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

Official title

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)

Overview

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

Detailed description

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

Interventions

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

Primary outcome measures

• 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 [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07189650 · CIP000004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗