NCT01105364Unknown不适用
Early Assessment of Anti-Angiogenic Treatment Efficacy in Advanced Renal Cancer by Using Contrast-Enhanced Sonography
National Cancer Institute, France2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Lesion size (main diameter)
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as contrast-enhanced ultrasound, may help measure a patient's response to treatment with drugs such as sunitinib malate, sorafenib tosylate, or bevacizumab, and allow doctors to plan better treatment.
PURPOSE: This clinical trial is studying ultrasonography in assessing antiangiogenic treatment in patients with advanced kidney cancer.
详细描述
OBJECTIVES:
Primary
- To determine if contrast-enhanced ultrasonography (CEUS) study of target metastasis from renal cancer leads to early assessment of pharmacodynamic effects of antiangiogenic treatment in patients with advanced renal cancer.
Secondary
- To determine the association between functional changes of microvascularization and the target lesion by CEUS and the early objective response for this lesion indicated by the time to progression.
- To determine the association between functional changes of microvascularization and the target lesion by CEUS and the early objective response for this lesion indicated by the global survey.
- To determine the tolerance to antiangiogenic treatments in these patients.
- To determine the relationship between functional changes of microvascularization and the target lesion and the objective response for the other lesions (RECIST criteria) in cases of other metastasis other than the target lesion.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of advanced renal cancer
- •Planning to receive antiangiogenic treatment
- •Detection of a target hepatic metastasis that is visible, located, and sized with conventional sonography and CT scan and/or MRI
- •PATIENT CHARACTERISTICS:
- •No active cardiac disease
- •No severe arterial hypertension
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Lesion size (main diameter)
Arrival time within lesion
Time-to-peak
β parameter from enhancement curve
Density of microvessels at peak enhancement
Enhancement ratio between the lesion and the surrounding parenchyma at peak value
Determination of necrotic and viable volume
Tumoral response determined by RECIST criteria
次要结局
- Time to progression
- Global survey
- Tolerance to antiangiogenic treatments
- Objective response for non-target lesions
研究者
研究点 (2)
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