Using MR elastography to assess liver fibrosis in chronic hepatitis B patients
Retrospective and Prospective Multi-center Clinical Study of Magnetic Resonance Elastography in Evaluating Hepatic Fibrosis in Chronic Viral Hepatitis B
This study is testing if a new imaging technique called MR elastography can help doctors better understand liver damage in adults with chronic hepatitis B without needing a liver biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shengjing Hospital Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06779058 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of magnetic resonance elastography (MRE) as a non-invasive method for grading liver fibrosis in patients with chronic hepatitis B (CHB). The study will involve patients aged 18 and older who have confirmed CHB and will compare MRE results with liver biopsy findings. By providing a more accurate and timely assessment of liver fibrosis, the study seeks to improve clinical management and treatment decisions for CHB patients. The research will also monitor disease progression over time to enhance patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed chronic hepatitis B who have not yet received antiviral treatment.
Not a fit: Patients with liver malignancies or chronic hepatitis due to other causes, as well as those with contraindications for MRE, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved non-invasive methods for assessing liver fibrosis, allowing for better management of chronic hepatitis B.
How similar studies have performed: Other studies have shown promising results using similar non-invasive imaging techniques for liver fibrosis assessment, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shenyang, Liaoning
- Shengjing Hospital — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Principal investigator: Yu Shi — Shengjing Hospital
- Study coordinator: Yiyang Wang
- Email: 15291014907@163.com
- Phone: +86 15291014907
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.