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Recruiting NCT07270601

Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis

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Plain-language summary for patients

Trial Parameters

Condition MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Sponsor ContextVision AB
Study Type INTERVENTIONAL
Phase N/A
Enrollment 110
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-11-17
Completion 2026-10-31
Interventions
Verasonics NXT Data Acquisition SystemPhilips EPIQ EliteEchoSense FibroScan

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Brief Summary

The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic liver disease (MASLD). Current tests, like MRI or biopsy, can be expensive or invasive. If successful, this ultrasound tool could become an easier and more accessible way to monitor liver health - especially for people with obesity, diabetes, high blood pressure, or high cholesterol.

Eligibility Criteria

Inclusion Criteria: Diseased subject: * Adult patients (age 18 - 75 years) * Consent to participate in the study * Diagnosed or suspected MASLD from the hepatology clinic, OR * High-risk population meeting the adult cardiometabolic criteria (defined as the presence of at least one of the following: diabetes, obesity (BMI ≥ 25 kg/m2), hypercholesterolemia, and hypertension) Healthy volunteer: * Adult patients (age 18 - 75 years) * Consent to participate in the study * No suspicion of MASLD by laboratory/imaging/clinical examinations * Absence of known pre-existing conditions (metabolic syndrome, diabetes mellitus, obesity, insulin resistance, dyslipidemia, etc.) Exclusion Criteria: * Pregnancy or nursing. * Contraindications to MRI including, but not limited to, severe claustrophobia, pacemaker, or existing metallic/mechanical implant(s). * Acute illness/cognitive impairment resulting in an inability to cooperate with the MRI and ultrasound breath-holding instructions. * BMI \> 35 kg/m2

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