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NCT04523584 Clinical Trial

Ultrasound Quantification of Liver Fat

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:
Ultrasound Quantification of Liver Fat

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04523584
Other study ID # CIN_US Liver Fat
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 8, 2016
Est. completion date July 22, 2021

Study information
Verified date June 2022
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 192
Est. completion date July 22, 2021
Est. primary completion date December 14, 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Magnetic Resonance Imaging (MRI)
Participants will undergo MR imaging of the liver. Liver PDFF will be measured.
• Ultrasound Imaging
Participants will undergo ultrasound imaging of the liver. UDFF and shear wave speed (US-SWS) will be measured.

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (2)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati Siemens Medical Solutions

Country where clinical trial is conducted

United States, 

References & Publications (6)

Fierbinteanu Braticevici C, Sporea I, Panaitescu E, Tribus L. Value of acoustic radiation force impulse imaging elastography for non-invasive evaluation of patients with nonalcoholic fatty liver disease. Ultrasound Med Biol. 2013 Nov;39(11):1942-50. doi: 10.1016/j.ultrasmedbio.2013.04.019. Epub 2013 Aug 9. — View Citation

Hanquinet S, Rougemont AL, Courvoisier D, Rubbia-Brandt L, McLin V, Tempia M, Anooshiravani M. Acoustic radiation force impulse (ARFI) elastography for the noninvasive diagnosis of liver fibrosis in children. Pediatr Radiol. 2013 Mar;43(5):545-51. doi: 10.1007/s00247-012-2595-8. Epub 2012 Dec 28. — View Citation

Kinner S, Reeder SB, Yokoo T. Quantitative Imaging Biomarkers of NAFLD. Dig Dis Sci. 2016 May;61(5):1337-47. doi: 10.1007/s10620-016-4037-1. Epub 2016 Feb 5. Review. — View Citation

Middleton MS, Van Natta ML, Heba ER, Alazraki A, Trout AT, Masand P, Brunt EM, Kleiner DE, Doo E, Tonascia J, Lavine JE, Shen W, Hamilton G, Schwimmer JB, Sirlin CB; NASH Clinical Research Network. Diagnostic accuracy of magnetic resonance imaging hepatic proton density fat fraction in pediatric nonalcoholic fatty liver disease. Hepatology. 2018 Mar;67(3):858-872. doi: 10.1002/hep.29596. Epub 2018 Jan 26. — View Citation

Trout AT, Dillman JR, Xanthakos S, Kohli R, Sprague G, Serai S, Mahley AD, Podberesky DJ. Prospective Assessment of Correlation between US Acoustic Radiation Force Impulse and MR Elastography in a Pediatric Population: Dispersion of US Shear-Wave Speed Measurement Matters. Radiology. 2016 Nov;281(2):544-552. Epub 2016 May 26. — View Citation

Tyagi A, Yeganeh O, Levin Y, Hooker JC, Hamilton GC, Wolfson T, Gamst A, Zand AK, Heba E, Loomba R, Schwimmer J, Middleton MS, Sirlin CB. Intra- and inter-examination repeatability of magnetic resonance spectroscopy, magnitude-based MRI, and complex-based MRI for estimation of hepatic proton density fat fraction in overweight and obese children and adults. Abdom Imaging. 2015 Oct;40(8):3070-7. doi: 10.1007/s00261-015-0542-5. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary MRI PDFF correlation/agreement to UDFF Liver fat % derived using MR PDFF will be compared to UDFF Single time point-30 minute MRI/30 minute Ultrasound
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