About this trial
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
Qualifiers
Male or female patients aged ≥19 years, regardless of race/ethnicity
Patients newly diagnosed with invasive breast cancer within 90 days prior to screening, with documented histopathological confirmation.
Patients diagnosed with histologically confirmed estrogen receptor-positive, histologic grade 1 or 2 primary breast cancer
Patients with clinical stage IIIA-IIIC disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system
Disqualifiers
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., neoadjuvant chemotherapy, hormonal therapy)
Subjects with a history of another invasive malignancy within the past 2 years (except for non-melanoma skin cancer)
Subjects diagnosed with distant metastases on chest CT, abdominal CT, or bone scintigraphy performed within 90 days prior to screening or before the 18F-FES PET/CT scan
Trial design
Treatments tested in this trial
- Fluoroestradiol (18F)