Rapid Breath-hold Quantitative Macromolecular Proton Fraction Imaging for Liver Fibrosis

February 7, 2023 updated by: Chen Weitian, Chinese University of Hong Kong

Assessment of Fibrosis by Non-invasive Quantitative Imaging of Collagen in the Liver Using Breath-hold MRI With Comparison With MR Elastography and Liver Biopsy

Chronic liver disease is a major health problem worldwide. Liver fibrosis is a key feature in most chronic liver diseases. When identified early, liver fibrosis may be reversible. Currently, liver biopsy is the gold standard for the diagnosis of liver fibrosis. Liver biopsy; however, is invasive. Non-invasive diagnostic tools are increasingly used in clinical practice. However, the existing noninvasive methods still have significant limitations to detect early-stage liver fibrosis.

Liver fibrosis is characterized by excessive deposition of collagen-rich connective tissues in the liver. The macromolecular proton fraction (MPF) is an MRI parameter which characterizes the magnetization transfer (MT) effect in tissues. Quantitative MPF imaging is non-invasive and can be used to measure collagen deposition in the liver due to the strong MT effect of collagen. It has been reported MPF quantification can be used for diagnosis of early-stage liver fibrosis. However, the existing approaches require B1, B0, and T1 map in addition to the imaging data for MPF quantification, which makes it challenging to adopt them for routine clinical use.

The investigators propose a fast and robust MPF quantification approach. In contrast to the existing methods which rely on saturation radiofrequency pulses for MPF quantification, our approach is based on spin-lock radiofrequency pulses which have minimum Rabi oscillations. The whole imaging data can be acquired within a breath-hold less than 8 seconds. Our approach only needs a B1 map in addition to the imaging data for MPF quantification. The preliminary clinical studies on 3.0T MRI show the measurement using our approach is specific to collagen content and can be used to detect early-stage liver fibrosis. To further confirm the clinical value of the proposed approach, the investigators will investigate the relationship of the collagen content measured using the proposed non-invasive imaging approach and those measured based on morphometry analysis of histology, and determine the diagnostic value of the proposed method for detection of early stage liver fibrosis in a large cohort. The investigators will also perform comparative studies of the proposed method and the state-of-the-art quantitative MPF imaging technique.

This project will provide a diagnostic technology for early detection of liver fibrosis. The proposed MRI technology also has potential to be used for other clinical purposes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

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

  • Hong Kong
    • Shatin
      • Hong Kong, Shatin, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong, Prince of Wale Hospital

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients referred to hepatology center affiliated to The Chinese University of Hong Kong (CUHK) will be enrolled in this study. The research team led by one hepatologist as one of our collaborators will be responsible for patient recruitment.

Description

Inclusion Criteria:

  1. Patient group

    • patients with histology-proven liver fibrosis, including those with liver fibrosis stage F0, early-stage liver fibrosis (F1-2), and late stage.

    liver fibrosis(F3-4).

    • patient aged 18 years old and above.

  2. Healthy control group

    • controls aged 18 years old and above.

Exclusion Criteria:

  • Contraindications to MRI, such as cardiac pacemaker, claustrophobia, pregnancy, metallic implants not suitable for MRI scan.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
liver fibrosis stage F0
Diagnostic test: Magnetic Resonance Imaging
One novel MRI sequence, i.e. the quantitative imaging of macromolecular proton fraction (MPF), will be introduced into this study. MPF is defined as the relative amount of protons associated with macromolecules involved in magnetization exchange with free water protons. This parameter is independent of the pool model used for quantification and the pulse sequences used for data acquisition. Recent studies have found a strong association between MPF and collagen content in the fibrotic liver, indicating MPF is a potential biomarker of early-stage liver fibrosis.
early-stage liver fibrosis (F1-2)
Diagnostic test: Magnetic Resonance Imaging
One novel MRI sequence, i.e. the quantitative imaging of macromolecular proton fraction (MPF), will be introduced into this study. MPF is defined as the relative amount of protons associated with macromolecules involved in magnetization exchange with free water protons. This parameter is independent of the pool model used for quantification and the pulse sequences used for data acquisition. Recent studies have found a strong association between MPF and collagen content in the fibrotic liver, indicating MPF is a potential biomarker of early-stage liver fibrosis.
late-stage liver fibrosis (F3-4)
Diagnostic test: Magnetic Resonance Imaging
One novel MRI sequence, i.e. the quantitative imaging of macromolecular proton fraction (MPF), will be introduced into this study. MPF is defined as the relative amount of protons associated with macromolecules involved in magnetization exchange with free water protons. This parameter is independent of the pool model used for quantification and the pulse sequences used for data acquisition. Recent studies have found a strong association between MPF and collagen content in the fibrotic liver, indicating MPF is a potential biomarker of early-stage liver fibrosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic accuracy
Time Frame: 3 years
diagnostic accuracy of quantitative macromolecular proton fraction imaging based on spin-lock (MPF-SL) for detecting early-stage liver fibrosis.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation coefficient
Time Frame: 3 years
correlations between the MPF quantification and the morphometric scores
3 years

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

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)

March 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

June 30, 2024

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (ACTUAL)

June 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019.660

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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