MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B

February 26, 2026 updated by: Yu Shi, Shengjing Hospital

Retrospective and Prospective Multi-center Clinical Study of Magnetic Resonance Elastography in Evaluating Hepatic Fibrosis in Chronic Viral Hepatitis B

How to construct a non-invasive, accurate, and convenient method to evaluate the severity of liver fibrosis (LF) is an important general problem in the management of patients with chronic hepatitis B (CHB). We plan to investigate the ability of magnetic resonance elastography (MRE) to grade fibrosis in chronic hepatitis B and apply to clinical longitudinal follow-up.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hepatitis B virus (HBV) infection is the most prevalent chronic viral infection worldwide, affecting 254 million people and resulting in 1.2 million new infections annually . Chronic hepatitis B (CHB) is strongly associated with liver fibrosis, cirrhosis, hepatocellular carcinoma, and death. Patients with chronic hepatitis C (CHC) can achieve an overall cure rate of more than 95% after 12 weeks of treatment with direct-acting antiviral agent (DAA). However, patients with chronic hepatitis B still need long-term management due to the complexity and persistence of their disease. Therefore, rapid, stable and accurate assessment of the disease status of hepatitis B patients and clear classification of liver fibrosis are of great significance for clinical management of chronic hepatitis B patients.

Meanwhile, Antiviral therapy can significantly slow liver disease progression and improve long-term survival in CHB patients. Treatment is only recommended for CHB adults when histological evidences ≥ F2; evidence of F4 based on clinical criteria; HBV DNA > 2000 IU/mL with ALT > ULN (Men: 30 U/L, Women: 19 U/L); or persistent ALT abnormality. For treated patients, imaging and clinical indicators are monitored every six months during the first year, then annually. For untreated patients, monitoring is conducted on an annual basis . However, these current tests often fail to reflect pathological changes in real-time, as they tend to lag behind actual disease progression. Therefore, finding an effective method for regular follow-up is also essential for both treated and untreated patients.

The current diagnostic gold standard, liver biopsy, has limitations due to its invasive nature, sampling error, complications, and high cost, making it impractical for evaluating liver fibrosis and longitudinal monitoring in CHB patients. There is an urgent need for noninvasive evaluation of liver fibrosis and antiviral treatment efficacy. Magnetic resonance elastography (MRE) has shown promise in assessing liver fibrosis and necroinflammation in CHB patients. At present, there are few studies on CHB, all of which are single-center studies. The reported cut-off point is not uniform, which is generally lower than the international standard, and whether 2D/3D MRE affects the threshold are inconsistent. Therefore, a multi-center clinical study on the evaluation of CHB fibrosis based on MRE and its application in clinical longitudinal follow-up need to be carried out.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 210000

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

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Organize paticipating units to collect standard-of-care data including radiological and clinical data. Patients diagnosed with CHB who received liver biopsy and MRE should be enrolled.

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Confirmed CHB (laboratory, imaging and clinical tests)
  • MRE within 6 months before and after liver biopsy
  • Treatment-naïve
  • Child-Pugh Grade A (<7 points)
  • Written informed consent in prospective follow-up cohort

Exclusion Criteria:

  • Patients with liver malignant tumor
  • Chronic hepatitis due to other causes (such as alcoholic hepatitis)
  • CHB combined with hepatitis C, hepatitis D, or HIV
  • Patients with biliary tract diseases
  • Contraindications of MRE examination, MRE failure
  • Poor pathological effect

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective cohort of patients confirmed diagnosed with chronic hepatitis B
Patients aged ≥ 18 who have been diagnosed with chronic hepatitis B from Jan 2010 to Oct 2024
Device: MRE
All imaging studies were performed by using a 1.5T/3.0-T MRI system
Device: Liver biopsy
Liver biopsy are performed by well-trained pathologists in accordance with standard operating procedures.
Prospective follow-up cohort of patients confirmed diagnosed with chronic hepatitis B
Patients aged ≥ 18 who have been diagnosed with chronic hepatitis B, both treated and untreated from Aug 2022
Device: MRE
All imaging studies were performed by using a 1.5T/3.0-T MRI system
Device: Liver biopsy
Liver biopsy are performed by well-trained pathologists in accordance with standard operating procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the features of MRE for grading fibrosis in chronic hepatitis B.
Time Frame: 6 months
WIth liver biopsy as reference standand, the diagnostic perforemace (accuracy) for fibrosis of MRE was assessed.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of grading liver fibrosis in CHB patients evaluated by MRE superior to TE and serological indicators (APRI, FIB-4).
Time Frame: 6 months
WIth liver biopsy as reference standand, the efficacy of MRE, TE and serological indicators (APRI, FIB-4) in evaluating the classification of liver fibrosis were compared.
6 months
The excellent ability of MRE as a non-invasive biomarker for longitudinal monitoring in CHB patients.
Time Frame: 12 months
WIth QIBA Profile: Magnetic Resonance Elastography of the Liver as reference standand, changes in MRE and liver histology or clinical indicators during follow-up were investigated.
12 months

Collaborators and Investigators

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

Sponsor

Shengjing Hospital

Investigators

  • Principal Investigator: Yu Shi, Shengjing Hospital

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)

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 16, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShengjingH CHB 2501

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

product manufactured in and exported from the U.S.

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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