Improving Breast Cancer Staging With 18F-FDG PET/CT Imaging (The IMBRECAS PET Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in staging and/or management due to added 18F-FDG PET/CT scan
研究概览
简要总结
Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment.
Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC.
Objectives
Primary:
To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment.
Secondary:
- Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT.
- Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome.
- Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome.
- Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome.
- Blood and tumor samples for molecular characterisation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with high risk primary or recurrent breast cancer
- •Non pregnant women > 18 years
- •Not receiving active treatment of other cancer types.
- •Eastern Cooperative Oncology Group (ECOG) status 0-2.
排除标准
- •Pregnant woman
- •Age under 18
- •Patients receiving active treatment for other cancers
- •Poor general conditipon (ECOG 3 or higher)
结局指标
主要结局
Change in staging and/or management due to added 18F-FDG PET/CT scan
时间窗: 5 years
Percentage of the patients with change in staging and/or management
次要结局
- Overall survival(5 years)
