Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-01-02 @ 5:11 AM
Study NCT ID:
NCT03487159
Status:
UNKNOWN
Last Update Posted:
2018-04-03
First Post:
2018-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054459', 'term': 'Elasticity Imaging Techniques'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The study model includes 2 study arms:\n\n1. Patients with chronic liver diseases who will undergo a routine liver biopsy, Shear Wave elastography and the MRE in order to evaluate the liver fibrosis stage.\n2. Patients with chronic liver diseases who will undergo a routine Shear Wave elastography and the MRE in order to evaluate the liver fibrosis stage.\n\nDemographic and clinical information will be collected from the patient's medical files."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-02', 'studyFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2018-04-02', 'lastUpdatePostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver Biopsy Result for liver fibrosis grade', 'timeFrame': 'Patient will undergo Liver biopsy once during 1 year of the study.', 'description': 'Liver Fibrosis score measured by Metavir scale .The Metavir score grades the degree of fibrosis on a 5-point scale from 0 to 4. The activity, which is the amount of inflammation (specifically, the intensity of necro-inflammatory lesions), is graded on a 4-point scale from A0 to A3.\n\nFibrosis score:\n\nF0 = no fibrosis F1 = portal fibrosis without septa F2 = portal fibrosis with few septa F3 = numerous septa without cirrhosis F4 = cirrhosis\n\nActivity score:\n\nA0 = no activity A1 = mild activity A2 = moderate activity A3 = severe activity Liver biopsy will be perfomed only according to physician recommendation.'}, {'measure': 'Magnetic Resonance Elastography (MRE) Result for liver fibrosis grade', 'timeFrame': 'Patient will undergo Magnetic Resonance Elastography (MRE) once during 1 year of the study.', 'description': 'Liver Fibrosis score determined by liver stiffness in 4 fibrosis grades: \\>1=any fibrosis, \\>2=significant fibrosis, \\>3=advanced fibrosis, 4=cirrhosis'}, {'measure': 'Shear Wave Elastography Result for liver fibrosis grade', 'timeFrame': 'Patient will undergo Shear Wave Elastography once during 1 year of the study.', 'description': 'Liver Fibrosis score determined by liver stiffness in in 5 fibrosis grades: 0=no fibrosis, \\>1=any fibrosis, \\>2=significant fibrosis, \\>3=advanced fibrosis, 4=cirrhosis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'This study evaluates the ability of Magnetic Resonance Elastography non invasive technology to identify the liver fibrosis stage in patients with chronic liver diseases compared to Shear Wave Elastography and/or Liver Biopsy.', 'detailedDescription': 'Recent advances in magnetic resonance imaging (MRI) of the liver have led to improvements in diagnosis of chronic liver diseases. Detection and staging of liver fibrosis has become important; however, until about the last decade, it depended on an invasive liver biopsy. Liver biopsy is limited by high cost, low patient acceptance, interobserver variability during microscopic evaluation, sampling error, poor reproducibility, and, importantly, an invasive nature with a complication rate of 3% and a mortality rate of 0.03%. With the emergence of elastography techniques, the need for liver biopsy has rapidly diminished for diagnosis of clinically significant liver fibrosis. Magnetic Resonance Elastography has gained increasing popularity in recent years, in large part due to its higher technical success and ability to overcome some of the weaknesses of ultrasound-based methods for assessing liver fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with chronic liver diseases\n\nExclusion Criteria:\n\n* Patients who don't have chronic liver diseases"}, 'identificationModule': {'nctId': 'NCT03487159', 'briefTitle': 'Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage', 'orgStudyIdInfo': {'id': 'SHEBA-17-4749-ZBA-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Liver biopsy ,Elastography and MRE', 'description': 'Performance of routine Liver biopsy,Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage.', 'interventionNames': ['Device: MRE (Magnetic Resonance Elastography)']}, {'type': 'OTHER', 'label': 'Elastography and MRE', 'description': 'Performance of routine Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage.', 'interventionNames': ['Device: MRE (Magnetic Resonance Elastography)']}], 'interventions': [{'name': 'MRE (Magnetic Resonance Elastography)', 'type': 'DEVICE', 'description': 'The device is using to evaluate liver fibrosis stage', 'armGroupLabels': ['Elastography and MRE', 'Liver biopsy ,Elastography and MRE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5265601', 'city': 'Ramat Gan', 'country': 'Israel', 'contacts': [{'name': 'Ziv Ben-Ari, MD', 'role': 'CONTACT', 'phone': '972-3-5307180'}, {'name': 'Avishag Hassid', 'role': 'CONTACT', 'email': 'avishag.hassid@sheba.health.gov.il', 'phone': '972-3-5307176'}, {'name': 'Ziv Ben-Ari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Avishag Hassid', 'role': 'CONTACT', 'email': 'avishag.hassid@sheba.health.gov.il', 'phone': '+972-35307176'}], 'overallOfficials': [{'name': 'Ziv Ben-Ari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liver Diseases Center, Sheba M.C'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Ziv Ben-Ari MD', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Liver Diseases Center', 'investigatorFullName': 'Prof. Ziv Ben-Ari MD', 'investigatorAffiliation': 'Sheba Medical Center'}}}}