Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis
Recruiting · NCT07270601 · Interventional (participants receive a specific treatment) · Lead sponsor: ContextVision AB
View the official record on ClinicalTrials.gov →Interventions studied
EchoSense FibroScanPhilips 3T Ingenia ElitionPhilips EPIQ EliteVerasonics NXT Data Acquisition System
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- 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
1 location listed across 1 US state.
- University of Washington - Seattle, Washington, United States