Clinical trial NCT04657523: Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study
Official title: Pilot Study of On-Cart Liver Fat Quantification (LFQ) Feature to Assess Correlation With Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Non-Alcoholic Steatohepatitis
Keywords: Liver Fat Quantification
Ultrasound
Liver Disease
Digestive System Disease
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2020-12-08
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Correlation of the liver fat percentage reported from MRI-PDFF with measurements of ultrasound biomarkers for liver fat.
timeFrame: Intra-procedural (1 day)
Secondary outcomes:
measure: Inter-operator variability in measurements of ultrasound biomarkers for liver fat
timeFrame: Intra-procedural (1 day)
measure: Ultrasound biomarker measurement failure rate
timeFrame: Intra-procedural (1 day)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boardman
country: United States
facility: Radiology Consultants, Inc
state: Ohio
Study officials:
affiliation: Massachusetts General Hospital
name: Anthony E. Samir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Stephan Anderson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiology Consultants, Inc
name: Richard G Barr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: