Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study

NCT ID: NCT04657523

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2023-01-18

Brief Summary

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Investigational Ultrasound Imaging for Liver Fat Quantification

Group Type: EXPERIMENTAL

Investigational Liver Fat Quantification Software

Intervention Type: DEVICE

All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.

Interventions

Investigational Liver Fat Quantification Software

All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony E. Samir, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Stephan Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Richard G Barr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radiology Consultants, Inc

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Radiology Consultants, Inc

Boardman, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

US-GIS-10481

Identifier Type: -

Identifier Source: org_study_id