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Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

Primary Purpose

Liver Fibrosis, Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Liver MRI
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Fibrosis focused on measuring Liver Fibrosis, multiparametric magnetic resonance imaging

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ZhuJiang Hospital of Southern Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liver MRI

Arm Description

Liver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.

Outcomes

Primary Outcome Measures

MRI T1ρ T1mapping SWI and DWI
Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with histology

Secondary Outcome Measures

MRI T1ρ T1mapping SWI and DWI
Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with serological markers.

Full Information

First Posted
June 1, 2017
Last Updated
June 1, 2017
Sponsor
Zhujiang Hospital
Collaborators
Nanfang Hospital, Southern Medical University, The Third Affiliated Hospital of Southern Medical University, Shenzhen Hospital of Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03176797
Brief Title
Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI
Official Title
Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhujiang Hospital
Collaborators
Nanfang Hospital, Southern Medical University, The Third Affiliated Hospital of Southern Medical University, Shenzhen Hospital of Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis, Cirrhosis
Keywords
Liver Fibrosis, multiparametric 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
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liver MRI
Arm Type
Experimental
Arm Description
Liver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.
Intervention Type
Diagnostic Test
Intervention Name(s)
Liver MRI
Intervention Description
Liver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.
Primary Outcome Measure Information:
Title
MRI T1ρ T1mapping SWI and DWI
Description
Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with histology
Time Frame
MRI within 3 months of liver biopsy or surgery
Secondary Outcome Measure Information:
Title
MRI T1ρ T1mapping SWI and DWI
Description
Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with serological markers.
Time Frame
Blood Test taken on same day as MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xianyue Quan, MD
Organizational Affiliation
Southern Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZhuJiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25149296
Citation
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Results Reference
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PubMed Identifier
20828377
Citation
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.
Results Reference
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PubMed Identifier
21436087
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 2011 Mar 24.
Results Reference
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PubMed Identifier
22752522
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. 2012 Aug;22(8):1709-16. doi: 10.1007/s00330-012-2419-0. Epub 2012 Mar 27.
Results Reference
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PubMed Identifier
18666139
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 sequences. J Magn Reson Imaging. 2008 Aug;28(2):411-9. doi: 10.1002/jmri.21461.
Results Reference
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PubMed Identifier
25384923
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.
Results Reference
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PubMed Identifier
27714681
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, Hamed A, Elsayed A, AbdelMaqsod A, Hassanein T, Ihab A, GHaziuan H, Zein N, Kumar M. Asian-Pacific Association for the Study of the Liver (APASL) consensus guidelines on invasive and non-invasive assessment of hepatic fibrosis: a 2016 update. Hepatol Int. 2017 Jan;11(1):1-30. doi: 10.1007/s12072-016-9760-3. Epub 2016 Oct 6.
Results Reference
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PubMed Identifier
27981751
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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

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