Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study
- Conditions
- Non-Alcoholic Fatty Liver DiseaseNon-Alcoholic Steatohepatitis
- Interventions
- Device: Investigational Liver Fat Quantification Software
- Registration Number
- NCT04657523
- Lead Sponsor
- Philips Clinical & Medical Affairs Global
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Investigational Ultrasound Imaging for Liver Fat Quantification Investigational Liver Fat Quantification Software -
- Primary Outcome Measures
Name Time Method Correlation of the liver fat percentage reported from MRI-PDFF with measurements of ultrasound biomarkers for liver fat. Intra-procedural (1 day) Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF will be assessed independently to evaluate individual biomarker performance.
- Secondary Outcome Measures
Name Time Method Inter-operator variability in measurements of ultrasound biomarkers for liver fat Intra-procedural (1 day) Inter-operator variability will be assessed by comparing the ultrasound biomarkers measured from each subject by two different operators who have received standardized training.
Ultrasound biomarker measurement failure rate Intra-procedural (1 day) The ultrasound biomarker measurement failure rate will be assessed by measuring the percentage of subjects in whom measurements cannot be made due to technical limitations.
Trial Locations
- Locations (3)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Radiology Consultants, Inc
🇺🇸Boardman, Ohio, United States