,23,24,25],"18F-fluorocholine","Fluorocholine","18F-FCH","FCH","[18F]fluorocholine",[27],{"name":28,"affiliation":29,"role":30},"Sandi A Kwee, MD, PhD","The Queen's Medical Center","PRINCIPAL_INVESTIGATOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Abrar M Al-Adhmi, BS","CONTACT","808-691-7429",null,"aaadhmi@queens.org",{"name":39,"role":34,"phone":40,"phoneExt":36,"email":41},"Tim Kelleher, RN","808-691-8582","tkelleher@queens.org",[43],{"facility":29,"status":44,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Honolulu","Hawaii","96813","United States",{"type":50,"coordinates":51},"Point",[52,53],-157.85833,21.30694,{"lat":53,"lon":52},[56,60,64],{"name":57,"role":34,"phone":58,"phoneExt":36,"email":59},"Miles Sato, MS","808-691-8584","msato@queens.org",{"name":61,"role":34,"phone":62,"phoneExt":36,"email":63},"Sandi A Kwee, MD","808-691-5466","skwee@queens.org",{"name":61,"role":30,"phone":36,"phoneExt":36,"email":36},{"type":30,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Sandi Kwee","Program Director, PET Research",[69],{"name":70,"class":71},"National Cancer Institute (NCI)","NIH","100436606",false,"NCT04965454","Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma","Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma","ExTRACT-HCC","Inclusion Criteria:\n\n* Age 18 years or older (no upper limit of age)\n* Hepatocellular carcinoma diagnosis made histologically or radiographically in accordance to National Comprehensive Cancer Network guidelines (3.2019 version or higher)\n* Does not qualify for surgical resection or locoregional therapy alone or has disease that has progressed after surgical resection and\u002For locoregional therapy\n* Has measurable disease defined as at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 on CT\u002FMRI completed within past 6 weeks of eligibility screening\n* Under the care of a licensed medical oncologist\n* Life expectancy \\> 6 months\n* Deemed eligible for treatment with an immune checkpoint inhibitor agent based on the treating medical oncologist's assessment of previous treatment failure, clinical\u002Fperformance\u002Fvirology status, and liver\u002Frenal\u002Fhematologic function.\n* Child-Pugh score of 9 or less\n* Creatinine clearance ≥ 40 mL\u002Fmin, measured or calculated using the Cockcroft-Gault formula\n* ALT and AST ≤7x upper limit of normal\n* Total bilirubin ≤4 mg\u002FdL\n* Albumin ≥2.8 g\u002FdL\n\nExclusion Criteria:\n\n* Weight \\> 500 lbs (PET\u002FCT limit)\n* Pregnant or lactating female (those of child-bearing potential must be re-screened within 7 days prior to PET\u002FCT imaging)\n* Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure\n* Concurrent treatment with a non-targeted therapeutic agent. Concurrent enrollment in an ICI-treatment trial and combination ICI treatment are allowed.","ALL","18 Years",{"count":82,"type":83},80,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","This prospective clinical trial will evaluate PET\u002FCT and genomic liquid biopsy based biomarkers as predictors of clinical therapeutic response to immune-checkpoint inhibitor (ICI) therapy for patients with inoperable hepatocellular carcinoma (HCC). The primary objective of this diagnostic trial is to assess the accuracy of pre-treatment fluorine-18 (18F-) fluorocholine (FCH) PET\u002FCT for predicting a lack of objective response (LOR) after 16 weeks of ICI therapy.",[89],"Hepatocellular Carcinoma Non-resectable",[91,92,93,94,95,96,97,98,99],"hepatocellular carcinoma","immunotherapy","positron emission tomography","mutation profiling","liquid biopsy","personalized medicine","diagnostic","fluorocholine","immune checkpoint inhibitor","2025-04-28",{"date":102,"type":103},"2025-05-01","ACTUAL",{"date":105,"type":103},"2022-03-28",{"date":107,"type":83},"2028-06-30",{"name":5,"class":6},1]