Clinical Trial

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

Study acronym: QAI_QSI_MRI
Not Yet Recruiting
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Record status
This record was last updated September 24, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.
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
Trial Details
NCT Number NCT07189650
Lead Sponsor Esaote S.p.A.
Conditions Metabolic Dysfunction-Associated Liver Disease
Enrollment 30 participants
Start Date 2025-09-30
Primary Completion 2026-03-31 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-24