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

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Investigational Liver Fat Quantification Software

About this trial

This is an interventional diagnostic trial for Non-Alcoholic Fatty Liver Disease focused on measuring Liver Fat Quantification, Ultrasound, Liver Disease, Digestive System Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital
Boston Medical Center
Radiology Consultants, Inc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational Ultrasound Imaging for Liver Fat Quantification

Arm Description

Outcomes

Primary Outcome Measures

Correlation of the liver fat percentage reported from MRI-PDFF with measurements of ultrasound biomarkers for liver fat.

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

Inter-operator variability in measurements of ultrasound biomarkers for liver fat

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

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.

Full Information

NCT ID

NCT04657523

First Posted

November 20, 2020

Last Updated

January 31, 2023

Sponsor

Philips Clinical & Medical Affairs Global

1. Study Identification

Unique Protocol Identification Number

NCT04657523

Brief Title

Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study

Acronym

LFQ

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

October 30, 2020 (Actual)

Primary Completion Date

January 18, 2023 (Actual)

Study Completion Date

January 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Philips Clinical & Medical Affairs Global

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis

Keywords

Liver Fat Quantification, Ultrasound, Liver Disease, Digestive System Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Investigational Ultrasound Imaging for Liver Fat Quantification

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Investigational Liver Fat Quantification Software

Intervention Description

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.

Primary Outcome Measure Information:

Title

Correlation of the liver fat percentage reported from MRI-PDFF with measurements of ultrasound biomarkers for liver fat.

Description

Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF will be assessed independently to evaluate individual biomarker performance.

Time Frame

Intra-procedural (1 day)

Secondary Outcome Measure Information:

Title

Inter-operator variability in measurements of ultrasound biomarkers for liver fat

Description

Inter-operator variability will be assessed by comparing the ultrasound biomarkers measured from each subject by two different operators who have received standardized training.

Time Frame

Intra-procedural (1 day)

Title

Ultrasound biomarker measurement failure rate

Description

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.

Time Frame

Intra-procedural (1 day)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony E. Samir, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stephan Anderson, MD

Organizational Affiliation

Boston Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Richard G Barr, MD, PhD

Organizational Affiliation

Radiology Consultants, Inc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

Radiology Consultants, Inc

City

Boardman

State/Province

Ohio

ZIP/Postal Code

44512

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study

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