Ultrasound method to measure liver fat percentage
Development and Diagnostic Evaluation of a Novel Quantifiable Ultrasound Based Multi-parametric Biomarker for Hepatic Steatosis in Patients With Suspected MASLD ( LYNX )
NA · ContextVision AB · NCT07270601
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | ContextVision AB (industry) |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT07270601 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seattle, Washington
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease, MASLD, NAFLD, Ultrasound, Steatosis, Fibrosis, MRI-PDFF