MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B

China Medical University

Status: Enrolling

Conditions: Chronic Hepatitis B; Liver Fibrosis

Treatments: Device: MRE; Device: Liver biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT06779058

ShengjingH CHB 2501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

Retrospective cohort of patients confirmed diagnosed with chronic hepatitis B

Description:

Patients aged ≥ 18 who have been diagnosed with chronic hepatitis B from Jan 2010 to Oct 2024

Treatment:

Device: Liver biopsy

Device: MRE

Prospective follow-up cohort of patients confirmed diagnosed with chronic hepatitis B

Description:

Patients aged ≥ 18 who have been diagnosed with chronic hepatitis B, both treated and untreated from Aug 2022

Treatment:

Device: Liver biopsy

Device: MRE