What this Trial Is About

Researchers are evaluating glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) using PET imaging in women diagnosed with breast cancer. This study focuses on patients with newly diagnosed, node-positive invasive breast cancer who are referred for diagnostic imaging before starting primary therapy. The study aims to compare the PET/CT positivity rates of 68Ga-FAPi and the standard 18F-FDG imaging agent across different breast cancer subtypes. Participants will undergo baseline diagnostic imaging with 18F-FDG PET/CT as part of their routine work-up. Eligible patients will then receive 68Ga-FAPi-46 PET/CT imaging within four weeks of the 18F-FDG scan and prior to primary treatment, which may include surgery or neo-adjuvant therapy. The 68Ga-FAPi-46 PET/CT is a non-interventional, open-label procedure used to assess tumor micro-environment characteristics. During the study, women will be monitored through these imaging assessments and evaluated for the uptake of both imaging agents over a three-month period. Eligibility and clinical status will be reviewed by a nuclear medicine physician. Researchers will measure and compare the positivity rates of 68Ga-FAPi PET/CT and 18F-FDG PET/CT to better understand imaging agent expression related to breast cancer. Enrollment is expected to be completed within 12 months, with informed consent obtained prior to participation.

Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer