Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Detection of hepatocellular carcinoma on Multi Spectral CT
研究概览
简要总结
The purpose of this study is to evaluate the feasibility to stratify liver fibrosis in patients with chronic liver disease through non-invasive, spectral CT.
详细描述
This is a retrospective study, in which a FDA approved imaging device (spectral CT scanner) currently used for several clinical applications will be evaluated for feasibility of studying chronic liver disease (this application has not yet been validated).
Tomographic imaging has assumed a fundamental role in patients with Chronic Liver Disease (CLD) to screen patients for hepatocellular carcinoma (HCC), and, is increasingly being explored as a noninvasive alternative for characterizing liver fibrosis. The overarching goal of this study is to improve noninvasive characterization of liver fibrosis through spectral CT.
Hypothesis
concentration of iodine-based contrast agent in the liver parenchyma during the delayed phase, as measured with spectral CT imaging, increases monotonically with Ishak fibrosis score obtained from liver biopsy. This hypothesis is supported by the literature and our preliminary data, described in the references section (Lamb et al. 2015).
We will evaluate multiphase spectral CT images consisting of the arterial phase, 2-minute delayed phase, and 5-minute delayed phase. Fibrosis will be assessed on both delayed phase images, where it is assumed that any remaining contrast agent, in the liver, is due to the presence of fibrosis. This type of multiphase protocol can still be used to image CLD patients with spectral CT for HCC detection and, thus, will not interfere with liver lesion workup and evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patient with chronic liver disease undergoing CT scan for/suspicion of hepatocellular carcinoma.
- •Patients should be scheduled for/or should have obtained a multiphasic MRI of the liver.
排除标准
- •Patients < 18 years old.
- •History of allergy to intravenous contrast.
- •Patients at risk for contrast-induced-nephropathy,
- •Pregnant patients.
结局指标
主要结局
Detection of hepatocellular carcinoma on Multi Spectral CT
时间窗: confirmation with focal biopsy and or/contrast-enhanced MRI of the liver acquired within 6 months prior to the multi spectral CT scan.
次要结局
未报告次要终点
研究者
Dushyant V. Sahani
Director of CT, Associate Professor of Radiology Harvard Medical School
Massachusetts General Hospital