Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study

Philips

Status: Completed

Conditions: Non-Alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease

Treatments: Device: Investigational Liver Fat Quantification Software

Study type: Interventional

Funder types: Industry

Identifiers

NCT04657523

US-GIS-10481

Details and patient eligibility

About

This clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed with Nonalcoholic Fatty Liver Disease (NAFLD). The primary objective of this clinical study is to evaluate the clinical feasibility of an investigational ultrasound technique for quantifying liver fat by comparing specific ultrasound-derived biomarkers with the liver fat percentage obtained from MRI Proton Density Fat Fraction (MRI-PDFF) measurements. All subjects enrolled in this study will undergo two investigational abdominal ultrasound examinations using the Philips EPIQ Ultrasound System and one MRI PDFF examination according to the clinical standard of care.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be at least 18 years old and able to provide written informed consent
• Must attest to absent or minimal alcohol consumption (i.e. < 2 alcoholic beverages per day for women and < 3 alcoholic beverages per day for men, where an alcoholic beverage is defined as 12 oz. of regular beer, 5 oz. of wine, or 1.5 oz. of distilled spirits).
• Must be eligible for a standard abdominal ultrasound examination and standard non-contrast MRI examination.
• At least one of the following criteria must also be met: Overweight or obese (BMI ≥ 25); Diagnosed with Type 2 diabetes; Diagnosed with hypercholesterolemia; Diagnosed with or clinically suspected of having NAFLD/NASH

Exclusion criteria

• Evidence of moderate/heavy/binge alcohol consumption exceeding the thresholds above
• Evidence of hepatotoxicity
• History of chronic liver disease (e.g., viral, cholestatic, or autoimmune).
• Use of drugs associated with hepatic steatosis
• Subjects anticipated or planned to undergo any diagnostic or therapeutic intervention during enrollment period that, at discretion of the Investigator, may affect liver fat content
• Hepatic lesions that cannot be excluded from the imaging field during ultrasound LFQ data acquisition
• History of previous liver surgery or hepatic implants that, at the discretion of the Investigator, may adversely impact ultrasound or MRI image quality or the subject's eligibility to undergo ultrasound or MRI

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Investigational Ultrasound Imaging for Liver Fat Quantification

Experimental group

Treatment:

Device: Investigational Liver Fat Quantification Software