Repeatability of MRI Biomarkers in Nonalcoholic Fatty Liver Disease: The NIMBLE Consortium.


Journal

Radiology
ISSN: 1527-1315
Titre abrégé: Radiology
Pays: United States
ID NLM: 0401260

Informations de publication

Date de publication:
10 2023
Historique:
pmc-release: 01 10 2024
medline: 1 11 2023
pubmed: 10 10 2023
entrez: 10 10 2023
Statut: ppublish

Résumé

Background There is a need for reliable noninvasive methods for diagnosing and monitoring nonalcoholic fatty liver disease (NAFLD). Thus, the multidisciplinary Non-invasive Biomarkers of Metabolic Liver disease (NIMBLE) consortium was formed to identify and advance the regulatory qualification of NAFLD imaging biomarkers. Purpose To determine the different-day same-scanner repeatability coefficient of liver MRI biomarkers in patients with NAFLD at risk for steatohepatitis. Materials and Methods NIMBLE 1.2 is a prospective, observational, single-center short-term cross-sectional study (October 2021 to June 2022) in adults with NAFLD across a spectrum of low, intermediate, and high likelihood of advanced fibrosis as determined according to the fibrosis based on four factors (FIB-4) index. Participants underwent up to seven MRI examinations across two visits less than or equal to 7 days apart. Standardized imaging protocols were implemented with six MRI scanners from three vendors at both 1.5 T and 3 T, with central analysis of the data performed by an independent reading center (University of California, San Diego). Trained analysts, who were blinded to clinical data, measured the MRI proton density fat fraction (PDFF), liver stiffness at MR elastography (MRE), and visceral adipose tissue (VAT) for each participant. Point estimates and CIs were calculated using χ

Identifiants

pubmed: 37815451
doi: 10.1148/radiol.231092
pmc: PMC10625902
doi:

Substances chimiques

Biomarkers 0

Banques de données

ClinicalTrials.gov
['NCT05081427']

Types de publication

Journal Article Observational Study Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, P.H.S.

Langues

eng

Sous-ensembles de citation

IM

Pagination

e231092

Subventions

Organisme : NIBIB NIH HHS
ID : R01 EB001981
Pays : United States
Organisme : NIBIB NIH HHS
ID : R37 EB001981
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001442
Pays : United States

Commentaires et corrections

Type : CommentIn

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Auteurs

Kathryn J Fowler (KJ)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Sudhakar K Venkatesh (SK)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Nancy Obuchowski (N)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Michael S Middleton (MS)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Jun Chen (J)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Kay Pepin (K)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Jessica Magnuson (J)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Kathy J Brown (KJ)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Danielle Batakis (D)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Walter C Henderson (WC)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Sudha S Shankar (SS)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Tania N Kamphaus (TN)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Alex Pasek (A)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Roberto A Calle (RA)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Arun J Sanyal (AJ)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Rohit Loomba (R)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Richard Ehman (R)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Anthony E Samir (AE)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Claude B Sirlin (CB)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

Sarah P Sherlock (SP)

From the Liver Imaging Group (K.J.F., M.S.M., D.B., W.C.H., C.B.S.) and Department of Hepatology (R.L.), University of California-San Diego, 6206 Lakewood St, San Diego, CA 92122; Department of Radiology, Mayo Clinic, Rochester, Minn (S.K.V., J.C., K.P., J.M., K.J.B., R.E.); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio (N.O.); Pfizer Research and Development, Pfizer, Inc, Sacramento, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (T.N.K., A.P.); Regeneron Pharmaceuticals, Inc, Tarrytown, NY (R.A.C.); Department of Gastroenterology, Virginia Commonwealth University, Richmond, Va (A.J.S.); Department of Radiology, Massachusetts General Hospital, Boston, Mass (A.E.S.); and Department of Imaging Alliances, Pfizer, Inc, New York, NY (S.P.S.).

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