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Diffusion-weighted Imaging Magnetic Resonance for Assessing Liver Fibrosis

Primary Purpose

Fibrosis, Liver

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Diffusion-weighted magnetic resonance imaging (DW-MRI)
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fibrosis, Liver focused on measuring Hepatitis B, Hepatitis C, Fibrosis, Liver, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All naive patients with chronic hepatitis B or C infection who undergo liver biopsy examination for evaluating candidates for antiviral therapy will be invited to participate into this study

Exclusion Criteria:

  • Other cause of chronic liver disease
  • Contraindication for liver biopsy
  • Contraindication for magnetic resonance imaging

Sites / Locations

  • Faculty of Medicine Siriraj Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Diffusion-weighted imaging

Arm Description

Magnetic resonance (MR) imaging examination of liver will be performed on a 3.0T Achieva MR scanner (Philips Medical Systems, The Netherlands). Diffusion-weighted imaging (DWI) will be performed using a single-shot echo-planar imaging during a single end expiratory breath-hold. A single observer placed circular regions of interest around 2.30 cm2 to measure mean signal intensity (SI) in the right hepatic lobe and the spleen for each b value, avoiding areas of artifact, vessels, and focal lesions. A monoexponential fit will be performed to calculate liver and spleen apparent diffusion coefficient (ADC) on the basis of ln(SI) as a function of b value, using all b values. Normalized liver ADC will be calculated as the ratio of liver ADC to spleen ADC.

Outcomes

Primary Outcome Measures

The correlation coefficient of the stage of hepatic fibrosis and liver apparent diffusion coefficient as assessed by DW-MRI
The primary aim of this study is to evaluate correlation between stage of hepatic fibrosis and liver apparent diffusion coefficient (ADC) and normalized liver ADC with spleen assessed by DW-MRI in patients with chronic viral hepatitis B or C.

Secondary Outcome Measures

The optimal cutoff values of DW-MRI for determining the stage of liver fibrosis
The aim of this study is to estimate the optimal cutoff values of DW-MRI for determining significant liver fibrosis (fibrosis stage ≥2) and advanced fibrosis (fibrosis stage ≥3).
The effects of hepatic steatosis, necroinflammation and hepatic iron on ADC values for determining the stage of liver fibrosis
The aim of this study is to evaluate whether the degree of hepatic steatosis, necroinflammation, and hepatic iron affect the values of liver ADC and normalized liver ADC with spleen for determining the stage of liver fibrosis.

Full Information

First Posted
February 6, 2016
Last Updated
September 13, 2016
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02682108
Brief Title
Diffusion-weighted Imaging Magnetic Resonance for Assessing Liver Fibrosis
Official Title
Diffusion-weighted Imaging Magnetic Resonance for Assessing Liver Fibrosis in Patients With Chronic Viral Hepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Several noninvasive radiological techniques have been investigated for the diagnosis of liver fibrosis and cirrhosis among patients with chronic infection with hepatitis B virus or hepatitis C virus. Diffusion-weighted magnetic resonance imaging (DW-MRI) is a particularly appealing method for the diagnosis of liver fibrosis. The aims of this study are to evaluate the accuracy of DW-MRI in patients with chronic viral hepatitis for determining the stage of liver fibrosis.
Detailed Description
Among patients with chronic infection with hepatitis B virus or hepatitis C virus, evaluation of the stage of liver fibrosis is of major importance for determining prognosis and therapeutic decisions. Liver biopsy is a costly and invasive technique with associated mortality and morbidity. A typical biopsy fragment represents only 1/50,000 of the organ. Several noninvasive radiological techniques have been investigated for the diagnosis of liver fibrosis and cirrhosis. Diffusion-weighted magnetic resonance imaging (DW-MRI) is a particularly appealing method for the diagnosis of liver fibrosis. Because it is easy to implement, non-operator dependent, and process without the need for contrast agents. However, preliminary studies on small numbers of patients in which various hardware and sequencing profiles were used have reported inconsistent results for staging liver fibrosis with DW-MRI. The aims of this study are to evaluate correlation between stage of hepatic fibrosis and liver apparent diffusion coefficient (ADC) and normalized liver ADC with spleen assessed by DW-MRI in patients with chronic viral hepatitis B or C. Also, this study aim to evaluate factors that influence liver ADC and normalized liver ADC with spleen value for predicting the stage of liver fibrosis as well as to estimate the optimal cutoff values of DW-MRI for determining significant liver fibrosis (fibrosis stage ≥2) and advanced fibrosis (fibrosis stage ≥3).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosis, Liver
Keywords
Hepatitis B, Hepatitis C, Fibrosis, Liver, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diffusion-weighted imaging
Arm Type
Other
Arm Description
Magnetic resonance (MR) imaging examination of liver will be performed on a 3.0T Achieva MR scanner (Philips Medical Systems, The Netherlands). Diffusion-weighted imaging (DWI) will be performed using a single-shot echo-planar imaging during a single end expiratory breath-hold. A single observer placed circular regions of interest around 2.30 cm2 to measure mean signal intensity (SI) in the right hepatic lobe and the spleen for each b value, avoiding areas of artifact, vessels, and focal lesions. A monoexponential fit will be performed to calculate liver and spleen apparent diffusion coefficient (ADC) on the basis of ln(SI) as a function of b value, using all b values. Normalized liver ADC will be calculated as the ratio of liver ADC to spleen ADC.
Intervention Type
Device
Intervention Name(s)
Diffusion-weighted magnetic resonance imaging (DW-MRI)
Intervention Description
Magnetic resonance (MR) imaging examination of liver will be performed on a 3.0T Achieva MR scanner (Philips Medical Systems, The Netherlands). Diffusion-weighted imaging (DWI) will be performed using a single-shot echo-planar imaging during a single end expiratory breath-hold. A single observer placed circular regions of interest around 2.30 cm2 to measure mean signal intensity (SI) in the right hepatic lobe and the spleen for each b value, avoiding areas of artifact, vessels, and focal lesions. A monoexponential fit will be performed to calculate liver and spleen apparent diffusion coefficient (ADC) on the basis of ln(SI) as a function of b value, using all b values. Normalized liver ADC will be calculated as the ratio of liver ADC to spleen ADC.
Primary Outcome Measure Information:
Title
The correlation coefficient of the stage of hepatic fibrosis and liver apparent diffusion coefficient as assessed by DW-MRI
Description
The primary aim of this study is to evaluate correlation between stage of hepatic fibrosis and liver apparent diffusion coefficient (ADC) and normalized liver ADC with spleen assessed by DW-MRI in patients with chronic viral hepatitis B or C.
Time Frame
At enrollment
Secondary Outcome Measure Information:
Title
The optimal cutoff values of DW-MRI for determining the stage of liver fibrosis
Description
The aim of this study is to estimate the optimal cutoff values of DW-MRI for determining significant liver fibrosis (fibrosis stage ≥2) and advanced fibrosis (fibrosis stage ≥3).
Time Frame
At enrollment
Title
The effects of hepatic steatosis, necroinflammation and hepatic iron on ADC values for determining the stage of liver fibrosis
Description
The aim of this study is to evaluate whether the degree of hepatic steatosis, necroinflammation, and hepatic iron affect the values of liver ADC and normalized liver ADC with spleen for determining the stage of liver fibrosis.
Time Frame
At enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All naive patients with chronic hepatitis B or C infection who undergo liver biopsy examination for evaluating candidates for antiviral therapy will be invited to participate into this study Exclusion Criteria: Other cause of chronic liver disease Contraindication for liver biopsy Contraindication for magnetic resonance imaging
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phunchai Charatcharoenwitthaya, MD
Organizational Affiliation
Faculty of Medicine Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no a plan to make individual participant data available.
Citations:
PubMed Identifier
17885048
Citation
Taouli B, Tolia AJ, Losada M, Babb JS, Chan ES, Bannan MA, Tobias H. Diffusion-weighted MRI for quantification of liver fibrosis: preliminary experience. AJR Am J Roentgenol. 2007 Oct;189(4):799-806. doi: 10.2214/AJR.07.2086.
Results Reference
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PubMed Identifier
26201529
Citation
Liaw YF, Kao JH, Piratvisuth T, Chan HL, Chien RN, Liu CJ, Gane E, Locarnini S, Lim SG, Han KH, Amarapurkar D, Cooksley G, Jafri W, Mohamed R, Hou JL, Chuang WL, Lesmana LA, Sollano JD, Suh DJ, Omata M. Erratum to: Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2012 update. Hepatol Int. 2012 Oct;6(4):809-10. doi: 10.1007/s12072-012-9386-z. No abstract available.
Results Reference
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PubMed Identifier
20658448
Citation
Soylu A, Kilickesmez O, Poturoglu S, Dolapcioglu C, Serez K, Sevindir I, Yasar N, Akyildiz M, Kumbasar B. Utility of diffusion-weighted MRI for assessing liver fibrosis in patients with chronic active hepatitis. Diagn Interv Radiol. 2010 Sep;16(3):204-8. doi: 10.4261/1305-3825.DIR.2810-09.1. Epub 2010 Jul 25.
Results Reference
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PubMed Identifier
23326162
Citation
Ferraioli G, Tinelli C, Dal Bello B, Zicchetti M, Lissandrin R, Filice G, Filice C, Above E, Barbarini G, Brunetti E, Calderon W, Di Gregorio M, Gulminetti R, Lanzarini P, Ludovisi S, Maiocchi L, Malfitano A, Michelone G, Minoli L, Mondelli M, Novati S, Patruno SF, Perretti A, Poma G, Sacchi P, Zanaboni D, Zaramella M. Performance of liver stiffness measurements by transient elastography in chronic hepatitis. World J Gastroenterol. 2013 Jan 7;19(1):49-56. doi: 10.3748/wjg.v19.i1.49.
Results Reference
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PubMed Identifier
17916549
Citation
Talwalkar JA, Kurtz DM, Schoenleber SJ, West CP, Montori VM. Ultrasound-based transient elastography for the detection of hepatic fibrosis: systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2007 Oct;5(10):1214-20. doi: 10.1016/j.cgh.2007.07.020.
Results Reference
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PubMed Identifier
21343496
Citation
Wang Y, Ganger DR, Levitsky J, Sternick LA, McCarthy RJ, Chen ZE, Fasanati CW, Bolster B, Shah S, Zuehlsdorff S, Omary RA, Ehman RL, Miller FH. Assessment of chronic hepatitis and fibrosis: comparison of MR elastography and diffusion-weighted imaging. AJR Am J Roentgenol. 2011 Mar;196(3):553-61. doi: 10.2214/AJR.10.4580.
Results Reference
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PubMed Identifier
21716125
Citation
Bonekamp S, Torbenson MS, Kamel IR. Diffusion-weighted magnetic resonance imaging for the staging of liver fibrosis. J Clin Gastroenterol. 2011 Nov-Dec;45(10):885-92. doi: 10.1097/MCG.0b013e318223bd2c.
Results Reference
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PubMed Identifier
23122674
Citation
Tosun M, Inan N, Sarisoy HT, Akansel G, Gumustas S, Gurbuz Y, Demirci A. Diagnostic performance of conventional diffusion weighted imaging and diffusion tensor imaging for the liver fibrosis and inflammation. Eur J Radiol. 2013 Feb;82(2):203-7. doi: 10.1016/j.ejrad.2012.09.009. Epub 2012 Nov 2.
Results Reference
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PubMed Identifier
23666523
Citation
Onur MR, Poyraz AK, Bozdag PG, Onder S, Aygun C. Diffusion weighted MRI in chronic viral hepatitis: correlation between ADC values and histopathological scores. Insights Imaging. 2013 Jun;4(3):339-45. doi: 10.1007/s13244-013-0252-x. Epub 2013 May 11.
Results Reference
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Diffusion-weighted Imaging Magnetic Resonance for Assessing Liver Fibrosis

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