Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-27 @ 1:30 AM
Study NCT ID:
NCT05163132
Status:
UNKNOWN
Last Update Posted:
2022-01-06
First Post:
2021-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shear-wave Elastography Diffuse Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'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': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-17', 'studyFirstSubmitDate': '2021-12-06', 'studyFirstSubmitQcDate': '2021-12-06', 'lastUpdatePostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shearwave elastography (SWE) of the liver', 'timeFrame': '1 week', 'description': 'Analyze the correlation between SWE of liver and with computed tomography findings.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatic', 'Chronic Liver Disease and Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '19959510', 'type': 'RESULT', 'citation': 'Boll DT, Merkle EM. Diffuse liver disease: strategies for hepatic CT and MR imaging. Radiographics. 2009 Oct;29(6):1591-614. doi: 10.1148/rg.296095513.'}, {'pmid': '26600216', 'type': 'RESULT', 'citation': 'Lingala S, Ghany MG. Natural History of Hepatitis C. Gastroenterol Clin North Am. 2015 Dec;44(4):717-34. doi: 10.1016/j.gtc.2015.07.003. Epub 2015 Aug 25.'}, {'pmid': '26131943', 'type': 'RESULT', 'citation': 'Wilkins T, Akhtar M, Gititu E, Jalluri C, Ramirez J. Diagnosis and Management of Hepatitis C. Am Fam Physician. 2015 Jun 15;91(12):835-42.'}, {'pmid': '22767302', 'type': 'RESULT', 'citation': 'Ferraioli G, Tinelli C, Dal Bello B, Zicchetti M, Filice G, Filice C; Liver Fibrosis Study Group. Accuracy of real-time shear wave elastography for assessing liver fibrosis in chronic hepatitis C: a pilot study. Hepatology. 2012 Dec;56(6):2125-33. doi: 10.1002/hep.25936. Epub 2012 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to correlate between quantitative results of shear wave elastography and CT picture in diffuse liver disease, including liver cirrhosis.', 'detailedDescription': 'Many pathophysiological processes can lead to diffuse parenchymal liver diseases and the end-result of all chronic liver diseases is healing by fibrosis and regeneration. Liver fibrosis is a slowly progressing disease in which healthy liver tissue is replaced with scar tissue ended with liver cirrhosis, with a variety of causes, including viral, drug induced, autoimmune, cholestatic, and metabolic diseases.\n\nLiver biopsy is the gold standard but limited due to its invasiveness, sampling error, and intra- and interobserver variability. Non-invasive tests are preferred in the management of chronic liver diseases. Several serum tests for liver function and markers of liver fibrosis are available and have moderate sensitivity and specificity; however, they are confounded by a wide range of extra-hepatic diseases.\n\nCurrently, several methods are available for assessing hepatic fibrosis and progression of fibrogenesis including scintigraphy, magnetic resonance diffusion weighted imaging, and magnetic resonance spectroscopy could differentiate between cirrhosis or severe fibrosis and normal liver. However, an accurate staging of fibrosis or diagnosis of mild fibrosis was often not achievable. Shear-wave elastography (SWE) is a real-time freehand ultrasonography-based elastography method for liver stiffness measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who diagnosed to had chronic liver diseases with or without present hepatic focal lesions.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both sexes are included: patients who diagnosed to had chronic liver diseases with or without present hepatic focal lesions.\n\nExclusion Criteria:\n\n* Lactating and pregnant women\n* Patients known to had high serum creatinine'}, 'identificationModule': {'nctId': 'NCT05163132', 'briefTitle': 'Shear-wave Elastography Diffuse Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Correlation Between Shear-wave Elastography and CT in Diffuse Liver Disease', 'orgStudyIdInfo': {'id': 'Fibroscan'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Shearwave elastography', 'type': 'DEVICE', 'description': 'Shear wave elastography is an ultrasound applied technique used to measure tissue stiffness as a result of a disease. So, it can be used to evaluate liver stiffness as a result of liver cirrhosis'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Abdeltawab, MD', 'role': 'CONTACT', 'email': 'dr.m.tawab@gmail.com', 'phone': '+201009319309', 'phoneExt': '+20'}], 'overallOfficials': [{'name': 'Mohamed Abdeltawab, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut'}, {'name': 'Hayam M Abd El-hakeem', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}, {'name': 'Eman Abo El-hamd', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Abdel-Tawab Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}