MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B
NCT ID: NCT06779058
Last Updated: 2025-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2025-01-01
2026-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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
MRE
All imaging studies were performed by using a 1.5T/3.0-T MRI system
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
MRE
All imaging studies were performed by using a 1.5T/3.0-T MRI system
Liver biopsy
Liver biopsy are performed by well-trained pathologists in accordance with standard operating procedures.
Interventions
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MRE
All imaging studies were performed by using a 1.5T/3.0-T MRI system
Liver biopsy
Liver biopsy are performed by well-trained pathologists in accordance with standard operating procedures.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Shengjing Hospital
OTHER
Responsible Party
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Yu Shi
Deputy director of department of radology
Principal Investigators
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Yu Shi
Role: PRINCIPAL_INVESTIGATOR
Shengjing Hospital
Locations
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Shengjing Hospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ShengjingH CHB 2501
Identifier Type: -
Identifier Source: org_study_id
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