Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 12:27 AM
Study NCT ID:
NCT07189650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study for Collecting Data on Liver Adipose Content in Adults by Ultrasound Attenuation and Scattering Imaging and MRI Proton-density
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-19', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exploratory comparison of Ultrasound Imaging findings (Tissue Attenuation Imaging and Tissue Scatter Imaging) with MRI one (MRI-PDFF, considered as reference) in evaluating liver adipose content', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Exploratory and preliminary comparison of the findings obtained assessing liver adipose content in a population of adult patients affected by MASLD (Metabolic Dysfunction-Associated Liver Disease) utilizing Ultrasound Imaging (Tissue Attenuation Imaging and Tissue Scatter Imaging) technologies and MRI one (MRI-PDFF). The latter is considered as reference technology and gold standard'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Metabolic Dysfunction-Associated Liver Disease,', 'MASLD', 'Ultrasound - Tissue attenuation Imaging', 'Ultrasound - Tissue scatter imaging', 'MRI - Proton Density Fat Fraction', 'QAI', 'QSI', 'MRI-PDFF'], 'conditions': ['Metabolic Dysfunction-Associated Liver Disease']}, 'referencesModule': {'references': [{'pmid': '29359454', 'type': 'BACKGROUND', 'citation': "Han A, Andre MP, Deiranieh L, Housman E, Erdman JW Jr, Loomba R, Sirlin CB, O'Brien WD Jr. Repeatability and Reproducibility of the Ultrasonic Attenuation Coefficient and Backscatter Coefficient Measured in the Right Lobe of the Liver in Adults With Known or Suspected Nonalcoholic Fatty Liver Disease. J Ultrasound Med. 2018 Aug;37(8):1913-1927. doi: 10.1002/jum.14537. Epub 2018 Jan 23."}, {'pmid': '23696515', 'type': 'BACKGROUND', 'citation': 'Noureddin M, Lam J, Peterson MR, Middleton M, Hamilton G, Le TA, Bettencourt R, Changchien C, Brenner DA, Sirlin C, Loomba R. Utility of magnetic resonance imaging versus histology for quantifying changes in liver fat in nonalcoholic fatty liver disease trials. Hepatology. 2013 Dec;58(6):1930-40. doi: 10.1002/hep.26455. Epub 2013 Oct 17.'}, {'pmid': '34284932', 'type': 'BACKGROUND', 'citation': 'Ferraioli G, Berzigotti A, Barr RG, Choi BI, Cui XW, Dong Y, Gilja OH, Lee JY, Lee DH, Moriyasu F, Piscaglia F, Sugimoto K, Wong GL, Wong VW, Dietrich CF. Quantification of Liver Fat Content with Ultrasound: A WFUMB Position Paper. Ultrasound Med Biol. 2021 Oct;47(10):2803-2820. doi: 10.1016/j.ultrasmedbio.2021.06.002. Epub 2021 Jul 18.'}, {'pmid': '19243014', 'type': 'BACKGROUND', 'citation': 'Rockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD; American Association for the Study of Liver Diseases. Liver biopsy. Hepatology. 2009 Mar;49(3):1017-44. doi: 10.1002/hep.22742. No abstract available.'}, {'pmid': '16707372', 'type': 'BACKGROUND', 'citation': 'Cholongitas E, Senzolo M, Standish R, Marelli L, Quaglia A, Patch D, Dhillon AP, Burroughs AK. A systematic review of the quality of liver biopsy specimens. Am J Clin Pathol. 2006 May;125(5):710-21. doi: 10.1309/W3XC-NT4H-KFBN-2G0B.'}, {'pmid': '19846234', 'type': 'BACKGROUND', 'citation': 'Dasarathy S, Dasarathy J, Khiyami A, Joseph R, Lopez R, McCullough AJ. Validity of real time ultrasound in the diagnosis of hepatic steatosis: a prospective study. J Hepatol. 2009 Dec;51(6):1061-7. doi: 10.1016/j.jhep.2009.09.001. Epub 2009 Sep 20.'}, {'pmid': '34815553', 'type': 'BACKGROUND', 'citation': 'Tamaki N, Ajmera V, Loomba R. Non-invasive methods for imaging hepatic steatosis and their clinical importance in NAFLD. Nat Rev Endocrinol. 2022 Jan;18(1):55-66. doi: 10.1038/s41574-021-00584-0. Epub 2021 Nov 23.'}, {'pmid': '31158374', 'type': 'BACKGROUND', 'citation': 'Eslam M, Sanyal AJ, George J. Toward More Accurate Nomenclature for Fatty Liver Diseases. Gastroenterology. 2019 Sep;157(3):590-593. doi: 10.1053/j.gastro.2019.05.064. Epub 2019 May 31. No abstract available.'}, {'pmid': '24042449', 'type': 'BACKGROUND', 'citation': 'Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.'}, {'pmid': '27062661', 'type': 'BACKGROUND', 'citation': 'European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available.'}, {'pmid': '26819531', 'type': 'BACKGROUND', 'citation': 'Ress C, Kaser S. Mechanisms of intrahepatic triglyceride accumulation. World J Gastroenterol. 2016 Jan 28;22(4):1664-73. doi: 10.3748/wjg.v22.i4.1664.'}, {'pmid': '27543837', 'type': 'BACKGROUND', 'citation': 'Younossi ZM, Blissett D, Blissett R, Henry L, Stepanova M, Younossi Y, Racila A, Hunt S, Beckerman R. The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe. Hepatology. 2016 Nov;64(5):1577-1586. doi: 10.1002/hep.28785. Epub 2016 Sep 26.'}, {'pmid': '15565570', 'type': 'BACKGROUND', 'citation': 'Browning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, Grundy SM, Hobbs HH. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004 Dec;40(6):1387-95. doi: 10.1002/hep.20466.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this single-center, prospective, pilot study is to acquire data on liver adipose content in a population of adult patients affected by MASLD (Metabolic Dysfunction-Associated Liver Disease).\n\nUltrasound attenuation (QAI) and scattering (QSI) imaging parameters will be acquired.\n\nFat percentage parameters, obtained from magnetic resonance imaging with proton density technique (MRI-PDFF), will be acquired as well and they will be considered as reference method and gold standard.\n\nThe study is initiated for exploratory and research purposes. The study will enroll 30 consecutive, non-vulnerable adult participants who are scheduled to undergo upper abdominal ultrasound (Intervention A) as part of their standard clinical evaluation for the diagnosis and/or management of steatotic liver disease (SLD).\n\nEligible participants will be invited to provide informed consent to undergo an additional, non-invasive imaging procedure (Intervention B), consisting of magnetic resonance imaging with proton density fat fraction (MRI-PDFF) quantification', 'detailedDescription': 'The primary endpoint of this exploratory study is to acquire data on liver adipose content in a population of adult patients affected by MASLD for comparing Ultrasound Imaging (QAI and QSI) and MRI (MRI-PDFF) methods'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients affected by MASLD (Metabolic Dysfunction-Associated Liver Disease)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Previous diagnosis or suspected steatosic liver disease. The diagnosis may be suspected in the presence of concomitant conditions, such as (but not limited to) obesity, type 2 diabetes, pro-atherogenic dyslipidemia (hypertriglyceridemia, low HDL cholesterol), and metabolic syndrome;\n* Patients for whom an upper abdominal ultrasound is indicated as part of the clinical workup for the diagnosis and/or treatment of steatosic liver disease.\n\nExclusion Criteria:\n\n* Contraindications to MRI (patients with a pacemaker, metal implants, pregnant patients, claustrophobia, physical inability to perform the exam due to constitution);\n* Inappropriate alcohol consumption (\\>30 g/day for men and \\>20 g/day for women);\n* Viral liver disease (HBV, HCV, HIV);\n* Other forms of metabolic/autoimmune/cholestatic or storage liver disease e.g., primary biliary cholangitis, sclerosing cholangitis, hemochromatosis, Wilson's disease);\n* History of hepatocellular carcinoma or other forms of malignancy;\n* Refusal to participate in the study."}, 'identificationModule': {'nctId': 'NCT07189650', 'acronym': 'QAI_QSI_MRI', 'briefTitle': 'Pilot Study for Collecting Data on Liver Adipose Content in Adults by Ultrasound Attenuation and Scattering Imaging and MRI Proton-density', 'organization': {'class': 'INDUSTRY', 'fullName': 'Esaote S.p.A.'}, 'officialTitle': 'Collection of Quantitative Data on Liver Fat Content Obtained From Ultrasound Attenuation (QAI) and Scattering (QSI) Imaging and From Liver Fat Fraction Values Obtained by Magnetic Resonance Imaging With Proton Density Technique (MRI-PDFF)', 'orgStudyIdInfo': {'id': 'CIP000004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single Cohort', 'description': 'not vulnerable, adult subjetcs affected by MASLD (Metabolic Dysfunction-Associated Liver Disease)', 'interventionNames': ['Device: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'Proton Density Fat Fraction Magnetic Resonance Imaging (MRI-PDFF )', 'armGroupLabels': ['Single Cohort']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Matteo Garcovich, MD, PhD', 'role': 'CONTACT', 'email': 'matteo.garcovich@policlinicogemelli.it', 'phone': '+39 0630156018'}], 'overallOfficials': [{'name': 'Matteo Garcovich, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UOSD Ecografia Diagnostica e Interventistica - Fondazione Policlinico Universitario Gemelli IRCCS, Rome (Italy)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared with other researchers as this is a pilot-exploratory study that seek to generate hypotheses rather than a confirmatory study testing a specific, predetermined hypothesis with the goal of providing conclusive evidence in support of it.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esaote S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}