• Hye Jin Kim, Hyo Jung Cho, Bohyun Kim, Myung-Won You, Jei Hee Lee, Jimi Huh, and Jai Keun Kim.
• Department of Radiology, Ajou University School of Medicine, Ajou University Hospital, Suwon, South Korea.
• J Magn Reson Imaging. 2019 Jul 1; 50 (1): 305-314.

BackgroundComplex-based chemical shift imaging-based magnetic resonance imaging (CSE-MRI) is emerging as a preferred method for noninvasively quantifying proton density fat fraction (PDFF), a promising quantitative imaging biomarker (QIB) for longitudinal hepatic steatosis measurement.PurposeTo determine linearity, bias, repeatability, and reproducibility of the PDFF measurement using CSE-MRI (CSE-PDFF) across scan intervals, MR field strengths, and readers in phantom and nonalcoholic fatty liver disease (NAFLD) patients.Study TypeInstitutional Review Board (IRB)-approved prospective.SubjectsFat-water phantom and 20 adult patients.Field Strength/Sequence1.5 T and 3.0 T MR systems and a commercially available CSE-MRI sequence (IDEAL-IQ).AssessmentTwo independent readers measured CSE-PDFF of fat-water phantom and NAFLD patients across two field strengths and scan intervals (same-day and 2-week) each and in a combination of both. MR spectroscopy-based PDFF (MRS-PDFF) was used as the reference standard for phantom PDFF.Statistical TestsLinearity and bias of measurement were evaluated by linear regression analysis and Bland-Altman plots, respectively. Repeatability and reproducibility were assessed by coefficient of variance and repeatability / reproducibility coefficients (RC). The intraclass correlation coefficient was used to validate intra- and interobserver agreements.ResultsCSE-PDFF showed high linearity and small bias (-0.6-0.4 PDFF%) with 95% limits of agreement within ±2.9 PDFF% across field strengths, 2-week interscan period, and readers in the clinical scans. CSE-PDFF was highly repeatable and reproducible both in phantom and clinical scans, with the largest observed RC across field strengths and 2-week interscan period being 3 PDFF%.Data ConclusionCSE-PDFF is a robust QIB with high linearity, small bias, and excellent repeatability/reproducibility. A change of more than 3 PDFF% across field strengths within 2 weeks of scan interval likely reflects a true change, which is well within the clinically acceptable range.Level Of Evidence3 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2019;50:305-314.© 2018 International Society for Magnetic Resonance in Medicine.

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