Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

HepatoCellular Carcinoma Clinical Trial

Official title:

Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825213
• Other study ID #: 2013P000042
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: April 13, 2017
• Start date: November 2013
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Chronic Liver Disease
• HepatoCellular Carcinoma
• Liver Cirrhosis
• Liver Diseases
• Liver Fibrosis

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital,	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

Lestra T, Mulé 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.