Quantification of Hepatic Steatosis by Ultrasound: Prospective Comparison With MRI Proton Density Fat Fraction as Reference Standard.

Abstract

<b>BACKGROUND.</b> Multiple ultrasound platforms now provide quantitative measures of hepatic steatosis. One such measure is the ultrasound-derived fat fraction (UDFF), which combines attenuation and backscatter quantification. <b>OBJECTIVE.</b> The purpose of this study was to characterize agreement between UDFF and MRI proton-density fat fraction (PDFF) measurements. <b>METHODS.</b> This prospective cross-sectional study enrolled 56 overweight and obese adolescents and adults (age ≥ 16 years) who underwent investigational ultrasound (deep abdominal transducer) and MRI examinations of the liver during a single visit from August 2020 to October 2020. Ultrasound examinations included three UDFF acquisitions of five measurements each (15 measurements total), and an overall median of medians was computed (UDFF_overall). MRI examinations included three PDFF acquisitions with calculation of an overall median PDFF. Spearman rank-order correlation was computed between UDFF and MRI PDFF measurements. Intraclass correlation coefficients and Bland-Altman difference plots were used to assess agreement. ROC curves were used to assess diagnostic performance of UDFF for detecting MRI PDFF of 5.5% or more. <b>RESULTS.</b> Median participant age was 32.5 years (IQR, 24.0-39.0 years); 40 participants were female, and 16 were male. A total of 34 (60.7%) participants had an MRI PDFF of 5.5% or more. UDFF_overall was 10.5% (IQR, 5.0-20.0%); median MRI PDFF was 6.1% (IQR, 3.4-13.7%). UDFF_overall was positively associated with MRI PDFF (ρ, 0.82; <i>p</i> < .001; intraclass correlation coefficient, 0.84 [95% CI, 0.59-0.93]). Mean bias between UDFF and PDFF was 4.0% (95% limits of agreement, -7.9% to 15.9%), with similar bias if summarizing UDFF by the first five measurements (4.4%), first three measurements (4.4%), or first measurement (4.6%). UDFF_overall AUC was 0.90 (95% CI, 0.79-0.96) for MRI PDFF of 5.5% or more; AUC was not significantly different when it was based on the number of UDFF measurements (<i>p</i> = .11-.97 for all pairwise AUC comparisons). UDFF_overall cutoff of more than 5% had sensitivity of 94.1% and specificity of 63.6% for diagnosing MRI PDFF of 5.5% or more. <b>CONCLUSION.</b> Measurements of hepatic steatosis using UDFF show strong agreement with measurements by MRI PDFF. A UDFF_overall cutoff of more than 5% provides high AUC and sensitivity, albeit low specificity, for detection of MRI PDFF of 5.5% or more. <b>CLINICAL IMPACT.</b> UDFF may have a clinical role in detection of hepatic steatosis. A reduced number of individual measurements is likely sufficient for determining an overall UDFF value. <b>TRIAL REGISTRATION.</b> ClinicalTrials.gov: NCT04523584.