Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study

NCT04657523 | Completed Results FDA Device

• 1 other identifier: US-GIS-10481
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Keywords

Liver Fat Quantification; Ultrasound; Liver Disease; Digestive System Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker "Hepatorenal Index (HRI)"

  Intra-procedural (1 day)

• To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker "Hepatorenal Index (HRI)"

  Intra-procedural (1 day)

• To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ)

  Intra-procedural (1 day)

• To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Tissue Stiffness (kPa)

  Intra-procedural (1 day)

• To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ)

  Intra-procedural (1 day)

Study Arms (1)

Investigational Ultrasound Imaging for Liver Fat Quantification

EXPERIMENTAL

Device: Investigational Liver Fat Quantification Software

Interventions

Investigational Liver Fat Quantification Software 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.

Investigational Ultrasound Imaging for Liver Fat Quantification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Radiology Consultants, Inc

Boardman, Ohio, 44512, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Fatty Liver

Results Point of Contact

• Title: Rob Johnson
• Organization: Philips Ultrasound LLC.

rob.johnson_1@philips.com

42527572756

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 8, 2020
• Study Start: October 30, 2020
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2024-10

Locations

US (3)