Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT01311934
Status:
UNKNOWN
Last Update Posted:
2011-05-26
First Post:
2011-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-24', 'studyFirstSubmitDate': '2011-03-07', 'studyFirstSubmitQcDate': '2011-03-08', 'lastUpdatePostDateStruct': {'date': '2011-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Visceral Stiffness', 'Liver Fibrosis']}, 'descriptionModule': {'briefSummary': 'The acoustic radiation force impulse (ARFI) technology provides real-time measurements of tissue stiffness.\n\nAim: Using the ARFI ultrasonography, the investigators aims are to complete the correlation and validity studies between visceral ARFI quantification and the referenced Metavir fibrosis scoring and to conduct subsequent innovative studies on liver diseases.', 'detailedDescription': 'Using ARFI technology, we are establishing a complete hepatic and visceral shear wave spectrum to correspond to the entire METAVIR fibrosis scoring and various functional stratifications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic liver diseases', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with chronic liver diseases who underwent liver biopsy\n* patients with pathologically or radiologically proven cirrhosis\n\nExclusion Criteria:\n\n* Post major abdominal surgery\n* After interferon or neucleos(t)ides treatment\n* PBC,PSC,WD,AIH,viral coinfections\n* Liver abscess\n* Exposure to hepatotoxic drugs or chemicals\n* Thrombosis of splenic vein, portal veins\n* After resection or embolism of the spleen\n* Acute or chronic pancreatitis\n* Biopsy contraindications (not exclusive)\n* ARFI measurements low quality\n* Fibrotest contraindications:\n\nAcute hepatitides, Extrahepatic cholestasis, e.g., pancreatic cancer, gallstones, CBD\\>0.7cm Severe hemolysis\n\n* Cardiac congestion\n* Liver cancer other than HCC\n* Treated HCC'}, 'identificationModule': {'nctId': 'NCT01311934', 'acronym': 'ARFI', 'briefTitle': 'Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Clinical Application of the Spectrum of Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse Technology', 'orgStudyIdInfo': {'id': 'DMR100-IRB-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HBV-infected'}, {'label': 'HCV-infected'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40447', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Sheng-Hung Chen, MD', 'role': 'CONTACT', 'email': 'shcvghtc@gmail.com', 'phone': '886422052121', 'phoneExt': '2264'}], 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Sheng-Hung Chen, MD', 'role': 'CONTACT', 'email': 'shcvghtc@gmail.com', 'phone': '886422052121', 'phoneExt': '2264'}], 'overallOfficials': [{'name': 'Sheng-Hung Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital'}, {'name': 'Cheng-Yuan Peng, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sheng-Hung Chen', 'oldOrganization': 'China Medical University Hospital'}}}}