Machine Learning Approach to Sonographic Assessment of Tumor Volumes for Response Assessment in Patients With Pancreas or Gastrointestinal Adenocarcinoma: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- measurement differences between ultrasound tumor volumes
研究概览
简要总结
The purpose of this study is to see if ultrasound images that are analyzed by a special computer program can be used to measure the size of PDAC tumors in the liver as accurately as CT scans that involve contrast material (also called contrast-enhanced CT scans). All participants in this study will have pancreatic ductal adenocarcinoma (PDAC) that has spread (metastasized) to the liver, and all participants will be scheduled for a routine CT scan that will measure their cancer.
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
- •Male and female patients, 18 years of age or older
- •Confirmed diagnosis of PDAC or GI tract adenocarcinoma metastatic to liver
- •Scheduled for imaging with contrast enhanced CT
排除标准
- •Inability to tolerate intravenous contrast medium
- •All liver metastases ≤ 10 mm in maximal diameter on the contrast enhanced CT used for comparison to the planned research ultrasound
- •Multiple confluent liver metastases or tumor burden > 50% of the liver as estimated by a radiologist
结局指标
主要结局
measurement differences between ultrasound tumor volumes
时间窗: 1 year
Measure the range of volumetric changes of liver metastases observed between rUS1 and rUS2. We will correlate the rate (%) of tumor volumetric change between the rUS1 and rUS2 to the rate of change between the two CECT.
次要结局
未报告次要终点