N/A
N=60
Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study
Non-Alcoholic Fatty Liver Disease · Non-Alcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT04657523 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements Hepatorenal Index (HRI) of Ultrasound Biomarkers for Liver Fat. — 1.6 Hepatorenal Index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational Liver Fat Quantification Software (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Philips Clinical & Medical Affairs Global
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements Hepatorenal Index (HRI) of Ultrasound Biomarkers for Liver Fat. |
1.6 | — |
| PRIMARY Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Acoustic Attenuation (dB/cm/MHZ) Ultrasound Biomarker for Liver Fat. |
1.0 | — |
| PRIMARY Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarker for Liver Fat. |
5.9 | — |
| SECONDARY To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker "Hepatorenal Index (HRI)" |
-0.1 | — |
| SECONDARY To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker "Hepatorenal Index (HRI)" |
1 | — |
| SECONDARY To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ) |
— | — |
| SECONDARY To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Tissue Stiffness (kPa) |
1 | — |
| SECONDARY To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ) |
0.0 | — |
| SECONDARY To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Tissue Stiffness (kPa) |
0.1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04657523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.