A Pilot Study to Assess the Feasibility of Cone Beam CT to Localize Liver Metastases Immediately Prior to Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants Eligible for Cone Beam Tumor Localization"
研究概览
简要总结
The purpose of this study is to test a new and possibly more accurate method of positioning patients with liver tumors in preparation for radiation treatment.
The positioning of patients with liver cancer is important because the tumor moves a bit when you breathe and makes it hard to determine the right position of the tumor at the time of treatment. Also, depending upon what is in your stomach at the time of treatment, it may change the shape of the liver and make it difficult to plan the radiation treatment. As part of this study, we will take a new type of image of your liver in addition to the standard portal images. This new type of image is called a cone-beam image. It shows a much more detailed picture of the liver tumors than the standard portal images. Normally, marker seeds need to be placed near the liver metastasis for radiation treatment. If the results of this study show that the tumor can be positioned as accurately with the new images as with the old images, then future patients with liver tumors would not have to have marker seeds placed into their liver. The use of cone beam imaging for the setup of patients with liver tumors is new.
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 95 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > than or equal to 18 years
- •KPS > than or equal to 80
- •Able to tolerate immobilization cradle positioning
- •Able to give informed consent
- •Histologically confirmed diagnosis of solid tumor malignancy
- •Liver metastases visualized on CT imaging
排除标准
- •Lymphoid primary histology (lymphoma/leukemia)
- •Allergic reaction to intravenous CT contrast
- •Liver function tests (AST, ALT, Bilirubin) > 2.0 x normal
- •Abnormal kidney function (serum creatinine > 1.5)
- •INR > 2.0, Platelet count <70.
- •Marker seed placement not possible
- •> 5mm excursion after abdominal compression
结局指标
主要结局
Number of Participants Eligible for Cone Beam Tumor Localization"
时间窗: Up to 2 hours
Assess the feasibility of using a new imaging technique called "cone beam imaging" to localize a liver tumor immediately prior to external beam radiotherapy.
次要结局
未报告次要终点
