Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

Cirrhosis Clinical Trial

Official title:

Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03176797
• Other study ID #: LC2016PY034
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. The purpose of this pilot study is to evaluate non-invasive multiparametric magnetic resonance imaging (MRI) techniques in the detection and grading of liver fibrosis, so that patients can be treated in time. These techniques combined could reach high diagnostic performance for detection of liver fibrosis, and could decrease the number of liver biopsies.

Description:

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. While liver biopsy is still considered the gold standard for diagnosing and assessing the presence and degree of liver fibrosis and inflammation, it has disadvantages including the potential for sampling error and risk of complications. New imaging modalities such as diffusion weighted imaging (DWI), intravoxel incoherent motion (IVIM), diffusion kurtosis imaging (DKI), T1ρ relaxation time (T1ρ), T1 mapping of pre-contrast and hepatocyte phase using hepatocyte specific agent and susceptibility weighted imaging (SWI) allow non-invasive evaluation of liver parenchymal characteristics and may be able to detect and quantify parenchymal fibrosis alleviating the need for biopsy. Patients with chronic liver disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included. Referred patients undergo multiparametric MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI before surgery or biopsy. The pathologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis. To explore if combine these techniques could reach higher diagnostic performance for detection and grading of liver fibrosis. This project will provide a reliable and noninvasive method for the monitoring stage of liver fibrosis and therapeutic evaluation.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...)
• AND willingly able to complete all research procedures and follow the entire research process
• AND scheduled for liver resection or biopsy
• AND signed informed consent

Exclusion Criteria:

• Any contraindication for contrast-enhanced MRI
• Pregnant or nursing women
• Any organ transplant history, and existing functional grafts (except corneal or fur grafts)
• Recent right upper quadrant patients with traumatic healed
• A serious history of illness or other evidence of a serious illness or suffering from any other disease
• Patients who have been enrolled in other interventional clinical trials

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

Intervention

Diagnostic Test:
• Liver MRI
Liver MRI including DWI, IVIM, DKI, T1?, T1 mapping of pre-contrast and hepatocyte phase and SWI.

Locations

Country	Name	City	State
China	ZhuJiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Zhujiang Hospital	Nanfang Hospital, Southern Medical University, Shenzhen Hospital of Southern Medical University, The Third Affiliated Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (9)

Friedrich-Rust M, Rosenberg W, Parkes J, Herrmann E, Zeuzem S, Sarrazin C. Comparison of ELF, FibroTest and FibroScan for the non-invasive assessment of liver fibrosis. BMC Gastroenterol. 2010 Sep 9;10:103. doi: 10.1186/1471-230X-10-103. — View Citation

Girometti R, Furlan A, Esposito G, Bazzocchi M, Como G, Soldano F, Isola M, Toniutto P, Zuiani C. Relevance of b-values in evaluating liver fibrosis: a study in healthy and cirrhotic subjects using two single-shot spin-echo echo-planar diffusion-weighted — View Citation

Hu G, Chan Q, Quan X, Zhang X, Li Y, Zhong X, Lin X. Intravoxel incoherent motion MRI evaluation for the staging of liver fibrosis in a rat model. J Magn Reson Imaging. 2015 Aug;42(2):331-9. doi: 10.1002/jmri.24796. Epub 2014 Nov 11. — View Citation

Hu G, Zhang X, Liang W, Zhong X, Chan Q, Lin X, Lin T, Li Y, Quan X. Assessment of liver fibrosis in rats by MRI with apparent diffusion coefficient and T1 relaxation time in the rotating frame. J Magn Reson Imaging. 2016 May;43(5):1082-9. doi: 10.1002/jm — View Citation

Kobayashi K, Nakao H, Nishiyama T, Lin Y, Kikuchi S, Kobayashi Y, Yamamoto T, Ishii N, Ohashi T, Satoh K, Nakade Y, Ito K, Yoneda M. Diagnostic accuracy of real-time tissue elastography for the staging of liver fibrosis: a meta-analysis. Eur Radiol. 2015 — View Citation

Petitclerc L, Sebastiani G, Gilbert G, Cloutier G, Tang A. Liver fibrosis: Review of current imaging and MRI quantification techniques. J Magn Reson Imaging. 2017 May;45(5):1276-1295. doi: 10.1002/jmri.25550. Epub 2016 Dec 16. — View Citation

Shiha G, Ibrahim A, Helmy A, Sarin SK, Omata M, Kumar A, Bernstien D, Maruyama H, Saraswat V, Chawla Y, Hamid S, Abbas Z, Bedossa P, Sakhuja P, Elmahatab M, Lim SG, Lesmana L, Sollano J, Jia JD, Abbas B, Omar A, Sharma B, Payawal D, Abdallah A, Serwah A, — View Citation

Wang YX, Yuan J, Chu ES, Go MY, Huang H, Ahuja AT, Sung JJ, Yu J. T1rho MR imaging is sensitive to evaluate liver fibrosis: an experimental study in a rat biliary duct ligation model. Radiology. 2011 Jun;259(3):712-9. doi: 10.1148/radiol.11101638. Epub 20 — View Citation

Zhao F, Wang YX, Yuan J, Deng M, Wong HL, Chu ES, Go MY, Teng GJ, Ahuja AT, Yu J. MR T1rho as an imaging biomarker for monitoring liver injury progression and regression: an experimental study in rats with carbon tetrachloride intoxication. Eur Radiol. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI T1? T1mapping SWI and DWI	Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with histology	MRI within 3 months of liver biopsy or surgery
Secondary	MRI T1? T1mapping SWI and DWI	Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with serological markers.	Blood Test taken on same day as MRI