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Clinical Trial
. 2023 Oct 1;78(4):1200-1208.
doi: 10.1097/HEP.0000000000000417. Epub 2023 May 1.

Head-to-head comparison of magnetic resonance elastography-based liver stiffness, fat fraction, and T1 relaxation time in identifying at-risk NASH

Jiahui Li  1 , Xin Lu  1   2 , Zheng Zhu  1 , Kyle J Kalutkiewicz  1 , Taofic Mounajjed  3 , Terry M Therneau  4 , Sudhakar K Venkatesh  1 , Yi Sui  1 , Kevin J Glaser  1 , Safa Hoodeshenas  1 , Armando Manduca  1 , Vijay H Shah  5 , Richard L Ehman  1 , Alina M Allen  5 , Meng Yin  1
Affiliations
Clinical Trial

Head-to-head comparison of magnetic resonance elastography-based liver stiffness, fat fraction, and T1 relaxation time in identifying at-risk NASH

Jiahui Li et al. Hepatology. .

Abstract

Background and aims: The presence of at-risk NASH is associated with an increased risk of cirrhosis and complications. Therefore, noninvasive identification of at-risk NASH with an accurate biomarker is a critical need for pharmacologic therapy. We aim to explore the performance of several magnetic resonance (MR)-based imaging parameters in diagnosing at-risk NASH.

Approach and results: This prospective clinical trial (NCT02565446) includes 104 paired MR examinations and liver biopsies performed in patients with suspected or diagnosed NAFLD. Magnetic resonance elastography-assessed liver stiffness (LS), 6-point Dixon-derived proton density fat fraction (PDFF), and single-point saturation-recovery acquisition-calculated T1 relaxation time were explored. Among all predictors, LS showed the significantly highest accuracy in diagnosing at-risk NASH [AUC LS : 0.89 (0.82, 0.95), AUC PDFF : 0.70 (0.58, 0.81), AUC T1 : 0.72 (0.61, 0.82), z -score test z >1.96 for LS vs any of others]. The optimal cutoff value of LS to identify at-risk NASH patients was 3.3 kPa (sensitivity: 79%, specificity: 82%, negative predictive value: 91%), whereas the optimal cutoff value of T1 was 850 ms (sensitivity: 75%, specificity: 63%, and negative predictive value: 87%). PDFF had the highest performance in diagnosing NASH with any fibrosis stage [AUC PDFF : 0.82 (0.72, 0.91), AUC LS : 0.73 (0.63, 0.84), AUC T1 : 0.72 (0.61, 0.83), |z| <1.96 for all].

Conclusion: Magnetic resonance elastography-assessed LS alone outperformed PDFF, and T1 in identifying patients with at-risk NASH for therapeutic trials.

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Conflict of interest statement

Study design, database creation, and data acquisition: Jiahui Li, Xin Lu, and Zheng Zhu. Manuscript preparation: Jiahui Li, Xin Lu, Alina M. Allen, and Meng Yin. Statistical analysis: Jiahui Li and Kyle J. Kalutkiewicz. Statistical review: Terry M. Therneau. Critical revision of the manuscript: Jiahui Li, Terry M. Therneau, Richard L. Ehman, Alina M. Allen, and Meng Yin. Imaging review: Safa Hoodeshenas, Sudhakar K. Venkatesh, and Taofic Mounajjed. Technical/material support: Yi Sui, Kevin J. Glaser, Armando Manduca, Sudhakar K. Venkatesh, Vijay H. Shah, Richard L. Ehman, Alina M. Allen, and Meng Yin. Study concept and design, database creation, funding obtainment, and study supervision: Vijay H. Shah, Richard L. Ehman, Alina M. Allen, and Meng Yin.

Kyle J. Kalutkiewicz is employed by and consults for Resoundant, Inc. Kevin J. Glaser owns stock in and intellectual property rights with Resoundant, Inc. Armando Manduca owns stock in Resoundant, Inc. Richard L. Ehman owns stock in, owns intellectual property rights with, and received grants from Resoundant, Inc. Alina M. Allen consults for, advises, and received grants from Novo Nordisk. She received grants from Pfizer and Target Pharma. Meng Yin owns stock in and intellectual property rights with Resoundant, Inc. The remaining authors have no conflicts to report.

Figures

None
Graphical abstract
FIGURE 1
FIGURE 1
Example images. The first row represents images from a patient with non-NASH (female, 45 y, BMI = 30.2 kg/m2): PDFF = 2.1%, LS = 1.69 kPa, T1 = 794 ms. The second row represents images from a patient with NASH (female, 48 y, BMI = 32.8 kg/m2): PDFF = 20.4%, LS = 2.43 kPa, T1 = 1004 ms. The third row represents images from a patient with at-risk NASH (male, 60 y, BMI = 27.5 kg/m2): PDFF = 10.6%, LS = 3.94 kPa, T1 = 858 ms. The white dotted line illustrates the contour of the liver not the ROI for measurements. Abbreviations: BMI, body mass index; LS, liver stiffness; ROI, regions of interest; PDFF, proton density fat fraction.
FIGURE 2
FIGURE 2
Scatter plots of PDFF and T1 for differentiating steatosis grades and NASH. The black line indicates the median value. *p < 0.05; **p < 0.01; ***p < 0.0001. Abbreviation: PDFF, proton density fat fraction.
FIGURE 3
FIGURE 3
Scatter plots of LS and T1 for differentiating clinically significant fibrosis (≥stage 2) and at-risk NASH. The black line indicates the median value. *p < 0.05; **p < 0.01; ***p < 0.0001. Abbreviation: LS, liver stiffness.
FIGURE 4
FIGURE 4
Correlations between PDFF and T1/LS. **p < 0.01. Abbreviations: LS, liver stiffness; PDFF, proton density fat fraction.
FIGURE 5
FIGURE 5
Summary of AUC for nominal logistic models for distinguishing NASH and at-risk NASH. *z > 1.96 when compared with LS in diagnosing at-risk NASH. Abbreviations: LS, liver stiffness; PDFF, proton density fat fraction.
See this image and copyright information in PMC

Comment in

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