[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653998":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":32,"interventions":39,"overallOfficials":44,"centralContacts":48,"locations":54,"responsibleParty":72,"collaborators":25,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":25,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":25,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":90,"conditions":91,"keywords":25,"overallStatus":56,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":25},[9,13],{"measure":10,"description":11,"timeFrame":12},"To evaluate the diagnostic efficacy of 18F-X12 PET\u002FCT for hepatocellular carcinoma (HCC).","We calculated the diagnostic sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-X12 positron emission tomography (PET) imaging for patients with hepatocellular carcinoma (HCC), with histopathological results as the diagnostic gold-standard reference.","From study completion to 1 month after completion",{"measure":14,"description":15,"timeFrame":16},"Incidence of Adverse Events [Safety and Tolerability]","Clinical symptoms and adverse events (e.g., fever, rash, hypoglycemia) will be monitored within 24 hours after injection, and graded according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 6.0).","24 hours after the injection of 18F-X12",[18,22],{"measure":19,"description":20,"timeFrame":21},"Standardized Uptake Values of Primary and Metastatic Lesions on ¹⁸F-X12 PET\u002FCT versus ¹⁸F-FDG PET\u002FCT","Comparison of the maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) of primary and metastatic lesions between 18F-X12 positron emission tomography\u002Fcomputed tomography (PET\u002FCT) and 18F-fluorodeoxyglucose (FDG) PET\u002FCT.","From the date of study completion up to 1-month post-completion",{"measure":23,"description":24,"timeFrame":21},"Correlation between 18F-X12 Uptake and GPC3 Pathological Expression","We evaluated the correlation between uptake parameters derived from 18F-X12 positron emission tomography\u002Fcomputed tomography (PET\u002FCT) and Glypican-3 (GPC3) expression levels measured by immunohistochemistry (IHC) in tumor tissue samples.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE",[33],{"label":34,"type":35,"description":36,"interventionNames":37},"18F-X12 PET\u002FCT","EXPERIMENTAL","The objective is to evaluate the diagnostic efficacy and safety of the novel radiotracer 18F-X12 in patients with hepatocellular carcinoma (HCC).",[38],"Diagnostic Test: 18F-X12 PET\u002FCT",[40],{"type":41,"name":34,"description":42,"armGroupLabels":43,"otherNames":25},"DIAGNOSTIC_TEST","Participants will receive a single intravenous injection of 18F-X12, and undergo PET\u002FCT imaging approximately 120 minutes after radiotracer administration.",[34],[45],{"name":46,"affiliation":5,"role":47},"Meng Liu","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":25,"email":53},"Meixi Chen","CONTACT","+86 010-83575252","2511210177@bjmu.edu.cn",[55],{"facility":5,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Beijing","Beijing Municipality","Municipality 100034","China","CN",{"type":63,"coordinates":64},"Point",[65,66],116.39723,39.9075,{"lat":66,"lon":65},[69],{"name":5,"role":51,"phone":70,"phoneExt":25,"email":71},"+86 010-83576401","bdyyll@126.com",{"type":47,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Meng LIU","Chief Physician","100653998","gpc3-targeted-pet-imaging-of-18f-x12-in-hepatocellular-carcinoma-100653998",false,"NCT07795437","GPC3-Targeted PET Imaging of 18F-X12 in Hepatocellular Carcinoma","Clinical Study of Glypican-3 (GPC3)-Targeted Novel Probe 18F-X12 for the Diagnosis of Hepatocellular Carcinoma (HCC)","Inclusion Criteria:\n\n* Patients aged ≥ 18 years old.\n* Patients fully understand the trial requirements, participate in the study voluntarily, and provide written informed consent.\n* Meet either of the following two conditions:\n* Patients with highly suspected hepatocellular carcinoma (HCC) (hepatic space-occupying lesion of undetermined nature on imaging examination) or pathologically confirmed HCC, with no prior systemic therapy (including immunotherapy, chemoradiotherapy, targeted therapy, etc.) or suspected tumor recurrence after previous treatment, and able to independently cooperate with relevant examinations.\n* Patients with clinically diagnosed HCC who have received 18F-FDG positron emission tomography\u002Fcomputed tomography (PET\u002FCT) for clinical staging or post-treatment restaging, and able to independently cooperate with relevant examinations.\n\nExclusion Criteria:\n\n* Patients with severe non-malignant diseases that may interfere with study objectives, or impair subject safety and study compliance, including but not limited to psychiatric disorders, infectious diseases, autoimmune diseases, and metabolic diseases.\n* Pregnant or lactating females.\n* Subjects who are unable to understand the examination procedure or cannot cooperate with trial-related examinations and operations.",true,"ALL","18 Years",{"count":86,"type":87},100,"ESTIMATED","INTERVENTIONAL",[27],"This is a diagnostic study. This clinical trial aims to evaluate the diagnostic performance and safety of the novel radiotracer 18F-X12 in patients with hepatocellular carcinoma (HCC), and to provide evidence supporting a new approach for its early diagnosis, accurate staging and recurrence assessment.",[92],"Hepatocellular Carcinoma (HCC)","2026-08-29",{"date":95,"type":96},"2026-09-02","ACTUAL",{"date":98,"type":96},"2026-08-25",{"date":100,"type":87},"2029-08-30",{"name":5,"class":6},1]