Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Companion to Protocol 2010-0085
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Tumor Blood Flow (BF) Reduction
研究概览
简要总结
This is a companion protocol to MD Anderson Cancer Center study 2010-0085 (Sequential Therapy in Advanced Renal Cell Carcinoma Therapy: The "START" Trial).
The goal of this clinical research study is to learn if dynamic contrast enhanced computed tomography (DCE-CT) scans can help researchers learn if the study drug received as part of study 2010-0085 (either everolimus, bevacizumab, or pazopanib) is working.
详细描述
To perform a DCE-CT scan, a small amount of a special dye (called "CT contrast medium") is injected by vein into the body. Several CT images are then taken over a few minutes to learn how much dye spreads outside of the tumor. This can show how much blood flows to and from the tumor. By performing DCE-CT scans after several weeks on treatment, researchers may learn if changes in blood flow may be a sign that the treatment is working.
Study Procedures:
If you are found to be eligible to take part in this study, you will have a DCE-CT scan to check the status of the disease at the following times:
- Within about 4 weeks before you begin treatment on study 2010-0085.
- Eight (8) weeks after starting treatment on study 2010-0085.
Before each of the DCE-CT scans are performed, blood (about 1 tablespoon) will be drawn to check your kidney function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient must be enrolled or being considered for enrollment on protocol 2010-
- •Patients must have metastatic renal cell carcinoma (RCC).
- •Age >/= 18 years.
- •Subjects must have adequate renal function as defined by serum creatinine < 1.5x upper limit of normal.
排除标准
- •Radiotherapy: Subjects may not have received prior radiotherapy to the index lesion within 4 weeks
- •Female subjects who are pregnant or lactating.
- •Female subjects of childbearing potential (unless they have a negative serum or urine pregnancy test within 3 days prior to start of study treatment).
- •Allergy to CT contrast media requiring the administration of steroid prophylaxis.
研究组 & 干预措施
DCE-CT Scans
DCE-CT = Dynamic contrast enhanced CT - DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.
干预措施: Perfusion CT scan (Procedure)
结局指标
主要结局
Tumor Blood Flow (BF) Reduction
时间窗: From 4 weeks prior to first dose to 8 weeks post treatment
Changes in perfusion parameters assessed at first re-staging (approximately 8 weeks) and shortly after initiating therapy (2 - 7 days), for three different therapies using organ-directed DCE-CT tumor assessments. Tumor BF of index lesions computed using commercially available software (GE CT perfusion) using the same index lesion assessed on follow-up scans.
次要结局
- Progression Free Survival (PFS)(3 years)