Ultrasound Quantification of Liver Fat

NCT04523584 | Completed FDA Device

• 1 other identifier: CIN_US Liver Fat
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hepatic Steatosis

\<5% liver fat fraction by MRI PDFF

Device: Magnetic Resonance Imaging (MRI); Device: Ultrasound Imaging

No Hepatic Steatosis

\>5% liver fat fraction by MRI PDFF

Device: Magnetic Resonance Imaging (MRI); Device: Ultrasound Imaging

Interventions

Magnetic Resonance Imaging (MRI) DEVICE

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

Hepatic Steatosis; No Hepatic Steatosis

Ultrasound Imaging DEVICE

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

Hepatic Steatosis; No Hepatic Steatosis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Siemens Medical Solutions: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (7)

• 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.

  PMID: 23271404 BACKGROUND

• 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.

  PMID: 23932277 BACKGROUND

• 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.

  PMID: 26848588 BACKGROUND

• 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.

  PMID: 29028128 BACKGROUND

• 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.

  PMID: 27228332 BACKGROUND

• 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.

  PMID: 26350282 BACKGROUND

• 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.

  PMID: 35674351 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Magnetic Resonance Imaging; Ultrasonography

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 21, 2020
• Study Start: November 8, 2016
• Primary Completion: December 14, 2020
• Study Completion: July 22, 2021
• Last Updated: July 25, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)