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

N/ANot Yet RecruitingNCT07189650

Esaote S.p.A.30 enrolled

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metabolic Dysfunction-Associated Liver Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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