[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633201":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":20,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":20,"enrollmentInfo":38,"targetDuration":20,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":47,"overallStatus":52,"whyStopped":20,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":20},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"68Ga-FAP-2286 PET\u002FCT Imaging","EXPERIMENTAL","Patients undergo intravenous administration (200 MBq) of 68Ga-FAP-2286 followed by PET\u002FCT imaging for staging of high-risk primary breast cancer. A baseline scan is performed prior to initiation of therapy. Patients receiving neoadjuvant chemotherapy undergo an additional scan prior to surgery.",[13],"Drug: 68Ga-FAP-2286",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","68Ga-FAP-2286","One scan at baseline staging, and for those reciving NACT : one scan before surgery.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Sara E Dahlsgaard-Wallenius, MD","CONTACT","+45 53 57 45 55","sara.elisabeth.wallenius@rsyd.dk",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100633201","phase-2-fap-petct-for-staging-patients-with-breast-cancer-100633201",false,"NCT07523607","FAP PET\u002FCT for Staging Patients With Breast Cancer","[⁶⁸Ga]Ga-FAP-2286 PET\u002FCT for Staging and Restaging Patients With Newly Diagnosed Primary Breast Cancer: a Phase II Study (FAPILOUS)","Inclusion Criteria:\n\n* Male and females ≥ 18 years\n* Biopsy-verified newly diagnosed breast cancer\n* Can read and understand Danish\n* Capable of providing written and informed consent\n* Undergoing a routine \\[¹⁸F\\]FDG PET\u002FCT scan as part of the clinical standard diagnostic workup\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Not able to participate in the conduct of the scan due to any reason ( e.g., claustrophobia or inability to lie still for entire imaging time)\n* Ongoing oncological treatment for another cancer\n* History of allergic reactions \u002F hypersensitivity attributed to \\[⁶⁸Ga\\]Ga-FAP-2286.","ALL","18 Years",{"count":39,"type":40},65,"ESTIMATED","INTERVENTIONAL",[43],"PHASE2","This study aims to evaluate the clinical utility of \\[68Ga\\]Ga-FAP-2268 PET\u002FCT for disease staging and assessment in patients with high-risk primary breast cancer. By targeting fibroblast activation protein (FAP), this novel imaging approach may offer improved tumor visualization compared to conventional imaging, which may help improve treatment planning.",[46],"Breast Cancer Detection",[48,49,50,51],"Breast cancer","PET\u002FCT","FAP","FAPI","NOT_YET_RECRUITING","2026-04-08",{"date":55,"type":56},"2026-04-13","ACTUAL",{"date":58,"type":40},"2026-06-01",{"date":60,"type":40},"2029-01",{"name":5,"class":6}]