Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-26 @ 11:14 AM
Study NCT ID:
NCT03375008
Status:
COMPLETED
Last Update Posted:
2019-05-16
First Post:
2017-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictable MR Index for Nonalcoholic Steatohepatitis (NASH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2017-11-22', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiologic Diagnosis & Criteria of nonalcoholic steatohepatitis(NASH)', 'timeFrame': 'up to 23 month', 'description': 'Development of non-invasive magnetic resonance imaging diagnostic model for NASH using linear regression analysis\n\n1. Linear regression analysis using three magnetic resonance(MR) parameters 1) Fat signal fraction measured on MR spectroscopy (unit: %) 2) Liver stiffness measured on MR elastography (unit: kPa) 3) T1 relaxation time measured on T1 mapping (unit: msec) → Development of linear equation for NAFLD activity score (NAS) and Steatosis, Activity, Fibrosis (SAF) score\n2. Fitting of observed values (NAS, SAF score) and predicted values (NAS, SAF score) → Obtaining R square (R2) (Unit: none)'}], 'secondaryOutcomes': [{'measure': 'Fat imaging : Fat signal fraction measured on magnetic resonance(MR) spectroscopy', 'timeFrame': 'During scanning, up to 15 seconds', 'description': '\\* Fat signal fraction measured on magnetic resonance(MR) spectroscopy\n\n1. high speed T2-corrected multi-echo (HISTO) MR spectroscopic technique\n\n * multiple short echo time : correction of T2 bias\n * long repetition time: correction of T1 bias\n2. 15 x 15 x 15-mm square-shaped region-of-interest(ROI) → Right hepatic lobe\n3. 3 times measurement → mean value was used as a representative value\n4. unit: percentage (%)\n5. Receiver operating characteristic (ROC) curve analysis for steatosis grade (0-3) → Obtaining cut-off values of each steatosis grade and area under the curve (AUC)'}, {'measure': 'Fibrosis imaging(1) : Liver stiffness measured on magnetic resonance elastography(MRE)', 'timeFrame': 'During scanning, up to 20 seconds', 'description': '\\* Magnetic resonance elastography(MRE)\n\n1. 60 Hz acoustic wave\n2. Four slices were obtained for each magnetic resonance elastography(MRE) examination\n3. Stiffness maps (elastograms) for each magnetic resonance elastography(MRE) slices were automatically generated\n4. free-hand region-of-interest (ROI) on the right hepatic lobe\n5. 5 times measurement → mean value was used as a representative value\n6. unit: kilopascal (kPa)\n7. Receiver operating characteristic (ROC) curve analysis for fibrosis grade (0-4) → Obtaining cut-off values of each fibrosis grade and area under the curve (AUC)'}, {'measure': 'Fibrosis imaging(2) : T1 relaxation time measured on T1 mapping', 'timeFrame': 'During scanning, up to 20 seconds', 'description': '\\* T1 mapping\n\n1. Shortened Modified Look Locker Inversion (shMOLLI) recovery sequence\n2. Four slices were obtained for each T1 map\n3. Oval-shaped region-of-interest (ROI) in the right hepatic lobe\n4. 5 times measurement → mean value was used as a representative value\n5. unit: millisecond (msec)\n6. Receiver operating characteristic (ROC) curve analysis for ballooning (0-2), lobular inflammation (0-3), fibrosis grade (0-4) → Obtaining cut-off values of each grade and area under the curve (AUC)'}, {'measure': 'Histologic interpretation(1) : Nonalcoholic fatty liver disease activity score (NAS)', 'timeFrame': 'Up to a week', 'description': '1. the sum of each histological component semiquantitatively evaluated as follows: steatosis (0-3), ballooning (0-2), and lobular inflammation (0-3)\n2. NAS 0-2: not considered steatohepatitis\n3. NAS 3-4: possible steatohepatitis 4/ NAS ≥5: definite steatohepatitis'}, {'measure': 'Histologic interpretation(1) : Steatosis, Activity, Fibrosis (SAF) score', 'timeFrame': 'Up to a week', 'description': '1. steatosis (0-3), ballooning degeneration (0-2), lobular inflammation (0-2), and fibrosis (0-4).\n2. Nonalcoholic steatohepatitis(NASH): when steatosis is present and when both features of activity (ballooning and lobular inflammation) display at least grade 1\n3. Unit: None'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Magnetic resonance imager(MRI)', 'Nonalcoholic fatty liver disease(NAFLD)', 'Imaging diagnostic'], 'conditions': ['Nonalcoholic Steatohepatitis']}, 'referencesModule': {'references': [{'pmid': '22488764', 'type': 'BACKGROUND', 'citation': 'Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available.'}, {'pmid': '22343514', 'type': 'BACKGROUND', 'citation': "Poynard T, Lenaour G, Vaillant JC, Capron F, Munteanu M, Eyraud D, Ngo Y, M'Kada H, Ratziu V, Hannoun L, Charlotte F. Liver biopsy analysis has a low level of performance for diagnosis of intermediate stages of fibrosis. Clin Gastroenterol Hepatol. 2012 Jun;10(6):657-63.e7. doi: 10.1016/j.cgh.2012.01.023. Epub 2012 Feb 14."}, {'pmid': '24036007', 'type': 'BACKGROUND', 'citation': 'Banerjee R, Pavlides M, Tunnicliffe EM, Piechnik SK, Sarania N, Philips R, Collier JD, Booth JC, Schneider JE, Wang LM, Delaney DW, Fleming KA, Robson MD, Barnes E, Neubauer S. Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol. 2014 Jan;60(1):69-77. doi: 10.1016/j.jhep.2013.09.002. Epub 2013 Sep 12.'}, {'pmid': '24853467', 'type': 'BACKGROUND', 'citation': 'Park YS, Lee CH, Kim JH, Kim BH, Kim JH, Kim KA, Park CM. Effect of Gd-EOB-DTPA on hepatic fat quantification using high-speed T2-corrected multi-echo acquisition in (1)H MR spectroscopy. Magn Reson Imaging. 2014 Sep;32(7):886-90. doi: 10.1016/j.mri.2014.04.010. Epub 2014 Apr 24.'}, {'pmid': '7560864', 'type': 'BACKGROUND', 'citation': 'Ishak K, Baptista A, Bianchi L, Callea F, De Groote J, Gudat F, Denk H, Desmet V, Korb G, MacSween RN, et al. Histological grading and staging of chronic hepatitis. J Hepatol. 1995 Jun;22(6):696-9. doi: 10.1016/0168-8278(95)80226-6. No abstract available.'}, {'pmid': '10484010', 'type': 'BACKGROUND', 'citation': 'Brunt EM, Janney CG, Di Bisceglie AM, Neuschwander-Tetri BA, Bacon BR. Nonalcoholic steatohepatitis: a proposal for grading and staging the histological lesions. Am J Gastroenterol. 1999 Sep;94(9):2467-74. doi: 10.1111/j.1572-0241.1999.01377.x.'}, {'pmid': '14498313', 'type': 'BACKGROUND', 'citation': 'SCHEUER PJ, WILLIAMS R, MUIR AR. Hepatic pathology in relatives of patients with haemochromatosis. J Pathol Bacteriol. 1962 Jul;84:53-64. No abstract available.'}, {'pmid': '15915461', 'type': 'BACKGROUND', 'citation': 'Kleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. doi: 10.1002/hep.20701.'}, {'pmid': '21092095', 'type': 'BACKGROUND', 'citation': "Piechnik SK, Ferreira VM, Dall'Armellina E, Cochlin LE, Greiser A, Neubauer S, Robson MD. Shortened Modified Look-Locker Inversion recovery (ShMOLLI) for clinical myocardial T1-mapping at 1.5 and 3 T within a 9 heartbeat breathhold. J Cardiovasc Magn Reson. 2010 Nov 19;12(1):69. doi: 10.1186/1532-429X-12-69."}]}, 'descriptionModule': {'briefSummary': '1. To evaluate feasibility of using multiparametric Magnetic resonance(MR) imaging to predict nonalcoholic steatohepatitis(NASH)\n2. To develop non-invasive diagnosis tool using multiparametric Magnetic resonance(MR) imaging for nonalcoholic steatohepatitis(NASH)', 'detailedDescription': 'Nonalcoholic steatohepatitis(NASH) is a severe form of nonalcoholic fatty liver disease(NAFLD). The causes are known to be associated with metabolic diseases such as obesity, insulin resistance type 2 diabetes, and hypercholesterolemia. Histologically, it is characterized by steatosis, hepatocellular injury, and inflammation and fibrosis of the liver parenchyma. Nonalcoholic steatohepatitis (NASH) may progress to cirrhosis and hepatocellular carcinoma(HCC) may develop even in patients without viral hepatitis, therefore there have been much interest and many researches in causation and diagnosis for nonalcoholic steatohepatitis(NASH).\n\nLiver biopsy remains the gold standard for the diagnosis of nonalcoholic fatty liver disease(NAFLD) and is the only reliable method for differentiating nonalcoholic steatohepatitis(NASH) from simple steatosis. However, liver biopsy has several drawbacks, including invasiveness, potential complications such as excessive bleeding and death, sampling error, and inter- and intra-observer variability.\n\nMagnetic resonance(MR) imaging has been used as a multiparametric imaging tool with which to evaluate steatosis by chemical shift imaging andm magnetic resonance(MR) spectroscopy, and fibrosis by magnetic resonance(MR) elastography and T1 mapping. To the best of our knowledge, there is no accurate imaging diagnostic tool for nonalcoholic steatohepatitis(NASH), therefore the investigators aimed to develop non-invasive imaging diagnostic model using multiparametric magnetic resonance imager(MRI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients \\>19 years age\n2. Patients who had elevated aspartate transaminase(AST)/alanine transaminase(ALT) and fatty liver on abdominal ultrasonography\n3. Patients who are clinically suspected to have nonalcoholic steatohepatitis(NASH)\n\n * Clinically suspected nonalcoholic steatohepatitis(NASH): \\>40 years age, metabolic syndrome, fibrosis on transient elastography(TE, Fibroscan), or elevated Fibrosis-4(FIB-4), Aspartate aminotransferase-to-platelet ratio index(APRI), nonalcoholic fatty liver disease fibrosis score(NFS) on blood tests\n4. Patients who underwent (\\<6 months) or will undergo US-guided liver biopsy\n\nExclusion Criteria:\n\n1. Chronic liver disease other than nonalcoholic fatty liver disease(NAFLD) (chronic hepatitis B or C, autoimmune hepatitis, primary biliary sclerosis)\n2. Alcohol abuse (men, \\>140g/week; women, \\>70g/week)\n3. Fatty liver due to medication\n4. Contraindication to magnetic resonance imager(MRI)\n5. Hepatocellular carcinoma\n6. Pregnancy'}, 'identificationModule': {'nctId': 'NCT03375008', 'briefTitle': 'Predictable MR Index for Nonalcoholic Steatohepatitis (NASH)', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Guro Hospital'}, 'officialTitle': 'Development of Non-invasive Magnetic Resonance Imaging Diagnostic Method for Nonalcoholic Steatohepatitis(NASH)', 'orgStudyIdInfo': {'id': 'KUGH16184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imaging diagnostic and biopsy', 'description': '47 subjects who are suspected NASH from June 2016 to December 2017.', 'interventionNames': ['Diagnostic Test: Imaging diagnostic and biopsy']}], 'interventions': [{'name': 'Imaging diagnostic and biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Liver biopsy and MRI scan', 'armGroupLabels': ['Imaging diagnostic and biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08308', 'city': 'Seoul', 'state': 'Guro-gu', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chang Hee Lee, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chang Hee Lee', 'investigatorAffiliation': 'Korea University Guro Hospital'}}}}