Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

NCT01825213 | Completed

• 1 other identifier: 2013P000042
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease; HepatoCellular Carcinoma; Liver Fibrosis

Keywords

Liver disease; Multi Spectral CT

Outcome Measures

Primary Outcomes (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.

Study Arms (1)

Multispectral CT of the liver

Images of lesions and liver will be compared to histology.

Device: Multispectral CT of the liver

Interventions

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.

Also known as: Discovery CT 750 HD, K120833

Multispectral CT of the liver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients \< 18 years old.
• History of allergy to intravenous contrast.
• Patients at risk for contrast-induced-nephropathy,
• Pregnant patients.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital,

Boston, Massachusetts, 02114, United States

Location

Related Publications (7)

• 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.

  PMID: 25893236 BACKGROUND

• 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.

  PMID: 26796948 BACKGROUND

• 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.

  PMID: 27604894 BACKGROUND

• 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.

  PMID: 26993967 BACKGROUND

• 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.

  PMID: 27399237 BACKGROUND

• 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.

  PMID: 26860661 BACKGROUND

• 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.

  PMID: 27824670 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis; Liver Diseases

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dushyant V Sahani, MD

  Director of CT, Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of CT, Associate Professor of Radiology Harvard Medical School

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 5, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 17, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)