Status:
NOT_YET_RECRUITING
Pilot Study for Collecting Data on Liver Adipose Content in Adults by Ultrasound Attenuation and Scattering Imaging and MRI Proton-density
Lead Sponsor:
Esaote S.p.A.
Conditions:
Metabolic Dysfunction-Associated Liver Disease
Eligibility:
All Genders
18+ years
Brief 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)...
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 (M...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07189650
Start Date
September 30 2025
End Date
April 30 2026
Last Update
September 24 2025
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