Non-Alcoholic Fatty Liver DiseaseNCT04523584
Ultrasound Quantification of Liver Fat
An observational study of Non-Alcoholic Fatty Liver Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The investigators plan a prospective study designed to evaluate the accuracy of a new ultrasound method for quantification of liver fat content. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Magnetic Resonance Imaging (MRI) and Ultrasound Imaging
- Type of treatment
- Medical device
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2016to 22 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The investigators plan a prospective study designed to evaluate the accuracy of a new ultrasound method for quantification of liver fat content.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Magnetic Resonance Imaging (MRI), Ultrasound Imaging
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Device
Participants will undergo MR imaging of the liver. Liver PDFF will be measured.
Ultrasound ImagingDevice
Participants will undergo ultrasound imaging of the liver. UDFF and shear wave speed (US-SWS) will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Hepatic Steatosis | <5% liver fat fraction by MRI PDFF Receives: Device: Magnetic Resonance Imaging (MRI); Device: Ultrasound Imaging | |
| No Hepatic Steatosis | >5% liver fat fraction by MRI PDFF Receives: Device: Magnetic Resonance Imaging (MRI); Device: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI PDFF correlation/agreement to UDFF
Liver fat % derived using MR PDFF will be compared to UDFF
Measured: Single time point-30 minute MRI/30 minute Ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start8 Nov 2016
- Primary completion14 Dec 2020
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523584
- Sponsor's protocol ID
- CIN_US Liver Fat
- Status last verified
- Jun 2022
- First submitted
- 14 Aug 2020
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23271404Fierbinteanu 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.
PubMed 23932277Kinner 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.
PubMed 26848588Middleton 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.
PubMed 29028128Trout 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.
PubMed 27228332Tyagi 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.
PubMed 26350282Dillman 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.
PubMed 35674351
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Quantification of Liver Fat
- ClinicalTrials.gov ID
- NCT04523584
- Acronym / sponsor ID
- CIN_US Liver Fat
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatic Steatosis | – | Device: Magnetic Resonance Imaging (MRI), Device: Ultrasound Imaging<5% liver fat fraction by MRI PDFF |
| No Hepatic Steatosis | – | Device: Magnetic Resonance Imaging (MRI), Device: Ultrasound Imaging>5% liver fat fraction by MRI PDFF |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Participants will undergo MR imaging of the liver. Liver PDFF will be measured. | Device | Hepatic Steatosis, No Hepatic Steatosis |
| Ultrasound ImagingParticipants will undergo ultrasound imaging of the liver. UDFF and shear wave speed (US-SWS) will be measured. | Device | Hepatic Steatosis, No Hepatic Steatosis |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Background: PubMed 23271404Hanquinet 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.
- Background: PubMed 23932277Fierbinteanu 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.
- Background: PubMed 26848588Kinner 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.
- Background: PubMed 29028128Middleton 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.
- Background: PubMed 27228332Trout 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.
- Background: PubMed 26350282Tyagi 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.
- Derived from this study: PubMed 35674351Dillman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI PDFF correlation/agreement to UDFF (time frame: Single time point-30 minute MRI/30 minute Ultrasound). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04523584, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.