Evidence map›Paper›PMID 31965579›Full record

Trial reportHepatology (Baltimore, Md.)2020

Multicenter Validation of Association Between Decline in MRI-PDFF and Histologic Response in NASH.

Rohit Loomba, Brent A Neuschwander-Tetri, Arun Sanyal, Naga Chalasani, Anna Mae Diehl, Norah Terrault, Kris Kowdley, Srinivasan Dasarathy, David Kleiner, Cynthia Behling and 6 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04626492 (Clinical Study on the Value of Quantitative MRI Imaging in Diffuse Liver Diseases), which is not on this map. Cited by 79 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 7 pooled it
11.9field-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.

NCT04626492 unknown statusnot on this map

Clinical Study on the Value of Quantitative MRI Imaging in Diffuse Liver Diseases

Typeobservational_patient_registrySponsorFifth Affiliated Hospital, Sun Yat-Sen UniversityRan2020 to 2022Enrolled150ConditionsFibrosis and Cirrhosis of LiverArmsQuantitative MRI imaging
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 7 syntheses or guidelines pooled it, 134 citations in OpenAlex.

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  5. 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
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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 11 institutions in 1 country.

Rohit LoombaNAFLD Research Center, Division of Gastroenterology and Hepatology Department of Medicine, University of California San Diego, La Jolla, CA.ORCID 0000-0002-4845-9991
Brent A Neuschwander-TetriDivision of Gastroenterology and Hepatology, Department of Medicine, Saint Louis University, St. Louis, MO.
Arun SanyalDivision of Gastroenterology, Hepatology and Nutrition, Department of Medicine, Virginia Commonwealth University, Richmond, VA.
Naga ChalasaniDivision of Gastroenterology, Department of Medicine, Indiana University, Indianapolis, IN.
Anna Mae DiehlDivision of Gastroenterology and Hepatology, Department of Medicine, Duke University, Durham, NC.
Norah TerraultDivision of Gastroenterology, Department of Medicine, University of California San Francisco, San Francisco, CA.ORCID 0000-0003-4143-1950
Kris KowdleyLiver Center, Department of Medicine, Swedish Medical Center, Seattle, WA.
Srinivasan DasarathyDivision of Gastroenterology, Department of Medicine, Cleveland Clinic, Cleveland, OH.
David KleinerLaboratory of Pathology, The National Cancer Institute, Bethesda, MD.
Cynthia BehlingNAFLD Research Center, Division of Gastroenterology and Hepatology Department of Medicine, University of California San Diego, La Jolla, CA.
Joel LavineDivision of Gastroenterology, Department of Pediatrics, Columbia University, New York, NY.
Mark Van NattaDepartment of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.
Michael MiddletonNAFLD Research Center, Division of Gastroenterology and Hepatology Department of Medicine, University of California San Diego, La Jolla, CA.
James TonasciaDepartment of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.
Claude SirlinNAFLD Research Center, Division of Gastroenterology and Hepatology Department of Medicine, University of California San Diego, La Jolla, CA.
NASH Clinical Research Network
University of California San Diego · USJohns Hopkins University · USCleveland Clinic · USColumbia University Irving Medical Center · USDuke University · USIndiana University Health · USNational Cancer Institute · USSaint Louis University · USSwedish Medical Center · USUniversity of California, San Francisco · USVirginia Commonwealth University · US

Funding

WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
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
QAQC Johns Hopkins Institute for Clinical and Translational ResearchUL1TR003098 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2019 to 2023
$57.7M
Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
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 Collaborative of ClevelandUL1TR002548 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI MCCOMSEY, GRACE A · 2018 to 2022
$35.5M
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
Continuation of the Non-Alcoholic Steatohepatitis Clinical Research Network (NASHU01DK061730 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI TONASCIA, JAMES A · 2002 to 2018
$23.2M
Intramural NIH HHSNCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1TR000004NCATS NIH HHS UL1 TR000006NCATS NIH HHS UL1TR000006NCATS NIH HHS UL1 TR000040NCATS NIH HHS UL1TR000040NCATS NIH HHS UL1 TR000058NCATS NIH HHS UL1TR000058NCATS NIH HHS UL1 TR000077NCATS NIH HHS UL1TR000077NCATS NIH HHS UL1 TR000100NCATS NIH HHS UL1TR000100NCATS NIH HHS UL1 TR000150NCATS NIH HHS UL1TR000150NCATS NIH HHS UL1 TR000423NCATS NIH HHS UL1TR000423NCATS NIH HHS UL1 TR000424NCATS NIH HHS UL1TR000424NCATS NIH HHS UL1 TR000436NCATS NIH HHS UL1TR000436NCATS NIH HHS UL1 TR000439NCATS NIH HHS UL1TR000439NCATS NIH HHS UL1 TR000448NCATS NIH HHS UL1TR000448NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1TR000454NCATS NIH HHS UL1 TR001442NCATS NIH HHS UL1 TR002345NCATS NIH HHS UL1 TR002548NCATS NIH HHS UL1 TR002649NCATS NIH HHS UL1 TR003098NIDDK NIH HHS P30 DK120515NIDDK NIH HHS P30DK120515NIDDK NIH HHS R01 DK106419NIDDK NIH HHS R01DK106419NIDDK NIH HHS U01 DK061713NIDDK NIH HHS U01DK061713NIDDK NIH HHS U01 DK061718NIDDK NIH HHS U01DK061718NIDDK NIH HHS U01 DK061728NIDDK NIH HHS U01DK061728NIDDK NIH HHS U01 DK061730NIDDK NIH HHS U01DK061730NIDDK NIH HHS U01 DK061731NIDDK NIH HHS U01DK061731NIDDK NIH HHS U01 DK061732NIDDK NIH HHS U01DK061732NIDDK NIH HHS U01 DK061734NIDDK NIH HHS U01DK061734NIDDK NIH HHS U01 DK061737NIDDK NIH HHS U01DK061737NIDDK NIH HHS U01 DK061738NIDDK NIH HHS U01DK061738NIDDK NIH HHS U24 DK061730
6 · The paper itself

Abstract

BACKGROUND AND

aimsEmerging data from a single-center study suggests that a 30% relative reduction in liver fat content as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) from baseline may be associated with histologic improvement in nonalcoholic steatohepatitis (NASH). There are limited multicenter data comparing an active drug versus placebo on the association between the quantity of liver fat reduction assessed by MRI-PDFF and histologic response in NASH. This study aims to examine the association between 30% relative reduction in MRI-PDFF and histologic response in obeticholic acid (OCA) versus placebo-treated patients in the FLINT (farnesoid X receptor ligand obeticholic acid in NASH trial). APPROACH AND

resultsThis is a secondary analysis of the FLINT trial including 78 patients with MRI-PDFF measured before and after treatment along with paired liver histology assessment. Histologic response was defined as a 2-point improvement in nonalcoholic fatty liver disease activity score without worsening of fibrosis. OCA (25 mg orally once daily) was better than placebo in improving MRI-PDFF by an absolute difference of -3.4% (95% confidence interval [CI], -6.5 to -0.2%, P value = 0.04) and relative difference of -17% (95% CI, -34 to 0%, P value = 0.05). The optimal cutoff point for relative decline in MRI-PDFF for histologic response was 30% (using Youden's index). The rate of histologic response in those who achieved less than 30% decline in MRI-PDFF versus those who achieved a 30% or greater decline in MRI-PDFF (MRI-PDFF responders) relative to baseline was 19% versus 50%, respectively. Compared with MRI-PDFF nonresponders, MRI-PDFF responders demonstrated both a statistically and clinically significant higher odds 4.86 (95% CI, 1.4-12.8, P value < 0.009) of histologic response, including significant improvements in both steatosis and ballooning.

conclusionOCA was better than placebo in reducing liver fat. This multicenter trial provides data regarding the association between 30% decline in MRI-PDFF relative to baseline and histologic response in NASH.

Indexed as

Adipose TissueAdultAgedChenodeoxycholic AcidDouble-Blind MethodFemaleHumansLiverMagnetic Resonance ImagingMaleMiddle AgedNon-alcoholic Fatty Liver DiseaseProtonsWeight LossChenodeoxycholic Acidobeticholic acidProtons

Identifiers

PMID31965579
PMCPMC8055244
OpenAlexW3001786135

What Socratic holds

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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 Socratic graph.