Ultrasound Quantification of Liver Fat

July 22, 2022 updated by: Children's Hospital Medical Center, Cincinnati
The investigators plan a prospective study designed to evaluate the accuracy of a new ultrasound method for quantification of liver fat content.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

MRI proton density fat fraction (PDFF) will serve as the reference standard for liver fat fraction measurements. The strength of agreement between ultrasound derived fat fraction (UDFF) and PDFF will be the outcome of interest for this study.

Study Type

Observational

Enrollment (Actual)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients 16 years of age or older with known fatty liver disease (based upon prior MRI or ultrasound), or at risk for fatty liver disease (obese).

Description

Inclusion Criteria:

  • Patients 16 years of age or older with known fatty liver disease (based upon prior MRI or ultrasound), or at risk for fatty liver disease (obese).

Exclusion Criteria:

  • Subject under the age of 16
  • Pregnant subject
  • Subjects who cannot cooperate with performance of the ultrasound exam
  • Subjects who cannot cooperate with performance of the MRI exam
  • Subjects who have contraindications to MRI
  • Subjects who might require sedation or anesthesia to undergo study imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepatic Steatosis
<5% liver fat fraction by MRI PDFF
Device: Magnetic Resonance Imaging (MRI)
Participants will undergo MR imaging of the liver. Liver PDFF will be measured.
Device: Ultrasound Imaging
Participants will undergo ultrasound imaging of the liver. UDFF and shear wave speed (US-SWS) will be measured.
No Hepatic Steatosis
>5% liver fat fraction by MRI PDFF
Device: Magnetic Resonance Imaging (MRI)
Participants will undergo MR imaging of the liver. Liver PDFF will be measured.
Device: Ultrasound Imaging
Participants will undergo ultrasound imaging of the liver. UDFF and shear wave speed (US-SWS) will be measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI PDFF correlation/agreement to UDFF
Time Frame: Single time point-30 minute MRI/30 minute Ultrasound
Liver fat % derived using MR PDFF will be compared to UDFF
Single time point-30 minute MRI/30 minute Ultrasound

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Siemens Medical Solutions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2016

Primary Completion (Actual)

December 14, 2020

Study Completion (Actual)

July 22, 2021

Study Registration Dates

First Submitted

August 14, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIN_US Liver Fat

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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