Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis (LYNX)

ContextVision AB

Status: Enrolling

Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; NAFLD - Non-Alcoholic Fatty Liver Disease

Treatments: Device: Philips EPIQ Elite; Device: Verasonics NXT Data Acquisition System; Device: Philips 3T Ingenia Elition; Device: EchoSense FibroScan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07270601

COV-POCUS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Cohort

Experimental group

Description:

Adult healthy volunteers as well as subjects who have a diagnosis, or suspected, of having MASLD or are deemed to meet the high-risk cardiometabolic criteria.

Treatment:

Device: EchoSense FibroScan

Device: Philips 3T Ingenia Elition

Device: Verasonics NXT Data Acquisition System

Device: Philips EPIQ Elite