[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571875":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":32,"responsibleParty":50,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study cohort",null,"Patient receiving 68Ga-GZMB PET\u002FCT",[13],"Device: 68Ga-GZMB PET\u002FCT",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","68Ga-GZMB PET\u002FCT",[9],[20],{"name":21,"affiliation":22,"role":23},"Xiaosong Chen","Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital","PRINCIPAL_INVESTIGATOR",[25,29],{"name":21,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+86-21-64370045-602102","chenxiaosong0156@hotmail.com",{"name":30,"role":26,"phone":27,"phoneExt":10,"email":31},"Siji Zhu","zsj_mu@yeah.net",[33],{"facility":22,"status":34,"city":35,"state":10,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Shanghai","200025","China","CN",{"type":40,"coordinates":41},"Point",[42,43],121.45806,31.22222,{"lat":43,"lon":42},[46,48,49],{"name":21,"role":26,"phone":27,"phoneExt":10,"email":47},"xiaosongchen0156@hotmail.com",{"name":30,"role":26,"phone":27,"phoneExt":10,"email":31},{"name":21,"role":23,"phone":10,"phoneExt":10,"email":10},{"type":23,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Kunwei Shen","Professor","100571875","gzmb-petct-to-evaluate-neoadjuvant-therapy-efficacy-in-breast-cancer-100571875",false,"NCT06725940","GzmB-PET\u002FCT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer","Clinical Study on the Evaluation of Neoadjuvant Therapy Efficacy in Breast Cancer Using PET\u002FCT With Granzyme B Imaging Probe","GzmB-PET4BC","Inclusion Criteria:\n\n* age 16-65\n* histologically confirmed unilateral primary invasive breast cancer\n* Tumor size≥2cm, axillary lymph node positive, treated with neoadjuvant therapy\n* complete clinical and histo-pathological information\n* ECOG 0-1 within 10 days from the beginning of the study\n* Normal Bone Marrow Reserve: White blood cell count ≥ 3.0×10\\^9\u002FL, Neutrophil count ≥ 1.5×10\\^9\u002FL, Hemoglobin level ≥ 90g\u002FL; Platelet count (PLT) ≥ 80×10\\^9\u002FL; Normal Liver and Kidney Function: Blood aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal, Total bilirubin ≤ 1.5 times the upper limit of normal, Serum creatinine ≤ 1.5 times the upper limit of normal, and Creatinine clearance rate \\> 50ml\u002Fmin.\n* The patient has good compliance with the planned treatment, understands the research procedures, and has signed a written informed consent form\n\nExclusion Criteria:\n\n* bilateral or metastatic (stage IV) breast cancer\n* There has been a history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer\n* Severe systemic infection or other uncontrolled diseases\n* Patients with psychiatric disorders or those unable to comply with treatment due to other reasons\n* Known allergy or intolerance to the drug or its excipients\n* Having received cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason in the past\n* Patients who are pregnant or lactating, as well as patients of reproductive age who refuse to take appropriate contraceptive measures during the course of this trial.\n* Patients deemed unsuitable for participation in this study by the investigator.","ALL","18 Years","65 Years",{"count":65,"type":66},50,"ESTIMATED","1 Year","OBSERVATIONAL","To explore the efficacy of 68Ga-GZMB PET\u002FCT in assessing the response to neoadjuvant therapy for breast cancer, and to investigate the optimal SUVmax threshold of 68Ga-GZMB PET\u002FCT for predicting pathological complete response (pCR), aiming to provide a new and effective means for accurately and non-invasively evaluating the efficacy of neoadjuvant therapy.",[71],"Breast Cancer Invasive",[73,74,75,76,77],"breast cancer","Granzyme B","PET\u002FCT","neoadjuvant treatment","pCR","2024-12-05",{"date":80,"type":81},"2024-12-10","ACTUAL",{"date":83,"type":81},"2024-11-01",{"date":85,"type":66},"2025-11-01",{"name":5,"class":6},1]