Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis

Recruiting now · Not applicable

Conditions studied: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease

In brief

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.

Key facts

Study ID

NCT07270601

Run by

ContextVision AB

People needed

110

Starts

2025-11-17

Expected to finish

2026-12-31

Last updated by the study team

2025-12-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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
• History of excessive alcohol consumption according to the updated MASLD criteria (>2 drinks/day OR >210 grams/week for males AND >1 drink/day OR >140 grams/week for females) or drug use over the past 2 years.
• Known acute or chronic hepatitis; or other etiology of liver disease.
• Presence of known congenital hepatic anomaly.
• Known cirrhosis
• Known active cancer

Where it is running

• University of Washington — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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