[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541838":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":46,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":19,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":19,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Maastricht University Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Additional 68Ga-FAPI-46 PET\u002FCT and PET\u002FMRI exam","EXPERIMENTAL","All participating patients will undergo an additional 68Ga-FAPI- 46 PET\u002FCT and 68Ga-FAPI-46 PET\u002FMRI scan prior to their breast cancer treatment.",[13],"Diagnostic Test: 68Ga-FAPI-46 PET\u002FCT and 68Ga-FAPI-46 PET\u002FMRI",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DIAGNOSTIC_TEST","68Ga-FAPI-46 PET\u002FCT and 68Ga-FAPI-46 PET\u002FMRI",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Thiemo JA van Nijnatten, MD, PhD","CONTACT","+31433876910","thiemo.nijnatten@mumc.nl",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Lisa EHW Duijx, MSc","+31639289798","lisa.duijx@mumc.nl",[31],{"facility":32,"status":33,"city":34,"state":19,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Maastricht University Medical Center+","RECRUITING","Maastricht","5800","Netherlands","NL",{"type":39,"coordinates":40},"Point",[41,42],5.68889,50.84833,{"lat":42,"lon":41},[45],{"name":22,"role":23,"phone":19,"phoneExt":19,"email":25},{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100541838","phase-2-18f-fdg-versus-68ga-fapi-46-as-pet-tracer-in-er-positive-breast-cancer-100541838",false,"NCT06335069","18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.","18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer - a Pilot Study.","Inclusion Criteria:\n\n* Female patient with histopathologically proven ER+ breast cancer.\n* Diagnosed with locally advanced (primary tumor \\>5 cm and\u002For presence of axillary lymph node metastases) or recurrent breast cancer, or metastatic breast cancer for which 18F-FDG PET\u002FCT or 18F-FDG PET\u002FMRI staging is performed.\n* Willing and able to undergo the study procedures.\n* Has personally provided written informed consent.\n\nExclusion Criteria:\n\n* Age \\\u003C18\n* Pregnancy\n* Patients with secondary malignancies (except non-melanoma skin cancer)\n* No 18F-FDG PET\u002FCT or 18F-FDG PET\u002FMRI scan.\n* Contra-indications for PET\u002FMRI such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia, and severe obesity\n* Chronic inflammatory disease such as rheumatoid arthritis.\n* Patients with severe hepatic or renal impairment (eGFR ≤45mL\u002Fmin\u002F1.73m²)\n* Inability to provide informed consent.","FEMALE","18 Years",{"count":58,"type":59},20,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET\u002FCT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET\u002FCT to have a higher detection rate compared to 18F-FDG PET\u002FCT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients.",[65,66,67],"Breast Cancer","Breast Neoplasms","Breast Diseases",[69,70,71,72],"68Ga-FAPI-46","ER+ breast cancer","PET\u002FCT","PET\u002FMRI","2025-09-19",{"date":75,"type":76},"2025-09-24","ACTUAL",{"date":78,"type":76},"2025-09-01",{"date":80,"type":59},"2027-03",{"name":5,"class":6},1]