[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576820":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":45,"collaborators":18,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":18,"enrollmentInfo":57,"targetDuration":18,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"68Ga-FAPi-46 PET\u002FCT","EXPERIMENTAL","Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET\u002FCT",[13],"Procedure: 68Ga-FAPi-46 PET\u002FCT",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"PROCEDURE",[9],null,[20],{"name":21,"affiliation":22,"role":23},"Francesco Ceci, MD","European Istitute of Oncology","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Francesco Ceci","CONTACT","+390257489315","francesco.ceci@ieo.it",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":34,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Milan","Italy","20141","IT",{"type":38,"coordinates":39},"Point",[40,41],9.18951,45.46427,{"lat":41,"lon":40},[44],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},{"type":46,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100576820","exploring-the-tumor-micro-environment-with-68ga-fapi-46-petct-in-breast-cancer-100576820",false,"NCT06790264","Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET\u002FCT in Breast Cancer","Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET\u002FCT in Breast Cancer. a Phase II Study to Evaluate the Comparison of 68Ga-FAPi-46 and 18F-FDG Uptake in Patients with Different Breast Cancer Subtypes","FAPI-PET","Inclusion Criteria:\n\n* Newly diagnosed, biopsy proven breast cancer;\n* Diagnosis of invasive breast cancer;\n* Tumor diameter more than 2 centimeters;\n* Radiological evidence of axillary nodes involvement;\n* 18F-FDG PET\u002FCT performed as baseline diagnostic procedure, during routine diagnostic work-up;\n* 68Ga-FAPi-46 PET\u002FCT performed within 4 weeks from 18F-FDG PET\u002FCT;\n* Patients suitable to primary treatment (surgery or neo-adjuvant therapy);\n* 68Ga-FAPi-46 PET\u002FCT performed within 8 weeks from primary treatment;\n* Female patients;\n* Age ≥18;\n* Willing to sign informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or nursing patients;\n* Unable to stay flat and cannot tolerate PET scan;\n* Sample tissue from biopsy unavailable for assessing Fibroblast Activation Protein (FAP) expression;\n* Eastern Cooperative Oncology Group (ECOG) performance status ≥2.","FEMALE","18 Years",{"count":58,"type":59},92,"ESTIMATED","INTERVENTIONAL",[62],"NA","This study is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) with PET imaging, in woman affected by Breast Cancer (BC) and referred to diagnostic imaging work-up prior to primary therapy.",[65,66],"Breast Cancer Invasive","Node Positive Breast Cancer",[9],"2025-01-23",{"date":70,"type":71},"2025-01-27","ACTUAL",{"date":73,"type":71},"2024-11-01",{"date":75,"type":59},"2025-11",{"name":5,"class":6},1]