Magnetic resonance imaging-proton density fat fraction: A potential surrogate endpoint for nonalcoholic steatohepatitis clinical trials

Ziming AN; Qin FENG

doi:10.3969/j.issn.1001-5256.2021.06.047

Volume 37 Issue 6

Jun. 2021

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Article Navigation > Journal of Clinical Hepatology > 2021 > 37(6): 1445-1448

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Magnetic resonance imaging-proton density fat fraction: A potential surrogate endpoint for nonalcoholic steatohepatitis clinical trials

DOI: 10.3969/j.issn.1001-5256.2021.06.047

Ziming AN¹,
Qin FENG^{1, 2, 3, 4
,
,}

1.
Institute of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
2.
Institute of Liver Diseases, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
3.
Shanghai Key Laboratory of Traditional Chinese Clinical Medicine, Shanghai 201203, China
4.
Key Laboratory of Liver and Kidney Diseases, Ministry of Education, Shanghai 201203, China

Received Date: 2020-11-02
Accepted Date: 2020-12-04
Published Date: 2021-06-20

Abstract

Abstract

Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) is an imaging method that uses magnetic resonance technology to perform objective, quantitative, and noninvasive assessment of fat in the whole liver. This article mainly analyzes the correlation between MRI-PDFF value and the "gold index" nonalcoholic steatohepatitis (NASH) liver histological evaluation and explores its advantages and disadvantages as a noninvasive evaluation index for NASH clinical trials. Current studies have shown that MRI-PDFF, as an emerging noninvasive technique, is suitable for quantifying liver fat content and evaluating the degree of hepatic steatosis, but it cannot replace liver biopsy as a tool for the diagnosis of NASH. Meanwhile, the relative reduction in MRI-PDFF after drug intervention is not only highly correlated with the improvement of fat deposition, but also correlated with the improvement of inflammation and ballooning degeneration, and MRI-PDFF can predict the overall improvement of liver histology to a certain extent. Therefore, MRI-PDFF is considered a potential surrogate endpoint for NASH clinical trials.
- Non-Alcoholic Steatohepatitis,
- Magnetic Resonance Imaging Proton Density Fat Fraction,
- Clinical Trail

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[1]	ZHOU F, ZHOU J, WANG W, et al. Unexpected rapid increase in the burden of NAFLD in China from 2008 to 2018: A systematic review and Meta-analysis[J]. Hepatology, 2019, 70(4): 1119-1133. DOI: 10.1002/hep.30702.
[2]	Committee of Hepatology, Chinese Research Hospital Association; Fatty Liver Expert Committee, Chinese Medical Doctor Association; National Workshop on Fatty Liver and Alcoholic Liver Disease, Chinese Society of Hepatology, et al. Expert recommendations on standardized diagnosis and treatment for fatty liver disease in China (2019 revised edition)[J]. J Clin Hepatol, 2019, 35(11): 2426-2430. DOI: 10.3969/j.issn.1001-5256.2019.11.007. 中国研究型医院学会肝病专业委员会, 中国医师协会脂肪性肝病专家委员会, 中华医学会肝病学分会脂肪肝与酒精性肝病学组, 等. 中国脂肪性肝病诊疗规范化的专家建议(2019年修订版)[J]. 临床肝胆病杂志, 2019, 35(11): 2426-2430. DOI: 10.3969/j.issn.1001-5256.2019.11.007.
[3]	MAO YM. Clinical trials of investigational new drugs for nonalcoholic steatohepatitis: challenges in design and practice[J]. J Clin Hepatol, 2017, 33(12): 2292-2295. DOI: 10.3969/j.issn.1001-5256.2017.12.007. 茅益民. 非酒精性脂肪性肝炎新药临床试验: 设计和实践中的挑战[J]. 临床肝胆病杂志, 2017, 33(12): 2292-2295. DOI: 10.3969/j.issn.1001-5256.2017.12.007.
[4]	CAUSSY C, REEDER SB, SIRLIN CB, et al. Noninvasive, quantitative assessment of liver fat by MRI-PDFF as an endpoint in NASH trials[J]. Hepatology, 2018, 68(2): 763-772. DOI: 10.1002/hep.29797.
[5]	MAMIDIPALLI A, FOWLER KJ, HAMILTON G, et al. Prospective comparison of longitudinal change in hepatic proton density fat fraction (PDFF) estimated by magnitude-based MRI (MRI-M) and complex-based MRI (MRI-C)[J]. Eur Radiol, 2020, 30(9): 5120-5129. DOI: 10.1007/s00330-020-06858-x.
[6]	REEDER SB, CRUITE I, HAMILTON G, et al. Quantitative assessment of liver fat with magnetic resonance imaging and spectroscopy[J]. J Magn Reson Imaging, 2011, 34(4): 729-749. DOI: 10.1002/jmri.22775.
[7]	JIANG LN, ZHAO JM. A clinical trial on the follow-up of nonalcoholic fatty liver disease: An evaluation of pathological endpoint[J]. J Clin Hepatol, 2018, 34(12): 2505-2508. DOI: 10.3969/j.issn.1001-5256.2018.12.004. 蒋丽娜, 赵景民. 跟踪非酒精性脂肪性肝病的临床试验-病理学终点评价[J]. 临床肝胆病杂志, 2018, 34(12): 2505-2508. DOI: 10.3969/j.issn.1001-5256.2018.12.004.
[8]	PIAZZOLLA VA, MANGIA A. Noninvasive diagnosis of NAFLD and NASH[J]. Cells, 2020, 9(4): 1005. DOI: 10.3390/cells9041005.
[9]	GU J, LIU S, DU S, et al. Diagnostic value of MRI-PDFF for hepatic steatosis in patients with non-alcoholic fatty liver disease: A meta-analysis[J]. Eur Radiol, 2019, 29(7): 3564-3573. DOI: 10.1007/s00330-019-06072-4.
[10]	QU Y, LI M, HAMILTON G, et al. Diagnostic accuracy of hepatic proton density fat fraction measured by magnetic resonance imaging for the evaluation of liver steatosis with histology as reference standard: A meta-analysis[J]. Eur Radiol, 2019, 29(10): 5180-5189. DOI: 10.1007/s00330-019-06071-5.
[11]	MIDDLETON MS, HEBA ER, HOOKER CA, et al. Agreement between magnetic resonance imaging proton density fat fraction measurements and pathologist-assigned steatosis grades of liver biopsies from adults with nonalcoholic steatohepatitis[J]. Gastroenterology, 2017, 153(3): 753-761. DOI: 10.1053/j.gastro.2017.06.005.
[12]	TANG A, TAN J, SUN M, et al. Nonalcoholic fatty liver disease: MR imaging of liver proton density fat fraction to assess hepatic steatosis[J]. Radiology, 2013, 267(2): 422-431. DOI: 10.1148/radiol.12120896.
[13]	PERMUTT Z, LE TA, PETERSON MR, et al. Correlation between liver histology and novel magnetic resonance imaging in adult patients with non-alcoholic fatty liver disease-MRI accurately quantifies hepatic steatosis in NAFLD[J]. Aliment Pharmacol Ther, 2012, 36(1): 22-29. DOI: 10.1111/j.1365-2036.2012.05121.x.
[14]	LE TA, CHEN J, CHANGCHIEN C, et al. Effect of colesevelam on liver fat quantified by magnetic resonance in nonalcoholic steatohepatitis: A randomized controlled trial[J]. Hepatology, 2012, 56(3): 922-932. DOI: 10.1002/hep.25731.
[15]	NOUREDDIN M, LAM J, PETERSON MR, et al. Utility of magnetic resonance imaging versus histology for quantifying changes in liver fat in nonalcoholic fatty liver disease trials[J]. Hepatology, 2013, 58(6): 1930-1940. DOI: 10.1002/hep.26455.
[16]	LOOMBA R, SIRLIN CB, ANG B, et al. Ezetimibe for the treatment of nonalcoholic steatohepatitis: Assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial)[J]. Hepatology, 2015, 61(4): 1239-1250. DOI: 10.1002/hep.27647.
[17]	JAYAKUMAR S, MIDDLETON MS, LAWITZ EJ, et al. Longitudinal correlations between MRE, MRI-PDFF, and liver histology in patients with non-alcoholic steatohepatitis: Analysis of data from a phase Ⅱ trial of selonsertib[J]. J Hepatol, 2019, 70(1): 133-141. DOI: 10.1016/j.jhep.2018.09.024.
[18]	WILDMAN-TOBRINER B, MIDDLETON MM, MOYLAN CA, et al. Association between magnetic resonance imaging-proton density fat fraction and liver histology features in patients with nonalcoholic fatty liver disease or nonalcoholic steatohepatitis[J]. Gastroenterology, 2018, 155(5): 1428-1435.e2. DOI: 10.1053/j.gastro.2018.07.018.
[19]	RINELLA ME, TACKE F, SANYAL AJ, et al. Report on the AASLD/EASL joint workshop on clinical trial endpoints in NAFLD[J]. Hepatology, 2019, 70(4): 1424-1436. DOI: 10.1002/hep.30782.
[20]	PATEL J, BETTENCOURT R, CUI J, et al. Association of noninvasive quantitative decline in liver fat content on MRI with histologic response in nonalcoholic steatohepatitis[J]. Therap Adv Gastroenterol, 2016, 9(5): 692-701. DOI: 10.1177/1756283X16656735.
[21]	LOOMBA R, NEUSCHWANDER-TETRI BA, SANYAL A, et al. Multicenter validation of association between decline in MRI-PDFF and histologic response in NASH[J]. Hepatology, 2020, 72(4): 1219-1229. DOI: 10.1002/hep.31121.
[22]	HARRISON SA, BASHIR MR, GUY CD, et al. Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: A multicentre, randomised, double-blind, placebo-controlled, phase 2 trial[J]. Lancet, 2019, 394(10213): 2012-2024. DOI: 10.1016/S0140-6736(19)32517-6.
[23]	HANNAH WN JR, TORRES DM, HARRISON SA. Nonalcoholic steatohepatitis and endpoints in clinical trials[J]. Gastroenterol Hepatol (NY), 2016, 12(12): 756-763.
[24]	BRIL F, BARB D, LOMONACO R, et al. Change in hepatic fat content measured by MRI does not predict treatment-induced histological improvement of steatohepatitis[J]. J Hepatol, 2020, 72(3): 401-410. DOI: 10.1016/j.jhep.2019.09.018.

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Magnetic resonance imaging-proton density fat fraction: A potential surrogate endpoint for nonalcoholic steatohepatitis clinical trials

DOI: 10.3969/j.issn.1001-5256.2021.06.047

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Magnetic resonance imaging-proton density fat fraction: A potential surrogate endpoint for nonalcoholic steatohepatitis clinical trials

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