PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained
研究概览
简要总结
Given the growing importance of anti-angiogenic therapies in the treatment of metastatic renal carcinoma, it is expected that this trial will establish the preliminary data needed to apply for funding of a larger clinical investigation of the potential role of PET perfusion imaging in management of renal carcinoma, and potentially other cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Ability to understand and willingness to sign a witnessed, informed consent and authorization for the release of health information.
- •Patients with a diagnosis of relapsed Stage IV renal cell cancer that are medically unresponsive to prior treatment or surgically unresectable and with metastases that fall within the PET/CT field-of-view that can include the heart.
- •Being considered for systemic therapy with Sunitinib
排除标准
- •Women who are pregnant, breast-feeding, or of childbearing potential and not using birth control
- •Having no telephone or a reliable way in which study personal can contact them
- •Subjects who are claustrophobic and cannot tolerate imaging procedures
- •Subjects who weigh > 350 lb. (upper weight limit of scanner beds)
研究组 & 干预措施
62Cu-ETS PET assessment
CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection
干预措施: 150-Water (Drug)
62Cu-ETS PET assessment
CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection
干预措施: 62Cu-ethylglyoxal bis (Drug)
62Cu-ETS PET assessment
CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection
干预措施: Positron Emission Tomography (Procedure)
62Cu-ETS PET assessment
CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection
干预措施: Sunitinib (Drug)
结局指标
主要结局
Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained
时间窗: Baseline
Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET
次要结局
- Maximum Standard Uptake Value (SUV) for Lesion Data(Baseline and 14-28 days after initiation of Sunitinib)
研究者
Theodore Logan
Associate Professor of Clinical Medicine
Indiana University