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.

Study Overview

• Status: Completed
• Conditions: Liver Fibrosis; Chronic Liver Disease; HepatoCellular Carcinoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients with newly stablished diagnosis of hepatocellular carcinoma complying with selection criteria for liver transplantation and/or biopsy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Wang G, Butler A, Yu H, Campbell M. Guest editorial. Special issue on spectral CT. IEEE Trans Med Imaging. 2015 Mar;34(3):693-6. doi: 10.1109/tmi.2015.2404591. No abstract available.
• Zhao W, Niu T, Xing L, Xie Y, Xiong G, Elmore K, Zhu J, Wang L, Min JK. Using edge-preserving algorithm with non-local mean for significantly improved image-domain material decomposition in dual-energy CT. Phys Med Biol. 2016 Feb 7;61(3):1332-51. doi: 10.1088/0031-9155/61/3/1332.
• Breguet R, Ronot M, Goossens N, Hansen C, Giostra E, Majno P, Becker CD, Spahr L, Terraz S. Liver volume is a prognostic indicator for clinical outcome of patients with alcoholic hepatitis. Abdom Radiol (NY). 2017 Feb;42(2):460-467. doi: 10.1007/s00261-016-0892-7.
• Lestra T, Mule S, Millet I, Carsin-Vu A, Taourel P, Hoeffel C. Applications of dual energy computed tomography in abdominal imaging. Diagn Interv Imaging. 2016 Jun;97(6):593-603. doi: 10.1016/j.diii.2015.11.018. Epub 2016 Mar 15.
• Patino M, Prochowski A, Agrawal MD, Simeone FJ, Gupta R, Hahn PF, Sahani DV. Material Separation Using Dual-Energy CT: Current and Emerging Applications. Radiographics. 2016 Jul-Aug;36(4):1087-105. doi: 10.1148/rg.2016150220.
• Daginawala N, Li B, Buch K, Yu H, Tischler B, Qureshi MM, Soto JA, Anderson S. Using texture analyses of contrast enhanced CT to assess hepatic fibrosis. Eur J Radiol. 2016 Mar;85(3):511-7. doi: 10.1016/j.ejrad.2015.12.009. Epub 2015 Dec 17.
• De Cecco CN, Boll DT, Bolus DN, Foley WD, Kaza RK, Morgan DE, Rofsky NM, Sahani DV, Schoepf UJ, Shuman WP, Siegel MJ, Vrtiska TJ, Yeh BM, Berland LL. White Paper of the Society of Computed Body Tomography and Magnetic Resonance on Dual-Energy CT, Part 4: Abdominal and Pelvic Applications. J Comput Assist Tomogr. 2017 Jan;41(1):8-14. doi: 10.1097/RCT.0000000000000546.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 2, 2013
• First Submitted That Met QC Criteria: April 2, 2013
• First Posted (Estimate): April 5, 2013

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Liver disease; Multi Spectral CT
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Liver Cirrhosis
• Other Study ID Numbers: 2013P000042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Peer reviewed article
   Information identifier: PMID: 25181365

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No