Medical and Economical Impact of Predicting the Response to Anti-angiogenic Treatment in Metastatic Renal Cell Carcinoma Using Functional CT and MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- RECIST criteria evolution
研究概览
简要总结
The goal is to study the impact of functional MRI and CT evaluation of changes in tumor vessels induced by anti-angiogenic treatment in patients with metastatic RCC.
The hypothesis is that good responders and poor responders will have different responses induced by anti-angiogenic treatment, and that the detection of theses changes by functional imaging can improve the therapeutic management.
Functional CT and MRI will be performed in 200 patients before the beginning of antiangiogenic treatment, 7 days after and every 6 week until tumor progression (as defined by the RECIST criteria). Perfusion and diffusion parameters will be measured using a dedicated software.
详细描述
The aim is to evaluate the capacity of functional CT and functional MRI to measure reliable biomarkers capable of evaluating the efficacy of anti-angiogenic treatment.
Patient and methods
- Patients 200 patients with metastatic RCC will be enrolled in the study. Patients will be recruited by an oncologist and the images will be acquired by a radiologist.
Patients will be followed until tumor progression (as defined by RECIST) or during 2 years following inclusion if there is no progression.
- Imaging data acquisition Morphological and functional imaging will be obtained before the beginning of the anti-angiogenic treatment, at 7±2 days and every 6 weeks until tumor progression.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with metastatic RCC
- •without previous recent antiangiogenic treatment
排除标准
- •severe renal insufficiency
- •allergy to contrast agents
- •pregnancy
结局指标
主要结局
RECIST criteria evolution
时间窗: at day 7 and after every 6 at 16 weeks during 2 years
time-to-progression with anti-angiogenic traitment evaluated by RECIST criteria
次要结局
- Validation of the technical and acquisition measurement models(at day 7 and after every 6 at 16 weeks during 2 years)
- Assessment of potential drug costs(at the end)