FDG PET-CT to track treatment response in advanced breast cancer
Official title: 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 Receiving First-line Systemic Therapy
Run by Samsung Medical Center · NCT07173868 · Data updated 2026-11-12
This study will test whether FDG PET-CT scans better track treatment response than standard CT (± bone scan) in people starting first-line therapy for advanced breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Seoul, Gannam-gu) |
| Status | Recruiting |
| Started | July 25, 2025 |
| Main results expected | December 30, 2025 |
| Study ends | December 31, 2027 |
| Registry record updated | September 15, 2025 |
| Trial ID | NCT07173868 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (19+) with histologically confirmed metastatic or locally advanced breast cancer who are about to start primary systemic therapy and who meet national coverage criteria for FDG PET-CT for response evaluation are eligible.
✕Probably not a fit
Patients with early-stage disease, those not starting first-line systemic therapy, or whose tumors are poorly FDG-avid (for example some lobular cancers) may not benefit from PET-CT monitoring.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective cohort of 100 patients with metastatic or locally advanced breast cancer starting first-line systemic therapy. Participants receive F-18 FDG PET-CT and contrast-enhanced CT (with bone scan when needed) at baseline and at 6, 12, 24, and 48 weeks. In a subset, blood samples for ctDNA are collected at the same time points to explore minimal residual disease. The study compares metabolic response on PET-CT, conventional imaging findings, and ctDNA changes with progression-free survival to see which methods best predict outcomes.
Why it matters
Potential benefit: If successful, this approach could help doctors identify response or resistance earlier and guide better treatment decisions for people with advanced breast cancer.
How similar studies have gone: Previous studies have shown FDG PET-CT can often detect metabolic changes earlier than CT and predict outcomes in some breast cancer settings, but results have been variable and not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Samsung medical Center
Seoul, Gannam-gu, South Korea Recruiting
Study contacts
- Study coordinator: Yeon Hee Park, phD
- Email: yeonh.park@samsung.com
- Phone: +82-2-3410-1780
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.