Ultrasound method to measure liver fat percentage
Official title: Development and Diagnostic Evaluation of a Novel Quantifiable Ultrasound Based Multi-parametric Biomarker for Hepatic Steatosis in Patients With Suspected MASLD ( LYNX )
Run by ContextVision AB · NCT07270601 · Data updated 2026-11-12
This study will test whether a new ultrasound technique can accurately measure the percentage of fat in the liver for adults with or at risk for MASLD (formerly NAFLD) and for healthy volunteers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | ContextVision AB Industry-sponsored |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | November 17, 2025 |
| Main results expected | October 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | December 8, 2025 |
| Trial ID | NCT07270601 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with diagnosed or suspected MASLD or who meet cardiometabolic risk criteria (diabetes, BMI ≥25 kg/m2, high cholesterol, or hypertension), as well as healthy volunteers without metabolic conditions, are the intended participants.
✕Probably not a fit
People who are pregnant or nursing, have BMI over 35, have MRI contraindications (e.g., pacemaker, severe claustrophobia, metallic implants), or cannot comply with breath-hold instructions are excluded and unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study will collect raw radiofrequency ultrasound data and standard clinical ultrasound images from healthy volunteers and adults with varying degrees of hepatic steatosis, using research and clinical ultrasound systems alongside FibroScan. MRI proton density fat fraction (MRI-PDFF) on a 3T scanner will be used as the reference standard to ground-truth liver fat measurements. Clinical and laboratory data will also be captured to support development and training of a multiparametric ultrasound biomarker. The goal is to develop and validate an ultrasound-based quantitative marker of steatosis that correlates with MRI-PDFF.
Why it matters
Potential benefit: If successful, this could provide a cheaper, non-invasive, and more widely available way to measure and monitor liver fat without routine use of MRI or biopsy.
How similar studies have gone: Prior ultrasound-based methods like FibroScan CAP and attenuation imaging have shown promise for estimating liver fat, but developing a multiparametric raw-RF ultrasound biomarker calibrated to MRI-PDFF is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 * 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's running
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University of Washington
Seattle, Washington, United States Recruiting
Study contacts
- Study coordinator: Laura Sissons-Ross Research Manager
- Email: lsissons@uw.edu
- Phone: 206-616-0397
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Low‑methoxy pectin for inflammation, gut microbiome, and metabolic health in MASLD
This tests whether taking daily low‑methoxy pectin for six weeks can reduce inflammation and improve gut bacteria and metabolic markers in adults with MASLD.
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See if a Mediterranean-style lifestyle program helps MASLD patients improve liver health
This trial tests a Mediterranean diet plus personalized exercise plan in adults with MASLD to see if it improves liver and systemic markers.
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Exercise for an Aging Liver
This study tests whether a supervised 12-week exercise program can reduce liver fat, inflammation, and fibrosis in adults with MASLD or at-risk MASH, comparing younger and older adults and different disease severities.
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Spleen stiffness measurement to detect advanced liver fibrosis
This study will test whether measuring spleen stiffness with a 100‑Hz probe can help detect advanced fibrosis and portal hypertension in adults with MASLD and compensated advanced chronic liver disease.
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Extra virgin olive oil for liver and metabolic health in MASLD
This trial will test whether taking extra virgin olive oil every day helps adults with MASLD and overweight reduce liver fat and improve blood sugar and cholesterol.
-
Pulsendo for Type 2 Diabetes and fatty liver disease in adults
This study tests the pulsENDO procedure in adults with type 2 diabetes who still have high blood sugar despite meds, to see if it helps their diabetes and fatty liver disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.