Pilot Study Evaluating the Uptake of [18F] F-GLN by PET/CT in Breast Cancer

What this Trial Is About

This research aims to evaluate the uptake of the imaging agent [18F]F-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 [18F]F-GLN, followed by up to two static scans from skull base to mid-thigh. A baseline FDG-PET/CT scan will also be performed, either as part of routine care or research. Some participants undergoing systemic therapy may have a second [18F]F-GLN PET/CT and possibly a second FDG-PET/CT 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 [18F]F-GLN uptake in breast cancer. Uptake will be compared to tumor markers of glutamine metabolism when tissue is available. Safety of [18F]F-GLN will be monitored in all participants. The primary outcome is to assess the kinetics and biodistribution of [18F]F-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