Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitute a major proportion of cells within the tumor microenvironment, especially in breast cancer. 68Ga-FAPI has been developed as a tumor-targeting agent. This prospective study is going to investigate the performance and value of 68Ga-FAPI PET/CT in patients with breast cancer.
Breast cancer is a complex, heterogeneous disease comprising numerous distinct biological subtypes characterized by variant pathobiological features and clinical behaviors. 18F-fluorodeoxyglucose (18F-FDG) PET/CT, an essential imaging modality in the characterization of metabolism within the tumor, has successfully evolved in the diagnosis, staging, and assessment of treatment response in patients with breast cancer. Cancer-associated fibroblasts (CAFs) are a crucial component of the tumor stroma with diverse functions. Fibroblast activation protein (FAP), a type II membrane-bound glycoprotein from the dipeptidyl peptidase-4 family, is highly expressed in the CAFs of several epithelial carcinomas, including breast cancer, coupled with relatively low expression in normal tissue. Gallium-68 (68Ga)-conjugated FAP inhibitor (FAPI), a new radiotracer targeting FAP, has been developed for targeting FAP and tumor-stromal visualization. With its fast renal clearance and high tumor-to-background ratio, 68Ga-FAPI has been successfully validated in multi-types of tumors. This study aims to evaluate the performance and value of 68Ga- FAPI PET/CT in patients with breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
72
Patients with suspected breast cancer underwent 68Ga-FAPI PET/CT after an injection of 74-148 MBq (2-4 mCi) 68Ga-FAPI to image lesions of breast cancer.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Diagnostic Performance (1)
Diagnostic performance including sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 68Ga-FAPI PET/CT in the detection of ALN metastasis according to the pathological reference standard on a per-patient basis, compared with 18F-FDG PET/CT and ultrasound.
Time frame: Through study completion, an average of 1 year
Clinical Stage
Clinical stage changed by 68Ga-FAPI PET/CT compared to 18F-FDG PET/CT.
Time frame: Through study completion, an average of 1 year
Diagnostic Performance (2)
Diagnostic performance of ALN metastasis of 68Ga-FAPI PET/CT with or without previous biopsy on breast lesion.
Time frame: Through study completion, an average of 1 year
Safety
Short-term adverse effects (AEs) after 68Ga-FAPI injection.
Time frame: Through study completion, an average of 1 year
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