Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study (LFQ)

Pilot Study of On-Cart Liver Fat Quantification (LFQ) Feature to Assess Correlation With Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) Results

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.

Study Overview

• Status: Completed
• Conditions: Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis
• Intervention / Treatment: Device: Investigational Liver Fat Quantification Software

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Radiology Consultants, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Ultrasound Imaging for Liver Fat Quantification	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements Hepatorenal Index (HRI) of Ultrasound Biomarkers for Liver Fat.	For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. The difference between the two operators was calculated at the subject level by averaging multiple measurements. To assess the correlation between measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. A higher HRI value indicates greater liver fat accumulation, which reflects a worse outcome, while a lower HRI suggests less hepatic fat and a better outcome.	Intra-procedural (1 day)
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Acoustic Attenuation (dB/cm/MHZ) Ultrasound Biomarker for Liver Fat.	For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. To assess the correlation between subject averaged measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF is assessed independently to evaluate individual biomarker performance. A higher attenuation value indicates worse liver condition, while a lower attenuation value suggests better liver status.	Intra-procedural (1 day)
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarker for Liver Fat.	For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. To assess the correlation between subject averaged measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. This measured the MRI PDFF fat fraction used as the standard to evaluate the Tissue stiffness (kPa) measurements. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF is assessed independently to evaluate individual biomarker performance.	Intra-procedural (1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker "Hepatorenal Index (HRI)"	To assess the difference in quantitative ultrasound biomarker measurements which acquired from the same subject on the same day by two different operators who have undergone standardized training for LFQ data acquisition. The difference between the two operators was calculated at the subject level by averaging multiple measurements. A higher HRI value indicates greater liver fat accumulation, which reflects a worse outcome, while a lower HRI suggests less hepatic fat and a better outcome.	Intra-procedural (1 day)
To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker "Hepatorenal Index (HRI)"	To evaluate the LFQ data acquisition failure rate, the proportion of subjects who have at least one unacceptable image quality due to inadequate acoustic scanning windows, motion artifacts, or other technical limitations	Intra-procedural (1 day)
To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ)	To evaluate the LFQ data acquisition failure rate, the proportion of subjects who have at least one unacceptable image quality due to inadequate acoustic scanning windows, motion artifacts, or other technical limitations	Intra-procedural (1 day)
To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Tissue Stiffness (kPa)	To evaluate the LFQ data acquisition failure rate, the proportion of subjects who have at least one unacceptable image quality due to inadequate acoustic scanning windows, motion artifacts, or other technical limitations	Intra-procedural (1 day)
To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ)	To assess the difference in quantitative ultrasound biomarker measurements which acquired from the same subject on the same day by two different operators who have undergone standardized training for LFQ data acquisition. The difference between the two operators was calculated at the subject level by averaging multiple measurements.	Intra-procedural (1 day)
To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Tissue Stiffness (kPa)	To assess the difference in quantitative ultrasound biomarker measurements which acquired from the same subject on the same day by two different operators who have undergone standardized training for LFQ data acquisition. The difference between the two operators was calculated at the subject level by averaging multiple measurements.	Intra-procedural (1 day)

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Principal Investigator: Anthony E. Samir, MD, Massachusetts General Hospital; Principal Investigator: Stephan Anderson, MD, Boston Medical Center; Principal Investigator: Richard G Barr, MD, PhD, Radiology Consultants, Inc

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): January 18, 2023
• Study Completion (Actual): January 18, 2023

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Liver Disease; Digestive System Disease; Liver Fat Quantification
• Additional Relevant MeSH Terms: Fatty Liver; Digestive System Diseases; Liver Diseases; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: US-GIS-10481

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No