Accuracy and Safety of 68Ga-FAPI PET/CT in the Diagnosis of Axillary Lymph Node Metastasis in Early Breast Cancer Patients: A Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Diagnostic Performance (1)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
68Ga-FAPI PET/CT
Inject 68Ga-FAPI and then perform PET/CT scan.
Intervention: 68Ga-FAPI PET/CT scan (Diagnostic Test)
Outcomes
Primary Outcomes
Diagnostic Performance (1)
Time Frame: 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 Outcomes
- Clinical Stage(Through study completion, an average of 1 year)
- Diagnostic Performance (2)(Through study completion, an average of 1 year)
- Safety(Through study completion, an average of 1 year)