[18F]FES PET/CT for the Detection of Distant Metastasis in Low-grade ER-positive Stage III Breast Cancer

Recruiting now · Phase 2

Conditions studied: Stage III Breast Cancer

In brief

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.

Key facts

Study ID

NCT07314073

Run by

Asan Medical Center

People needed

85

Starts

2025-12-24

Expected to finish

2029-12-31

Last updated by the study team

2026-01-02

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤2

You may not qualify if…

• 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
• Subjects for whom neither biopsy nor ≥6 months of follow-up imaging has been performed for lesions suspicious for distant metastases
• Pregnant or breastfeeding women. The following cases are considered not at risk of pregnancy: (1) physiologically postmenopausal (no menses for ≥2 years), (2) surgically sterile (history of bilateral oophorectomy or hysterectomy), (3) women of childbearing potential with a documented negative serum or urine pregnancy test within 24 hours prior to 18F-FES administration, and who agree to use effective contraception during the trial.
• Subjects with serious and/or uncontrolled and/or unstable medical conditions (e.g., congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic kidney disease, or chronic liver disease)
• Subjects who are relatives or students of the investigator, or otherwise in a dependent relationship with the investigator
• Subjects who, in the judgment of the investigator, are unable to provide complete data for the clinical trial due to personal circumstances or other reasons

Where it is running

• Asan Medical Center — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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