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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Follow up the response for 48 weeks after the start of the first systemic treatment
研究概览
简要总结
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.
详细描述
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 analyze ctDNA-based MRD by collecting blood at the same time point. We analyze the relationship between patient-specific responses and PFS, and compare the predictive performance of imaging and molecular indicators.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Follow up the response for 48 weeks after the start of the first systemic treatment
时间窗: Within 4 weeks prior to the start of primary systemic treatment
次要结局
未报告次要终点
研究者
Yeon Hee Park
Clinical Professor
Samsung Medical Center