Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

March 13, 2024 updated by: Quan Xianyue, Zhujiang Hospital
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Zhujiang Hospital of Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liver MRI
Liver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.
Diagnostic test: Liver MRI
Liver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI T1ρ T1mapping SWI and DWI
Time Frame: MRI within 3 months of liver biopsy or surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI T1ρ T1mapping SWI and DWI
Time Frame: Blood Test taken on same day as MRI
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Collaborators

The Third Affiliated Hospital of Southern Medical University
Shenzhen Hospital of Southern Medical University
Nanfang Hospital, Southern Medical University

Investigators

  • Principal Investigator: Xianyue Quan, MD, Southern Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2017

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 1, 2017

First Submitted That Met QC Criteria

June 1, 2017

First Posted (Actual)

June 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC2016PY034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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