Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer

This study aims to evaluate the diagnostic accuracy (sensitivity, specificity, positive/negative predictive value, and overall accuracy) of 18F-FAPI-04 PET imaging in breast cancer for detecting fibroblast activation protein (FAP)-rich lesions. Additionally, the study will longitudinally monitor dynamic changes in FAP expression levels and tumor size during therapy, including chemotherapy, targeted therapy, or immunotherapy.The non-invasive nature of 18F-FAPI-04 PET addresses limitations of traditional biopsy-dependent stromal evaluation, offering whole-body quantification of tumor microenvironment dynamics to optimize therapeutic decision-making.

NCT Number	NCT06916338
Lead Sponsor	The Affiliated Hospital of Qingdao University Collaborators: Weifang People's Hospital, Zibo Central Hospital, Qianfoshan Hospital, Jining Medical University
Conditions	Breast Cancer
Enrollment	30 participants
Start Date	2025-04-11
Primary Completion	2026-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2025-04-29