Diffusion-weighted Imaging Magnetic Resonance for Assessing Liver Fibrosis

NCT02682108 | Completed

• 1 other identifier: Si237/2014
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibrosis, Liver

Keywords

Hepatitis B; Hepatitis C; Fibrosis, Liver; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  At enrollment

Secondary Outcomes (2)

• The optimal cutoff values of DW-MRI for determining the stage of liver fibrosis

  At enrollment

• The effects of hepatic steatosis, necroinflammation and hepatic iron on ADC values for determining the stage of liver fibrosis

  At enrollment

Study Arms (1)

Diffusion-weighted imaging

OTHER

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.

Device: Diffusion-weighted magnetic resonance imaging (DW-MRI)

Interventions

Diffusion-weighted magnetic resonance imaging (DW-MRI) DEVICE

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.

Diffusion-weighted imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (9)

• 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.

  PMID: 17885048 BACKGROUND

• 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.

  PMID: 26201529 BACKGROUND

• 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.

  PMID: 20658448 BACKGROUND

• 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.

  PMID: 23326162 BACKGROUND

• 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.

  PMID: 17916549 BACKGROUND

• 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.

  PMID: 21343496 BACKGROUND

• 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.

  PMID: 21716125 BACKGROUND

• 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.

  PMID: 23122674 BACKGROUND

• 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.

  PMID: 23666523 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Hepatitis B; Hepatitis C

Interventions

Diffusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Flaviviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Phunchai Charatcharoenwitthaya, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 6, 2016
• First Posted: February 15, 2016
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)