Status:
RECRUITING
FDG PET-CT in Advanced Breast Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Histologically Confirmed Metastatic or Locally Advanced Breast Cancer With no Radical Topical Treatment Available
If There is Liver Metastasis, Which the Researcher Believes Will be Difficult to Evaluate the Response Accurately With Bone Metastasis or CT
Eligibility:
All Genders
19+ years
Brief Summary
This study is a prospective cohort study comparing metabolic response evaluation by F-18 FDG PET-CT versus conventional imaging for outcome stratification in patients with advanced breast cancer recei...
Detailed Description
PET-CT, CE-CT ± bone scan are performed before and during treatment (6, 12, 24, 48 weeks) of the first systemic treatment in a total of 100 patients with advanced breast cancer, and some patients anal...
Eligibility Criteria
Inclusion
- 19 years of age or older
- histologically confirmed metastatic or locally advanced breast cancer with no radical topical treatment available
- If there is liver metastasis, which the researcher believes will be difficult to evaluate the response accurately with bone metastasis or CT
- May or may not have measurable lesions in accordance with RECIST 1.1 criteria
- 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
- Patients scheduled to start primary systemic therapy for advanced breast cancer (endocrine therapy, targeted therapy, chemotherapy, immunotherapy or their combination therapy)
- 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
- ECOG Performance Status 0-2
Exclusion
- a patient who has previously received systemic treatment for advanced breast cancer
- 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)
- Pregnancy or lactation
- At the same time, other primary malignancies (except when treatment has been completed for radical purposes) are known
- Other medical conditions that, at the discretion of the researcher, may hinder participation in the study or affect the interpretation of the results
- If you are unable to follow a research procedure or follow-up
Key Trial Info
Start Date :
July 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07173868
Start Date
July 25 2025
End Date
December 31 2027
Last Update
September 15 2025
Active Locations (1)
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1
Samsung medical Center
Seoul, Gannam-gu, South Korea, 06351