Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

NCT ID: NCT01825213

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-10-31

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.

Conditions

Chronic Liver Disease; HepatoCellular Carcinoma; Liver Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Multispectral CT of the liver

Images of lesions and liver will be compared to histology.

Multispectral CT of the liver

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Discovery CT 750 HD, K120833

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dushyant V. Sahani

Director of CT, Associate Professor of Radiology Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dushyant V Sahani, MD

Role: PRINCIPAL_INVESTIGATOR

Director of CT, Massachusetts General Hospital

Locations

Massachusetts General Hospital,

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25893236 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26796948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27604894 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26993967 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27399237 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26860661 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27824670 (View on PubMed)

Study Documents

Document Type: Peer reviewed article

View Document

Other Identifiers

2013P000042

Identifier Type: -

Identifier Source: org_study_id