Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT06779058
Status:
RECRUITING
Last Update Posted:
2025-01-16
First Post:
2025-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005355', 'term': 'Fibrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-01-14', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the features of MRE for grading fibrosis in chronic hepatitis B.', 'timeFrame': '6 months', 'description': 'WIth liver biopsy as reference standand, the diagnostic perforemace (accuracy) for fibrosis of MRE was assessed.'}], 'secondaryOutcomes': [{'measure': 'The efficacy of grading liver fibrosis in CHB patients evaluated by MRE superior to TE and serological indicators (APRI, FIB-4).', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'The excellent ability of MRE as a non-invasive biomarker for longitudinal monitoring in CHB patients.', 'timeFrame': '12 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Magnetic resonance elastography', 'Liver stiffness', 'Antiviral therapy'], 'conditions': ['Chronic Hepatitis B', 'Liver Fibrosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMeanwhile, 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Confirmed CHB (laboratory, imaging and clinical tests)\n* MRE within 6 months before and after liver biopsy\n* Treatment-naïve\n* Child-Pugh Grade A (\\<7 points)\n* Written informed consent in prospective follow-up cohort\n\nExclusion Criteria:\n\n* Patients with liver malignant tumor\n* Chronic hepatitis due to other causes (such as alcoholic hepatitis)\n* CHB combined with hepatitis C, hepatitis D, or HIV\n* Patients with biliary tract diseases\n* Contraindications of MRE examination, MRE failure\n* Poor pathological effect'}, 'identificationModule': {'nctId': 'NCT06779058', 'briefTitle': 'MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'Retrospective and Prospective Multi-center Clinical Study of Magnetic Resonance Elastography in Evaluating Hepatic Fibrosis in Chronic Viral Hepatitis B', 'orgStudyIdInfo': {'id': 'ShengjingH CHB 2501'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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', 'interventionNames': ['Device: MRE', 'Device: Liver biopsy']}, {'label': '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', 'interventionNames': ['Device: MRE', 'Device: Liver biopsy']}], 'interventions': [{'name': 'MRE', 'type': 'DEVICE', 'description': 'All imaging studies were performed by using a 1.5T/3.0-T MRI system', 'armGroupLabels': ['Prospective follow-up cohort of patients confirmed diagnosed with chronic hepatitis B', 'Retrospective cohort of patients confirmed diagnosed with chronic hepatitis B']}, {'name': 'Liver biopsy', 'type': 'DEVICE', 'description': 'Liver biopsy are performed by well-trained pathologists in accordance with standard operating procedures.', 'armGroupLabels': ['Prospective follow-up cohort of patients confirmed diagnosed with chronic hepatitis B', 'Retrospective cohort of patients confirmed diagnosed with chronic hepatitis B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yiyang Wang', 'role': 'CONTACT', 'email': '15291014907@163.com', 'phone': '+86 15291014907'}, {'name': 'Yu Shi', 'role': 'CONTACT', 'email': '18940259980@163.com', 'phone': '+86 18940259980'}], 'facility': 'Shengjing Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Yiyang Wang', 'role': 'CONTACT', 'email': '15291014907@163.com', 'phone': '+86 15291014907'}, {'name': 'Yu Shi', 'role': 'CONTACT', 'email': '18940259980@163.com', 'phone': '+86 189 4025 9980'}], 'overallOfficials': [{'name': 'Yu Shi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shengjing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shengjing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy director of department of radology', 'investigatorFullName': 'Yu Shi', 'investigatorAffiliation': 'Shengjing Hospital'}}}}