Project Details
Projekt
Multiparametric 18F-FDG PET/MRI for assessment and prediction of locoregional therapy response in HER2-positive breast cancer patients using artificial intelligence
Applicant
Privatdozent Dr. Julian Kirchner
Subject Area
Radiology
Term
since 2024
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 533909315
In the current recommendation of the Working Group of Gynecologic Oncology, neoadjuvant systemic therapy (NAST) with a pertuzumab/trastuzumab-based regimen followed by surgery is recommended for HER2-positive breast cancer patients with a cT ≤ 2 or axillary lymph node involvement (N+) detected on fine-needle biopsy. The aim of therapy is pathologic complete remission (pCR) of the primariy and lymph nodes. However, image-based detection of pCR is currently not possible with certainty, and according to a meta-analysis, the sensitivity is only 64%. Also, in the evaluation of axillary lymph nodes for pCR, no imaging has been established as an alternative to invasive procedures. Thus, breast surgery and histological confirmation of axillary lymph nodes after NAST is still required as a combination of therapy and staging. The use of artificial intelligence, with the aid of quantitative image features (radiomics) and machine learning, has provided a new basis for imaging-based, non-invasive tissue characterization. The primary endpoint of this study is the determination of 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. Secondary endpoints are (1) determination of accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI, (2) determination of 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, (3) determination of sensitivity, specificity and accuracy for the identification of patients with HER2- positive breast carcinoma with complete pathologic remission (pCR) of the locoregional lymph node metastases (yN0) after neoadjuvant therapy using 18F- FDG PET/MRI, (4) evaluation of 18F-FDG PET/MRI for predicting therapy response of the primary and locoregional lymph node metastases in patients with HER2-positive breast carcinoma in advance to therapy supported by artificial-intelligence, (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 , and (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.
DFG Programme
Clinical Trials
