[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570566":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":17,"responsibleParty":31,"collaborators":33,"id":39,"slug":7,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":7,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":7,"enrollmentInfo":47,"targetDuration":50,"studyType":51,"phases":7,"briefSummary":52,"conditions":53,"keywords":7,"overallStatus":20,"whyStopped":7,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},{"fullName":5,"class":6},"Heinrich-Heine University, Duesseldorf","OTHER",null,[9,14],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"PD Dr. med. Kirchner","CONTACT","+492118117552","Julian.Kirchner@med.uni-duesseldorf.de",{"name":15,"role":11,"phone":12,"phoneExt":7,"email":16},"Dr. med. Jannusch","kai.jannusch@med.uni-duesseldorf.de",[18],{"facility":19,"status":20,"city":21,"state":22,"zip":23,"country":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":7},"Department of Diagnostic and Interventional Radiology, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf","RECRUITING","Düsseldorf","North Rhine-Westphalia","40225","Germany",{"type":26,"coordinates":27},"Point",[28,29],6.77927,51.22319,{"lat":29,"lon":28},{"type":32,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[34,36],{"name":35,"class":6},"University Hospital, Essen",{"name":37,"class":38},"Marienhospital Bottrop","UNKNOWN","100570566",false,"NCT06708910","AI-based pCR Assessment\u002FPrediction in HER2-Positive BC Using PET\u002FMRI","Multiparametric 18F-FDG PET\u002FMRI for Assessment and Prediction of Locoregional Therapy Response in HER2-positive Breast Cancer Patients Using Artificial Intelligence","Inclusion Criteria:\n\n* Female\n* HER2-positive breast carcinoma\n* legally competent female patients aged ≥ 18 years\n* willing and able to attend scheduled examinations\n* written informed consent for study participation\n* decision to receive neoadjuvant systemic therapy \u002F exclusion of distant metastases\n\nExclusion Criteria:\n\n* previous cancer diagnosis within the last five years or second, synchronous malignancy\n* contraindication to MRI examination\n* severe renal insufficiency\n* pregnancy or lactation","FEMALE","18 Years",{"count":48,"type":49},460,"ESTIMATED","15 Weeks","OBSERVATIONAL","Goal of the observational study: Based on PET\u002FMRI data it is possible to differentiate between complete and incomplete pathological remission after neoadjuvant systemic therapy in HER2-positive breast cancer patients.\n\nThe main question it aims to answer are:\n\nPrimary endpoint:\n\n1\\) Sensitivity and specificity as co-primary endpoints for identification of HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET\u002FMRI (response assessment)\n\nSecondary endpoint(s):\n\n1. Accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET\u002FMRI (response assessment)\n2. Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of the primary (yT0) after neoadjuvant therapy using 18F-FDG PET\u002FMRI (response assessment)\n3. Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of locoregional lymph node metastases (yN0) after neoadjuvant therapy using 18F-FDG PET\u002FMRI (response assessment)\n4. Evaluation of pre-treatment (baseline) 18F-FDG PET\u002FMRI for predicting therapy response of the primary and locoregional lymph node metastases in patients with HER2-positive breast carcinoma supported by artificial-intelligence (prediction)\n5. Evaluation of 18F-FDG PET\u002FMRI for predicting therapy response of the primary in patients with HER2-positive breast carcinoma after the first cycles of systemic therapy supported by artificial-intelligence (prediction)\n6. Evaluation of 18F-FDG PET\u002FMRI for predicting therapy response of locoregional lymph node metastases in patients with HER2-positive breast carcinoma after the first cycles of system therapy supported by artificial-intelligence (prediction)\n\nThe guideline-recommended staging procedure (S3 Germany) using CT will be replaced by a whole-body 18F-FDG PET\u002FMRI, including dedicated 18F-FDG PET\u002FMRI of the breast. The histopathologic results of tissue samples obtained during routine clinical treatment after successful neoadjuvant systemic therapy will serve as a reference standard.\n\nThe study protocol involves the following examinations for all included patients:\n\n1. Baseline (pre-treatment) examination to substitute for the staging examinations specified in the S3 guideline: Initial whole-body 18F-FDG PET\u002FMRI including 18F-FDG PET\u002FMRI of the breast\n2. Thoracic 18F-FDG PET\u002FMRI including 18F-FDG PET\u002FMRI of the breast after the first two cycles of systemic therapy\n3. Thoracic 18F-FDG PET\u002FMRI including 18F-FDG PET\u002FMRI of the breast after completion of systemic therapy and immediately before clinically indicated surgery",[54],"HER2 Positive Breast Carcinoma","2025-09-23",{"date":57,"type":58},"2025-09-24","ACTUAL",{"date":60,"type":58},"2025-07-18",{"date":62,"type":49},"2031-07",{"name":5,"class":6},1]