[18F]FES PET/CT for the Detection of Distant Metastasis in Low-grade ER-positive Stage III Breast Cancer
Trial Parameters
Brief Summary
This study aims to evaluate the detection rate of distant metastases using \[18F\]FES PET/CT in patients with low-grade, ER-positive stage III breast cancer.
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients aged ≥19 years, regardless of race/ethnicity 2. Patients newly diagnosed with invasive breast cancer within 90 days prior to screening, with documented histopathological confirmation. 3. Patients diagnosed with histologically confirmed estrogen receptor-positive, histologic grade 1 or 2 primary breast cancer 4. Patients with clinical stage IIIA-IIIC disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system 5. Patients who have undergone, or are scheduled to undergo chest computed tomography (CT), abdominal CT, and bone scintigraphy within 90 days prior to screening before the 18F-FES PET/CT scan 6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤2 Exclusion Criteria: * The subject or the subject's legally authorized representative has not signed the informed consent form * Subjects who are currently receiving systemic therapy for breast cancer (e.g.