[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586512":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":18,"locations":24,"responsibleParty":38,"collaborators":40,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":10,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":10,"overallStatus":26,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"The Affiliated Hospital of Qingdao University","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"18F-FAPI-04 PET scan",null,[12],"Radiation: 18F-FAPI-04 PET scan",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":10},"RADIATION","FAPI-04, labeled with PET radio-nuclide 18F will be used as a molecular imaging tracer for PET scan. All participants will undergo 18F-FAPI-04 PET scan.",[9],[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Zhenguang Wang","CONTACT","＋86-0532-82913318","wangzhenguang@qde.edu.cn",[25],{"facility":5,"status":26,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":10},"RECRUITING","Qingdao","Shandong","266000","China","CN",{"type":33,"coordinates":34},"Point",[35,36],120.38042,36.06488,{"lat":36,"lon":35},{"type":39,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[41,43,46,48],{"name":42,"class":6},"Weifang People's Hospital",{"name":44,"class":45},"Zibo Central Hospital","OTHER_GOV",{"name":47,"class":6},"Qianfoshan Hospital",{"name":49,"class":6},"Jining Medical University","100586512","clinical-study-of-18f-labeled-fapi-04-in-pet-imaging-of-breast-cancer-100586512",false,"NCT06916338","Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer","Inclusion Criteria:\n\n1. Age 18-75 years old, any gender;\n2. Clinically or pathologically confirmed diagnosis of breast cancer, or suspected recurrence\u002Fmetastasis;\n3. Presence of at least 1 measurable lesion (RECIST 1.1 criteria);\n4. ECOG score 0-2 and expected survival ≥ 12 weeks;\n5. Laboratory markers are met:\n\n   Blood count: WBC ≥4.0×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90 g\u002FL Liver and kidney function: ALT\u002FAST ≤ 2.5 × ULN, SCr ≤ 1.5 × ULN;\n6. Signed informed consent.\n\nExclusion Criteria:\n\n1. Major surgery or trauma within 4 weeks;\n2. Severe infection, liver or kidney insufficiency;\n3. History of allergies (developer components);\n4. Pregnant\u002Fnursing female or not using effective contraception;\n5. Inability to co-operate with PET (e.g. claustrophobia);\n6. Any other situation that researchers considered it unsuitable to participate in the trial.","ALL","18 Years","75 Years",{"count":60,"type":61},30,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the diagnostic accuracy (sensitivity, specificity, positive\u002Fnegative predictive value, and overall accuracy) of 18F-FAPI-04 PET imaging in breast cancer for detecting fibroblast activation protein (FAP)-rich lesions. Additionally, the study will longitudinally monitor dynamic changes in FAP expression levels and tumor size during therapy, including chemotherapy, targeted therapy, or immunotherapy.The non-invasive nature of 18F-FAPI-04 PET addresses limitations of traditional biopsy-dependent stromal evaluation, offering whole-body quantification of tumor microenvironment dynamics to optimize therapeutic decision-making.",[65],"Breast Cancer","2025-04-27",{"date":68,"type":69},"2025-04-29","ACTUAL",{"date":71,"type":69},"2025-04-11",{"date":73,"type":61},"2027-12",{"name":5,"class":6},1]