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NCT Number: NCT07189650

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI

Device

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

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

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Matteo Garcovich, MD, PhD

CONTACT

[email protected]

+39 0630156018

Sponsors and collaborators

Lead sponsor

Esaote S.p.A.

Industry

Registry information

Official study 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)

Acronym: QAI_QSI_MRI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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