Pilot Study of 18FF-GLN PETCT Imaging in Breast Cancer Evaluating Uptake and Safety in Primary and Metastatic Tumors

What this Trial Is About

This research aims to evaluate the uptake of the imaging agent 18FF-GLN in patients with known or suspected primary or metastatic breast cancer who have at least one lesion 1.0 cm or larger. Up to 40 patients will participate, including at least 10 with estrogen-receptor-expressing breast cancer and 10 with triple-negative breast cancer. Participants may be new to treatment or have received up to three weeks of therapy at the time of the imaging scan. This is an observational study where imaging results do not guide treatment decisions, which remain based on clinical judgment. Participants will undergo approximately 60 minutes of dynamic PET scanning after injection of 18FF-GLN, followed by up to two static scans from skull base to mid-thigh. A baseline FDG-PETCT scan will also be performed, either as part of routine care or research. Some participants undergoing systemic therapy may have a second 18FF-GLN PETCT and possibly a second FDG-PETCT to explore changes in uptake related to treatment. Additional low-dose CT scans may be done if motion occurs during imaging. Throughout the study, metabolism data and image quality will be collected, along with preliminary information on 18FF-GLN uptake in breast cancer. Uptake will be compared to tumor markers of glutamine metabolism when tissue is available. Safety of 18FF-GLN will be monitored in all participants. The primary outcome is to assess the kinetics and biodistribution of 18FF-GLN, with secondary outcomes including safety, associations with tumor markers, metabolism, and changes after therapy, over a three-year period.

[18F] F-GLN by PET/CT in Breast Cancer