Actively Recruiting
A Phase 2, Open-label, Non-randomized Study Evaluating 18F-Fluoroestradiol PET/CT for Detecting Distant Metastases in Low-grade Estrogen Receptor-positive Stage III Breast Cancer
Led by Asan Medical Center · Updated on 2026-01-02
85
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 18F-fluoroestradiol (18F-FES) PET/CT imaging to detect distant metastases in patients with low-grade, estrogen receptor-positive stage III breast cancer. This study focuses on improving detection in this subgroup where current imaging methods like 18F-FDG PET/CT have limitations, especially in invasive lobular carcinoma and low-grade tumors. The trial aims to better understand the accuracy and clinical impact of 18F-FES PET/CT in this setting. Participants will undergo 18F-FES PET/CT scans to visualize estrogen receptor expression and detect metastatic disease. The study will compare 18F-FES PET/CT results to standard imaging methods, including 18F-FDG PET/CT, CT scans, and bone scintigraphy, assessing detection rates, sensitivity, specificity, and changes in clinical management. Imaging interpretation occurs within one week after scan acquisition, prior to definitive treatment, with follow-up assessments up to six months. During the study, participants will have baseline and follow-up imaging tests, including chest and abdominal CT, bone scans, and PET/CT scans. Researchers will evaluate how well 18F-FES PET/CT detects distant and lymph node metastases, and whether it influences treatment decisions like surgery or radiotherapy planning. Patient health status and safety will be monitored throughout, with clinical management decisions reviewed up to four weeks after imaging. Total participation duration varies by individual based on follow-up needs.
CONDITIONS
Brief Title
[18F]FES PET/CT for the Detection of Distant Metastasis in Low-grade ER-positive Stage III Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 19 years or older
- Newly diagnosed with invasive breast cancer within 90 days prior to screening
- Histologically confirmed estrogen receptor-positive, histologic grade 1 or 2 primary breast cancer
- Clinical stage IIIA to IIIC disease according to AJCC TNM staging
- Completed or scheduled for chest CT, abdominal CT, and bone scintigraphy within 90 days prior to screening
- Eastern Cooperative Oncology Group performance status score of 2 or less
You will not qualify if you...
- Informed consent form not signed by the subject or legal representative
- Currently receiving systemic therapy for breast cancer (e.g., chemotherapy or hormonal therapy)
- History of another invasive cancer within the past 2 years, except non-melanoma skin cancer
- Diagnosed with distant metastases on recent imaging prior to 18F-FES PET/CT scan
- No biopsy or at least 6 months follow-up imaging performed for suspicious lesions
- Pregnant or breastfeeding women without confirmed effective contraception
- Serious, uncontrolled, or unstable medical conditions such as heart failure, severe lung disease, chronic kidney or liver disease
- Relatives or students of the investigator or those in a dependent relationship
- Unable to provide complete clinical trial data due to personal or other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 week
Participants undergo 18F-fluoroestradiol PET/CT imaging to detect distant metastases and lymph node involvement prior to definitive treatment.
1 visit (in-person)
Duration - Up to 6 months
Participants are monitored through clinical and imaging follow-up for up to 6 months to confirm imaging findings and assess treatment decisions.
Follow-up visits as needed over 6 months
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
S
Sangwon Han
J
Jaeeun Kim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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