Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

Completed

• Conditions: Chronic Liver Disease; Liver Fibrosis; HepatoCellular Carcinoma
• Interventions: Device: Multispectral CT of the liver

• Registration Number: NCT01825213
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-02
• Study First Posted: 2013-04-05
• Study Start: 2013-11
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multispectral CT of the liver	Multispectral CT of the liver	Images of lesions and liver will be compared to histology.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Massachusetts General Hospital,; 🇺🇸 Boston, Massachusetts, United States