NCT07270601Recruiting
Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis
Development and Diagnostic Evaluation of a Novel Quantifiable Ultrasound Based Multi-parametric Biomarker for Hepatic Steatosis in Patients With Suspected MASLD ( LYNX )
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 17 Nov 2025
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- ContextVision AB
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07270601
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 17 Nov 2025 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to MRI including, but not limited to, severe claustrophobia, pacemaker, or existing metallic/mechanical implant(s).
Other illness
- Acute illness/cognitive impairment resulting in an inability to cooperate with the MRI and ultrasound breath-holding instructions.
- 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.
- Known active cancer
Other
- Pregnancy or nursing.
- BMI \> 35 kg/m2
- Presence of known congenital hepatic anomaly.
- Known cirrhosis
Who the study is looking for
- 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.)
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.