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Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01825213
Enrollment
10
Registered
2013-04-05
Start date
2013-11-30
Completion date
2016-10-31
Last updated
2017-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Disease, HepatoCellular Carcinoma, Liver Fibrosis

Keywords

Liver disease, Multi Spectral CT

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.

Interventions

DEVICEMultispectral CT of the liver

Analysis of the background liver and liver lesions will be performed on Multi Spectral CT images and compared to histology.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Detection of hepatocellular carcinoma on Multi Spectral CTconfirmation with focal biopsy and or/contrast-enhanced MRI of the liver acquired within 6 months prior to the multi spectral CT scan.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026