ai-based pcr assessment/prediction in her2-positive bc using pet/mri

Conditions: HER2 Positive Breast Carcinoma

Summary: goal of the observational study: based on pet/mri data it is possible to differentiate between complete and incomplete pathological remission after neoadjuvant systemic therapy in her2-positive breast cancer patients. the main question it aims to answer are: primary endpoint: 1) 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/mri (response assessment) secondary endpoint(s): 1. accuracy for the identification of patients with her2-positive breast carcinoma with complete pathologic remission (pcr; yt0 yn0) using 18f-fdg pet/mri (response assessment) 2. 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/mri (response assessment) 3. 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/mri (response assessment) 4. evaluation of pre-treatment (baseline) 18f-fdg pet/mri for predicting therapy response of the primary and locoregional lymph node metastases in patients with her2-positive breast carcinoma supported by artificial-intelligence (prediction) 5. evaluation of 18f-fdg pet/mri 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) 6. evaluation of 18f-fdg pet/mri 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) the guideline-recommended staging procedure (s3 germany) using ct will be replaced by a whole-body 18f-fdg pet/mri, including dedicated 18f-fdg pet/mri 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. the study protocol involves the following examinations for all included patients: 1. baseline (pre-treatment) examination to substitute for the staging examinations specified in the s3 guideline: initial whole-body 18f-fdg pet/mri including 18f-fdg pet/mri of the breast 2. thoracic 18f-fdg pet/mri including 18f-fdg pet/mri of the breast after the first two cycles of systemic therapy 3. thoracic 18f-fdg pet/mri including 18f-fdg pet/mri of the breast after completion of systemic therapy and immediately before clinically indicated surgery


Eligibility criteria:
inclusion criteria: * female * her2-positive breast carcinoma * legally competent female patients aged ≥ 18 years * willing and able to attend scheduled examinations * written informed consent for study participation * decision to receive neoadjuvant systemic therapy / exclusion of distant metastases exclusion criteria: * previous cancer diagnosis within the last five years or second, synchronous malignancy * contraindication to mri examination * severe renal insufficiency * pregnancy or lactation