LYNXNovel Ultrasound Biomarker for Hepatic Steatosis in MASLD
This study aims to evaluate if a new ultrasound method can accurately diagnose liver fat in individuals with metabolic associated steatotic liver disease by comparing it to a standard MRI test.
Verasonics NXT Data Acquisition System
+ Philips EPIQ Elite
+ EchoSense FibroScan
Digestive System Diseases+4
+ Fatty Liver
+ Fibrosis
Diagnostic Study
Summary
Study start date: November 17, 2025
Actual date on which the first participant was enrolled.This study focuses on creating a new way to measure fat in the liver using ultrasound technology. It targets people who may have MASLD, previously known as non-alcoholic fatty liver disease, as well as healthy individuals. The goal is to make liver fat measurement easier and more accessible by comparing the new ultrasound method to the current standard, which uses MRI. Understanding liver fat levels can help in diagnosing and managing liver diseases better. Participants will undergo ultrasound scans that collect detailed data needed to develop this new diagnostic tool. The study compares the results from the ultrasound with those from MRI to ensure accuracy. The primary outcome is to see how well the new ultrasound technique matches the MRI results, focusing on the percentage of liver fat measured. This research aims to validate the new method, providing a reliable, potentially more convenient option for assessing liver health.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.110 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location