[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571036":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":55,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Diagnostic Validation Cohort","EXPERIMENTAL","Patients with newly diagnosed or suspected breast cancer will undergo one \\[68Ga\\]Ga-TTP scan and one \\[18F\\]FDG scan within 1 week, in randomized order, with no anticancer treatment administered between the two imaging examinations. This cohort is used to evaluate tumor targeting, compare diagnostic performance with \\[18F\\]FDG, and correlate imaging findings with pathology and TROP2 expression.",[13,14],"Drug: 18F-FDG","Drug: [68Ga]Ga-TTP",{"label":16,"type":10,"description":17,"interventionNames":18},"ADC Response Assessment Cohort","Patients with breast cancer who are planned to receive TROP2-directed ADC therapy will undergo paired \\[68Ga\\]Ga-TTP and \\[18F\\]FDG imaging at three time points: before treatment, after 2 cycles of ADC therapy(each cycle is 21 days), and at disease progression. This cohort is used to assess longitudinal imaging changes and their relationship with treatment response.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","18F-FDG","\\[18F\\]FDG is administered intravenously as the comparator PET radiotracer. In the diagnostic validation cohort, participants undergo one \\[18F\\]FDG PET examination within 1 week of the \\[68Ga\\]Ga-TTP scan, with no treatment between scans. In the ADC response assessment cohort, participants undergo \\[18F\\]FDG PET imaging at the same three time points as \\[68Ga\\]Ga-TTP: before ADC therapy, after 2 cycles(each cycle is 21 days), and at disease progression. The planned administered activity is approximately 0.1-0.15 mCi\u002Fkg.",[16,9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"[68Ga]Ga-TTP","\\[68Ga\\]Ga-TTP is a TROP2-targeted PET radiotracer administered intravenously for PET imaging. In the diagnostic validation cohort, participants undergo one \\[68Ga\\]Ga-TTP PET examination within 1 week of the comparator \\[18F\\]FDG scan. In the ADC response assessment cohort, participants undergo \\[68Ga\\]Ga-TTP PET imaging before ADC therapy, after 2 cycles of treatment(each cycle is 21 days), and at disease progression. The planned administered activity is approximately 0.05-0.1 mCi\u002Fkg.",[16,9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Zhi Yang","CONTACT","010-88196196","pekyz@163.com",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Guojun Zhang","0871-68231187","zhangguojun@kmmu.edu.cn;",[41],{"facility":5,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Beijing","100143","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Hua Zhu","Associate Professor",[60],{"name":61,"class":6},"Yunnan Cancer Hospital","100571036","establishment-and-clinical-transformation-of-adc-drug-efficacy-evaluation-system-for-breast-cancer-based-on-molecular-imaging-100571036",false,"NCT06715020","Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging","Inclusion Criteria:\n\n1. Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);\n2. Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 \u002FL, PLT ≥ 100×109\u002FL, Hb≥ 90 g\u002FL; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;\n3. Patients with confirmed or suspected breast cancer;\n4. Expected survival ≥12 weeks;\n5. Good follow-up compliance;\n6. Women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination;\n7. Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.\n\nExclusion Criteria:\n\n1. Severe abnormal liver and kidney function;\n2. Pregnant, pregnant and lactating women;\n3. Can not lie flat for half an hour;\n4. Unable to obtain informed consent;\n5. Suffering from claustrophobia or other mental illness;\n6. People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;\n7. Other conditions deemed unsuitable for participation in the trial by the investigator.","ALL","18 Years","75 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"NA","The objective of the study is to construct a noninvasive approach 68Ga-TTP PET\u002FCT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy.",[79],"Breast Cancer","2026-05-28",{"date":82,"type":83},"2026-06-02","ACTUAL",{"date":85,"type":83},"2024-12-10",{"date":87,"type":73},"2026-12",{"name":5,"class":6},1]