NCT01926990已完成不适用
Developing Non-Invasive Early Therapeutic Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Characterization of the relationship between Change in blood flow measured through perfusion CT techniques and Change in tumor size measured through non-investigational CT
研究概览
简要总结
This pilot clinical trial studies perfusion computed tomography (CT) in predicting response to treatment in patients with advanced kidney cancer. Comparing results of diagnostic procedures done before, during, and after targeted therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or biopsy-proven renal cell carcinoma
- •Treatment planned with sunitinib, pazopanib, sorafenib, bevacizumab, axitinib, nivolumab alone or in combination with an investigational agent
- •Ability to understand and willingness to sign a written informed consent document
排除标准
- •Serum creatinine greater than or equal to 1.7 mg/dL
- •Severe allergy to contrast agent
- •Any contraindication for undergoing a CT scan
- •Pregnancy or unwillingness to use preventative measures if a woman of child-bearing potential
结局指标
主要结局
Characterization of the relationship between Change in blood flow measured through perfusion CT techniques and Change in tumor size measured through non-investigational CT
时间窗: 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication
次要结局
- Characterization of the relationship between change in perfusion CT measurements (eg. Mean transit time) and change in tumor size measured by non-investigational CT(12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication)
- Relationship between change in blood flow and tumor response measured on ordinal scale(12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication)
- Relationship between change in blood flow at Day 8 and change in tumor size measured on continuous scale at Week 12 and tumor response measured on ordinal scale at Week 12(12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication)
- Relationship between change in blood flow at Day 8 and at Week 12 and progression-free survival(12 weeks after start of standard systemic targeted therapy medication)
- Relationship between change in blood flow at Day 8 and at Week 12 and time to nadir of tumor size(12 weeks after start of standard systemic targeted therapy medication)
研究者
研究点 (1)
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