Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

Conditions
-----------------
Chronic Liver Disease, HepatoCellular Carcinoma, Liver Fibrosis

Intervention / Treatment
-----------------
* Device: Multispectral CT of the liver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Patients < 18 years old. History of allergy to intravenous contrast. Patients at risk for contrast-induced-nephropathy, Pregnant patients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multispectral CT of the liver<br>Images of lesions and liver will be compared to histology. | Device: Multispectral CT of the liver<br>* Analysis of the background liver and liver lesions will be performed on Multi Spectral CT images and compared to histology.<br>* Other names: Discovery CT 750 HD, K120833;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of hepatocellular carcinoma on Multi Spectral CT |  | confirmation with focal biopsy and or/contrast-enhanced MRI of the liver acquired within 6 months prior to the multi spectral CT scan. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver disease, Multi Spectral CT