NCT02257775终止不适用
Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer
Institute of Cancer Research, United Kingdom1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2015年5月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Progression rate of liver metastases
研究概览
简要总结
The objective of this study is to apply Whole-body DW imaging alongside the routine management of patients requiring systemic therapy for metastatic breast cancer to compare the time to progression of individual liver metastases within and between patients following stable disease or partial response to palliative systemic therapy for breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years.
- •First metastatic breast cancer relapse after treatment for early stage disease
- •A minimum of 10 evaluable lesions in the liver on routine x-ray CT imaging
- •Patient prescribed cytotoxic, endocrine or biological therapies
- •Patient physically and psychologically fit enough to consider sequential WB-- - DWI imaging alongside their standard disease monitoring
- •Written informed consent
排除标准
- •Diagnosis of other cancer within the last 5 years, other than resected non-melanoma skin cancer or cervical intraepithelial neoplasia
- •Diagnosis of brain metastases.
- •Contraindication to magnetic resonance MR imaging
结局指标
主要结局
Progression rate of liver metastases
时间窗: 3 months
Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy
次要结局
- Progression rate of skeletal metastases(3 months)
- Patient acceptability of WB-DWI assessed from questionnaires provided between WB-DWI scans and quantified using a 5-point Likert scale(3 months)
- Global and local lesion Apparent Diffusion Coefficient (ADC) distributions of WB-DWI scans within individual patient(3 months)
- Comparison of patient acceptability to whole-body CT(3 months)
研究者
研究点 (1)
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