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Completed

NCT Number: NCT01825213

Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multispectral CT of the liver

Device

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

Other names: Discovery CT 750 HD, K120833

Primary outcomes

  1. Detection of hepatocellular carcinoma on Multi Spectral CT

    Time frame: confirmation with focal biopsy and or/contrast-enhanced MRI of the liver acquired within 6 months prior to the multi spectral CT scan.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2013
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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