Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01825213
Collaborator
(none)
10
1
35
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Multispectral CT of the liver

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 Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Multispectral CT of the liver

Images of lesions and liver will be compared to histology.

Device: Multispectral CT of the liver
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
  • Outcome Measures

    Primary Outcome Measures

    1. 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.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital, Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Dushyant V Sahani, MD, Director of CT, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dushyant V. Sahani, Director of CT, Associate Professor of Radiology Harvard Medical School, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT01825213
    Other Study ID Numbers:
    • 2013P000042
    First Posted:
    Apr 5, 2013
    Last Update Posted:
    Apr 17, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dushyant V. Sahani, Director of CT, Associate Professor of Radiology Harvard Medical School, Massachusetts General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 17, 2017