Breast Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TEST68Ga-FAPI PET/CT scan
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age 18-80 years old; * newly diagnosed BC confirmed by biopsy or with BI-RADS category 4C or 5 lesions by US or MG; * BC clinical stagecT1-3 cN0-3 M0; * no prior treatment for BC.
Exclusion criteria
* pregnancy; * breastfeeding; * patients who were unwilling to undergo PET/CT scans.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance (1) | Through study completion, an average of 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Stage | Through study completion, an average of 1 year | Clinical stage changed by 68Ga-FAPI PET/CT compared to 18F-FDG PET/CT. |
| Diagnostic Performance (2) | Through study completion, an average of 1 year | Diagnostic performance of ALN metastasis of 68Ga-FAPI PET/CT with or without previous biopsy on breast lesion. |
| Safety | Through study completion, an average of 1 year | Short-term adverse effects (AEs) after 68Ga-FAPI injection. |
Countries
China
Outcome results
None listed