Clinical trial NCT04523584: Ultrasound Quantification of Liver Fat
Official title: Ultrasound Quantification of Liver Fat
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2020-08-21
Enrollment: 192
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: MRI PDFF correlation/agreement to UDFF
timeFrame: Single time point-30 minute MRI/30 minute Ultrasound
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
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.
citation: 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.
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.
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.
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. doi: 10.1148/radiol.2016152797. Epub 2016 May 26.
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.
citation: Dillman JR, Thapaliya S, Tkach JA, Trout AT. Quantification of Hepatic Steatosis by Ultrasound: Prospective Comparison With MRI Proton Density Fat Fraction as Reference Standard. AJR Am J Roentgenol. 2022 Nov;219(5):784-791. doi: 10.2214/AJR.22.27878. Epub 2022 Jun 8.