Methods and Validation of Velacur Determined Fat Fraction in patients with MASLD

Area of Science:

• Medical Imaging
• Hepatology
• Quantitative Ultrasound

Background:

• Increasing global prevalence of steatotic liver diseases necessitates accurate and accessible fat content estimation.
• Quantitative ultrasound parameters (attenuation, backscatter) show potential for estimating liver fat.
• MRI proton density fat fraction (PDFF) is the current reference standard for liver fat quantification.

Purpose of the Study:

• To describe the parameter fitting and validation of Velacur Determined Fat Fraction (VDFF).
• To assess VDFF's accuracy in estimating liver fat compared to MRI-PDFF.
• To evaluate VDFF as a potential diagnostic tool for hepatic steatosis.

Main Methods:

• Recruitment of patients from US and Canadian sites with contemporaneous Velacur and MRI-PDFF scans.
• Quantitative ultrasound parameter fitting using linear regression on a random sub-sample.
• Validation of VDFF using a separate patient cohort, measuring AUROC and correlation with MRI-PDFF.

Main Results:

• VDFF achieved an AUROC of 0.97 (parameter fitting) and 0.99 (validation) for detecting >5% liver fat by MRI-PDFF.
• High correlation observed between MRI-PDFF and VDFF: r=0.84 (fitting) and r=0.90 (validation).
• Quantitative ultrasound parameters demonstrated strong performance in VDFF estimation.

Conclusions:

• Velacur Determined Fat Fraction (VDFF) provides an accurate and accessible method for estimating liver steatosis.
• VDFF shows significant potential as an alternative to liver biopsy or MRI-PDFF for diagnosing hepatic steatosis.
• This quantitative ultrasound technique addresses the need for reliable non-invasive liver fat assessment.