Pilot Study for Collecting Data on Liver Adipose Content in Adults by Ultrasound Attenuation and Scattering Imaging and MRI Proton-density

NCT07189650 | Not Yet Recruiting FDA Device

• 1 other identifier: CIP000004
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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). Ultrasound attenuation (QAI) and scattering (QSI) imaging parameters will be acquired. Fat 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. The 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). Eligible 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

Conditions

Metabolic Dysfunction-Associated Liver Disease

Keywords

Metabolic Dysfunction-Associated Liver Disease,; MASLD; Ultrasound - Tissue attenuation Imaging; Ultrasound - Tissue scatter imaging; MRI - Proton Density Fat Fraction; QAI; QSI; MRI-PDFF

Outcome Measures

Primary Outcomes (1)

• 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

  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

  through study completion, an average of 1 year

Study Arms (1)

Single Cohort

not vulnerable, adult subjetcs affected by MASLD (Metabolic Dysfunction-Associated Liver Disease)

Device: MRI

Interventions

MRI DEVICE

Proton Density Fat Fraction Magnetic Resonance Imaging (MRI-PDFF )

Single Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients affected by MASLD (Metabolic Dysfunction-Associated Liver Disease)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• Contraindications to MRI (patients with a pacemaker, metal implants, pregnant patients, claustrophobia, physical inability to perform the exam due to constitution);
• Inappropriate alcohol consumption (\>30 g/day for men and \>20 g/day for women);
• Viral liver disease (HBV, HCV, HIV);
• Other forms of metabolic/autoimmune/cholestatic or storage liver disease e.g., primary biliary cholangitis, sclerosing cholangitis, hemochromatosis, Wilson's disease);
• History of hepatocellular carcinoma or other forms of malignancy;
• Refusal to participate in the study.

Sponsors & Collaborators

• Esaote S.p.A.: lead

Related Publications (13)

• 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: 29359454 BACKGROUND

• 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: 23696515 BACKGROUND

• 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: 34284932 BACKGROUND

• 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: 19243014 BACKGROUND

• 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: 16707372 BACKGROUND

• 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: 19846234 BACKGROUND

• 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: 34815553 BACKGROUND

• 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: 31158374 BACKGROUND

• 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: 24042449 BACKGROUND

• 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: 27062661 BACKGROUND

• 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: 26819531 BACKGROUND

• 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: 27543837 BACKGROUND

• 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.

  PMID: 15565570 BACKGROUND

Study Officials

• Matteo Garcovich, MD, PhD

  UOSD Ecografia Diagnostica e Interventistica - Fondazione Policlinico Universitario Gemelli IRCCS, Rome (Italy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Garcovich, MD, PhD

CONTACT

+39 0630156018; matteo.garcovich@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 24, 2025
• Study Start: September 30, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share