Prospective Comparison Between TE, SWE and MRE (FULLFIBRO01)

Liver Fibrosis Clinical Trial

— FULLFIBRO01  

Official title:

Prospective Comparison Between Transient Elastography (TE), Shear Wave Elastography (SWE) and Magnetic Resonance Elastography (MRE) for Non-invasive Assessment of Liver Fibrosis in Patients Affected by Chronic Viral Hepatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03293953
• Other study ID #: 41UCS2016
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2017
• Last updated: September 21, 2017
• Start date: May 1, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: September 2017
• Source: Ente Ospedaliero Ospedali Galliera
• Contact: Gian Andrea Rollandi, MD
• Phone: 0039010563
• Email: gianandrea.rollandi[@]galliera.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main purpose of the present study is to compare the diagnostic performance of three non-invasive stiffness imaging methods (TE, SWE and MRE) in a consecutive cohort of patients with chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV).

Description:

Primary Endpoint: Verify if Transient Elastography, Shear Wave Elastography, Magnetic Resonance Elastography (MRE) get comparable results in the measurement of liver fibrosis Secondary Endpoint: To evaluate if the level of liver iron overload and steatosis may act as a confounding factor in stiffness measurements by MRE.

Tertiary Endpoint: to provide information about the prevalence and grade of steatosis in a consecutive cohort of patients with chronic viral C hepatitis, and to verify if the presence and grade of parenchymal steatosis may affect the correlation between the different non-invasive stiffness imaging modalities.

Subject: consecutive 100 patients affected by chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• enrollment of a consecutive cohort of at least 100 patients affected by chronic C virus hepatitis (HCV) or co-infected by HCV+ Human Immunodeficiency Virus (HIV).

Exclusion Criteria:

• contraindications to undergo MRI examination. Impossibility to obtain a valid TE measurement (e.g. narrow intercostal spaces; obese patients)

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

Locations

Country	Name	City	State
Italy	SC Radiodiagnostica	Genova

Sponsors (2)

Lead Sponsor	Collaborator
Ente Ospedaliero Ospedali Galliera	General Electric

Country where clinical trial is conducted

Italy, 

References & Publications (20)

Angelucci E, Giovagnoni A, Valeri G, Paci E, Ripalti M, Muretto P, McLaren C, Brittenham GM, Lucarelli G. Limitations of magnetic resonance imaging in measurement of hepatic iron. Blood. 1997 Dec 15;90(12):4736-42. — View Citation

Baranova A, Lal P, Birerdinc A, Younossi ZM. Non-invasive markers for hepatic fibrosis. BMC Gastroenterol. 2011 Aug 17;11:91. doi: 10.1186/1471-230X-11-91. Review. — View Citation

Bohte AE, de Niet A, Jansen L, Bipat S, Nederveen AJ, Verheij J, Terpstra V, Sinkus R, van Nieuwkerk KM, de Knegt RJ, Baak BC, Jansen PL, Reesink HW, Stoker J. Non-invasive evaluation of liver fibrosis: a comparison of ultrasound-based transient elastography and MR elastography in patients with viral hepatitis B and C. Eur Radiol. 2014 Mar;24(3):638-48. doi: 10.1007/s00330-013-3046-0. Epub 2013 Oct 25. — View Citation

Bravo AA, Sheth SG, Chopra S. Liver biopsy. N Engl J Med. 2001 Feb 15;344(7):495-500. Review. — View Citation

Bydder M, Yokoo T, Hamilton G, Middleton MS, Chavez AD, Schwimmer JB, Lavine JE, Sirlin CB. Relaxation effects in the quantification of fat using gradient echo imaging. Magn Reson Imaging. 2008 Apr;26(3):347-59. Epub 2008 Feb 21. — View Citation

Castera L. Invasive and non-invasive methods for the assessment of fibrosis and disease progression in chronic liver disease. Best Pract Res Clin Gastroenterol. 2011 Apr;25(2):291-303. doi: 10.1016/j.bpg.2011.02.003. Review. — View Citation

European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2011 Aug;55(2):245-64. doi: 10.1016/j.jhep.2011.02.023. Epub 2011 Mar 1. — View Citation

Ferraioli G, Tinelli C, Lissandrin R, Zicchetti M, Dal Bello B, Filice G, Filice C. Point shear wave elastography method for assessing liver stiffness. World J Gastroenterol. 2014 Apr 28;20(16):4787-96. doi: 10.3748/wjg.v20.i16.4787. — View Citation

Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. doi: 10.1002/hep.22759. — View Citation

Manduca A, Oliphant TE, Dresner MA, Mahowald JL, Kruse SA, Amromin E, Felmlee JP, Greenleaf JF, Ehman RL. Magnetic resonance elastography: non-invasive mapping of tissue elasticity. Med Image Anal. 2001 Dec;5(4):237-54. — View Citation

Negro F. Mechanisms and significance of liver steatosis in hepatitis C virus infection. World J Gastroenterol. 2006 Nov 14;12(42):6756-65. Review. — View Citation

Paparo F, Cenderello G, Revelli M, Bacigalupo L, Rutigliani M, Zefiro D, Cevasco L, Amico M, Bandelloni R, Cassola G, Forni GL, Rollandi GA. Diagnostic value of MRI proton density fat fraction for assessing liver steatosis in chronic viral C hepatitis. Biomed Res Int. 2015;2015:758164. doi: 10.1155/2015/758164. Epub 2015 Mar 19. — View Citation

Paparo F, Cevasco L, Zefiro D, Biscaldi E, Bacigalupo L, Balocco M, Pongiglione M, Banderali S, Forni GL, Rollandi GA. Diagnostic value of real-time elastography in the assessment of hepatic fibrosis in patients with liver iron overload. Eur J Radiol. 2013 Dec;82(12):e755-61. doi: 10.1016/j.ejrad.2013.08.038. Epub 2013 Aug 30. — View Citation

Paparo F, Corradi F, Cevasco L, Revelli M, Marziano A, Molini L, Cenderello G, Cassola G, Rollandi GA. Real-time elastography in the assessment of liver fibrosis: a review of qualitative and semi-quantitative methods for elastogram analysis. Ultrasound Med Biol. 2014 Sep;40(9):1923-33. doi: 10.1016/j.ultrasmedbio.2014.03.021. Epub 2014 Jun 25. Review. — View Citation

Regev A, Berho M, Jeffers LJ, Milikowski C, Molina EG, Pyrsopoulos NT, Feng ZZ, Reddy KR, Schiff ER. Sampling error and intraobserver variation in liver biopsy in patients with chronic HCV infection. Am J Gastroenterol. 2002 Oct;97(10):2614-8. — View Citation

Sun HY, Lee JM, Han JK, Choi BI. Usefulness of MR elastography for predicting esophageal varices in cirrhotic patients. J Magn Reson Imaging. 2014 Mar;39(3):559-66. doi: 10.1002/jmri.24186. Epub 2013 Sep 23. — View Citation

Tang A, Cloutier G, Szeverenyi NM, Sirlin CB. Ultrasound Elastography and MR Elastography for Assessing Liver Fibrosis: Part 1, Principles and Techniques. AJR Am J Roentgenol. 2015 Jul;205(1):22-32. doi: 10.2214/AJR.15.14552. Epub 2015 Apr 23. Review. — View Citation

Tang A, Cloutier G, Szeverenyi NM, Sirlin CB. Ultrasound Elastography and MR Elastography for Assessing Liver Fibrosis: Part 2, Diagnostic Performance, Confounders, and Future Directions. AJR Am J Roentgenol. 2015 Jul;205(1):33-40. doi: 10.2214/AJR.15.14553. Epub 2015 Apr 23. — View Citation

Yoon JH, Lee JM, Joo I, Lee ES, Sohn JY, Jang SK, Lee KB, Han JK, Choi BI. Hepatic fibrosis: prospective comparison of MR elastography and US shear-wave elastography for evaluation. Radiology. 2014 Dec;273(3):772-82. doi: 10.1148/radiol.14132000. Epub 2014 Jul 7. — View Citation

Ziol M, Handra-Luca A, Kettaneh A, Christidis C, Mal F, Kazemi F, de Lédinghen V, Marcellin P, Dhumeaux D, Trinchet JC, Beaugrand M. Noninvasive assessment of liver fibrosis by measurement of stiffness in patients with chronic hepatitis C. Hepatology. 2005 Jan;41(1):48-54. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver stiffness	liver stiffness is indicated in kPa	18 months
Secondary	liver iron overload	liver iron concentration (LIC) is indicated in mg/g dw	18 months
Secondary	liver steatosis	liver steatosis	18 months