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NCT07189650

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

Sponsor: Esaote S.p.A.

View on ClinicalTrials.gov

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

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-09-30

Completion Date

2026-04-30

Last Updated

2025-09-24

Healthy Volunteers

No

Interventions

DEVICE

MRI

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