Evidence map›Paper›PMID 29028128›Full record

Trial reportHepatology (Baltimore, Md.)2018

Diagnostic accuracy of magnetic resonance imaging hepatic proton density fat fraction in pediatric nonalcoholic fatty liver disease.

Michael S Middleton, Mark L Van Natta, Elhamy R Heba, Adina Alazraki, Andrew T Trout, Prakash Masand, Elizabeth M Brunt, David E Kleiner, Edward Doo, James Tonascia and 6 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04523584 (Ultrasound Quantification of Liver Fat), which is not on this map. Cited by 79 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 11 pooled it
10.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04523584 completednot on this map

Ultrasound Quantification of Liver Fat

TypeobservationalSponsorChildren's Hospital Medical Center, CincinnatiRan2016 to 2021Enrolled192ConditionsNon-Alcoholic Fatty Liver DiseaseArmsMagnetic Resonance Imaging (MRI), Ultrasound Imaging
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 11 syntheses or guidelines pooled it, 154 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Guideline
  8. Pooled it
  9. Change in MRI-PDFF and Histologic Response in Patients With Nonalcoholic Steatohepatitis: A Systematic Review and Meta-Analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2021
    Pooled it
  10. Pooled it
  11. Pooled it
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article

19 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 1 country.

Michael S MiddletonLiver Imaging Group, Department of Radiology, UCSD School of Medicine, San Diego, CA.
Mark L Van NattaJohns Hopkins Bloomberg School of Public Health, Baltimore, MD.
Elhamy R HebaLiver Imaging Group, Department of Radiology, UCSD School of Medicine, San Diego, CA.
Adina AlazrakiEmory University School of Medicine, Department of Radiology and Imaging Sciences, Atlanta, GA.
Andrew T TroutCincinnati Children's Hospital, Department of Radiology, Cincinnati, OH.ORCID 0000-0003-1431-4054
Prakash MasandTexas Children's Hospital, Houston, TX.
Elizabeth M BruntEmeritus, Washington University School of Medicine, St. Louis, MO.
David E KleinerLaboratory of Pathology, National Cancer Institute, Bethesda, MD.
Edward DooLiver Diseases Section, Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.
James TonasciaJohns Hopkins Bloomberg School of Public Health, Baltimore, MD.
Joel E LavineDivision of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Columbia University Medical Center, New York, NY.
Wei ShenDivision of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Columbia University Medical Center, New York, NY.
Gavin HamiltonLiver Imaging Group, Department of Radiology, UCSD School of Medicine, San Diego, CA.
Jeffrey B SchwimmerDivision of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, California; and Department of Gastroenterology, Rady Children's Hospital, San Diego, CA.
Claude B SirlinLiver Imaging Group, Department of Radiology, UCSD School of Medicine, San Diego, CA.
NASH Clinical Research Network
University of California San Diego · USColumbia University Irving Medical Center · USJohns Hopkins University · USCincinnati Children's Hospital Medical Center · USEmory University · USNational Cancer Institute · USNational Institute of Diabetes and Digestive and Kidney Diseases · USTexas Children's Hospital · USWashington University in St. Louis · US

Funding

Transform Dissemination and Implementation Science in CTSA ProgramsUL1TR002319 · NCATS · UNIVERSITY OF WASHINGTON · PI John K. Amory · 2017 to 2026
$100.0M
WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE)UL1TR002378 · NCATS · EMORY UNIVERSITY · PI Andres J Garcia, Elizabeth O. Ofili · 2017 to 2026
$92.1M
UC San Diego Clinical and Translational Research InstituteUL1TR001442 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S, HOGARTH, MICHAEL · 2015 to 2024
$88.3M
Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
Northwestern University Clinical and Translational Science Institute (NUCATS)UL1TR001422 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI D'AQUILA, RICHARD · 2015 to 2023
$56.8M
Institute of Translational Health SciencesUL1TR000423 · NCATS · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2012 to 2016
$49.4M
Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
Pediatric Trials in Non-Alcoholic Steatohepatitis (NASH)U01DK061734 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI ROHIT LOOMBA · 2002 to 2026
$24.4M
Indiana Clinical and Translational Sciences InstituteUL1TR001108 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI DENNE, SCOTT C., SHEKHAR, ANANTHA · 2013 to 2017
$23.3M
Intramural NIH HHS Z99 CA999999NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1 TR000006NCATS NIH HHS UL1 TR000040NCATS NIH HHS UL1 TR000077NCATS NIH HHS UL1 TR000100NCATS NIH HHS UL1 TR000150NCATS NIH HHS UL1 TR000423NCATS NIH HHS UL1 TR000424NCATS NIH HHS UL1 TR000448NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1 TR001108NCATS NIH HHS UL1 TR001422NCATS NIH HHS UL1 TR001442NCATS NIH HHS UL1 TR002319NCATS NIH HHS UL1 TR002345NCATS NIH HHS UL1 TR002378NIDDK NIH HHS U01 DK061713NIDDK NIH HHS U01 DK061718NIDDK NIH HHS U01 DK061728NIDDK NIH HHS U01 DK061730NIDDK NIH HHS U01 DK061731NIDDK NIH HHS U01 DK061732NIDDK NIH HHS U01 DK061734NIDDK NIH HHS U01 DK061737NIDDK NIH HHS U01 DK061738
6 · The paper itself

Abstract

We assessed the performance of magnetic resonance imaging (MRI) proton density fat fraction (PDFF) in children to stratify hepatic steatosis grade before and after treatment in the Cysteamine Bitartrate Delayed-Release for the Treatment of Nonalcoholic Fatty Liver Disease in Children (CyNCh) trial, using centrally scored histology as reference. Participants had multiecho 1.5 Tesla (T) or 3T MRI on scanners from three manufacturers. Of 169 enrolled children, 110 (65%) and 83 (49%) had MRI and liver biopsy at baseline and at end of treatment (EOT; 52 weeks), respectively. At baseline, 17% (19 of 110), 28% (31 of 110), and 55% (60 of 110) of liver biopsies showed grades 1, 2, and 3 histological steatosis; corresponding PDFF (mean ± SD) values were 10.9 ± 4.1%, 18.4 ± 6.2%, and 25.7 ± 9.7%, respectively. PDFF classified grade 1 versus 2-3 and 1-2 versus 3 steatosis with areas under receiving operator characteristic curves (AUROCs) of 0.87 (95% confidence interval [CI], 0.80, 0.94) and 0.79 (0.70, 0.87), respectively. PDFF cutoffs at 90% specificity were 17.5% for grades 2-3 steatosis and 23.3% for grade 3 steatosis. At EOT, 47% (39 of 83), 41% (34 of 83), and 12% (10 of 83) of biopsies showed improved, unchanged, and worsened steatosis grade, respectively, with corresponding PDFF (mean ± SD) changes of -7.8 ± 6.3%, -1.2 ± 7.8%, and 4.9 ± 5.0%, respectively. PDFF change classified steatosis grade improvement and worsening with AUROCs (95% CIs) of 0.76 (0.66, 0.87) and 0.83 (0.73, 0.92), respectively. PDFF change cut-off values at 90% specificity were -11.0% and +5.5% for improvement and worsening.

conclusionMRI-estimated PDFF has high diagnostic accuracy to both classify and predict histological steatosis grade and change in histological steatosis grade in children with NAFLD. (Hepatology 2018;67:858-872).

Indexed as

AdolescentChildCross-Sectional StudiesCysteamineCystine Depleting AgentsDouble-Blind MethodFemaleHumansLiverMagnetic Resonance ImagingMaleNon-alcoholic Fatty Liver DiseaseProspective StudiesProtonsSensitivity and SpecificityCysteamineCystine Depleting AgentsProtons

Identifiers

PMID29028128
PMCPMC6211296
OpenAlexW2762936646

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.