NCT07270601

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 )

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: ContextVision AB · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The objective is to develop a novel multiparametric ultrasound-based technique to quantify the amount of steatosis in the liver by using the current MRI-based gold-standard - MRI proton density fat fraction (MRI-PDFF) as a clinical reference. This clinical development study will only collect the required dataset from healthy volunteers and subjects with different degrees of steatosis in the liver, particularly patients with MASLD, formerly non-alcoholic fatty liver disease (NAFLD). It will capture the raw radiofrequency data required for the development of this new radiologic biomarker on a research ultrasound imaging device. In addition, various other clinical and radiological datasets will be captured to support the ground truthing, development and training of the novel ultrasound-based multiparametric biomarker.

Conditions

• MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
• NAFLD - Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DEVICE	Verasonics NXT Data Acquisition System	A research ultrasound imaging device to capture raw radiofrequency ultrasound data for the following parameters: * B-mode imaging * Attenuation coefficient * Backscatter coefficient * Speed of sound * Shear wave elastography
DEVICE	Philips EPIQ Elite	A premium ultrasound system with software package to support imaging research studies.
DEVICE	EchoSense FibroScan	A non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis.
DEVICE	Philips 3T Ingenia Elition	A 3-tesla magnetic resonance imaging (MRI) system

Timeline

• Start date: 2025-11-17
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study