Phase II Study of 18F-FES PETMRI Imaging to Guide Treatment for Luminal A and Lobular Breast Cancer Evaluating Accuracy in Axillary Lymph Node Staging Compared to Surgery

What this Trial Is About

Researchers are studying patients with Luminal A and estrogen receptor-positive ER-positive lobular breast cancer to evaluate a new imaging method. This study aims to assess the use of hybrid PETMRI combined with a radiolabeled form of estrogen called 16-alpha-18F-fluoro-17-beta-estradiol FES for accurate, non-invasive staging of these breast cancers. The study focuses on comparing this imaging techniques ability to detect cancer spread in axillary lymph nodes with the results from axillary surgery. Participants will undergo a single cohort study where they receive primary surgery as their first treatment. Before surgery, they will have an FES PETMRI scan using the radiotracer FES to capture detailed images of their cancer. Selected patients with heterogeneous tumors on imaging will also have further analysis through pathology, imaging, genomic, and radiomic studies to explore tumor characteristics. Throughout the study, participants will be monitored for the sensitivity of the FES PETMRI in detecting axillary lymph node metastases. Researchers will collect imaging data before surgery and compare it with surgical findings. The study involves no masking or placebo and will follow patients from enrollment until after surgery to gather diagnostic performance data. The total study period extends until 2029, with primary outcome assessment planned around 50 days after imaging.

18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer