NCT07314073 [18F]FES PET/CT for the Detection of Distant Metastasis in Low-grade ER-positive Stage III Breast Cancer
| NCT ID | NCT07314073 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Asan Medical Center |
| Condition | Stage III Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2025-12-24 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 85 participants in total. It began in 2025-12-24 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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., 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
Contact & Investigator
Hyehyun Jeong
PRINCIPAL INVESTIGATOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT07314073 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Stage III Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07314073 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07314073 currently recruiting?
Yes, NCT07314073 is actively recruiting participants. Contact the research team at hswon87@amc.seoul.kr for enrollment information.
Where is the NCT07314073 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07314073 clinical trial?
NCT07314073 is sponsored by Asan Medical Center. The principal investigator is Hyehyun Jeong at Asan Medical Center. The trial plans to enroll 85 participants.
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