NCT07173868Recruiting
FDG PET-CT in Advanced Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 receiving first-line systemic therapy.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 20 Aug 2025
- Start date
- 25 Jul 2025
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Samsung Medical Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07173868
What you commit to
- Study type: Observational
- Planned participants: 100
- From 25 Jul 2025 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- a patient who has previously received systemic treatment for advanced breast cancer
Other illness
- 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)
- 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
Other
- Pregnancy or lactation
- If you are unable to follow a research procedure or follow-up
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.