[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570566":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":17,"responsibleParty":32,"collaborators":34,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":7,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":7,"enrollmentInfo":49,"targetDuration":52,"studyType":53,"phases":7,"briefSummary":54,"conditions":55,"keywords":7,"overallStatus":20,"whyStopped":7,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},{"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,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"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","DE",{"type":27,"coordinates":28},"Point",[29,30],6.77927,51.22319,{"lat":30,"lon":29},{"type":33,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[35,37],{"name":36,"class":6},"University Hospital, Essen",{"name":38,"class":39},"Marienhospital Bottrop","UNKNOWN","100570566","ai-based-pcr-assessmentprediction-in-her2-positive-bc-using-petmri-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":50,"type":51},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",[56],"HER2 Positive Breast Carcinoma","2025-09-23",{"date":59,"type":60},"2025-09-24","ACTUAL",{"date":62,"type":60},"2025-07-18",{"date":64,"type":51},"2031-07",{"name":5,"class":6},1]