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OpenTrials
Completed

NCT Number: NCT04523584

Ultrasound Quantification of Liver Fat

The investigators plan a prospective study designed to evaluate the accuracy of a new ultrasound method for quantification of liver fat content.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Device

Participants will undergo MR imaging of the liver. Liver PDFF will be measured.

Ultrasound Imaging

Device

Participants will undergo ultrasound imaging of the liver. UDFF and shear wave speed (US-SWS) will be measured.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Siemens Medical Solutions

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Aug 21, 2020
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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