Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT07173868
Eligibility Criteria:
Inclusion Criteria:
1. 19 years of age or older
2. histologically confirmed metastatic or locally advanced breast cancer with no radical topical treatment available
3. If there is liver metastasis, which the researcher believes will be difficult to evaluate the response accurately with bone metastasis or CT
4. May or may not have measurable lesions in accordance with RECIST 1.1 criteria
5. Patients who meet the criteria for coverage of F-18 FDG PET-CT tests conducted for the purpose of evaluating treatment response according to the Health Insurance Review and Assessment Service's announcement
6. Patients scheduled to start primary systemic therapy for advanced breast cancer (endocrine therapy, targeted therapy, chemotherapy, immunotherapy or their combination therapy)
7. Patients willing to undergo continuous response assessments using F-18 FDG PET-CT and CE-CT (± bone scan if clinically necessary) at the time point specified in the study plan (before treatment, 6, 12, 24, 48 weeks after treatment) and willing to pay for the examination accordingly
8. ECOG Performance Status 0-2
Exclusion Criteria:
1. a patient who has previously received systemic treatment for advanced breast cancer
2. Taboos for F-18 FDG PET-CT (e.g., uncontrolled diabetes) or intravenous contrast agents for CE-CT (e.g., severe allergies, severe renal dysfunction)
3. Pregnancy or lactation
4. At the same time, other primary malignancies (except when treatment has been completed for radical purposes) are known
5. Other medical conditions that, at the discretion of the researcher, may hinder participation in the study or affect the interpretation of the results
6. If you are unable to follow a research procedure or follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT07173868
Study Brief:
Protocol Section:
NCT07173868