Sheikh Muhammad Y, Hasan Nameer, Almozuaghi Marwan, Akhtar Nadeem M, Grewal Yugjeet, Schneider Caitlin
Fresno Clinical Research Center, Fresno, CA 93720, USA.
Sonic Incytes Medical Corp., Vancouver, BC V6J 1P2, Canada.
Diagnostics (Basel). 2025 Mar 4;15(5):615. doi: 10.3390/diagnostics15050615.
: Velacur is a novel, point-of-care ultrasound device developed to accurately diagnose patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH). The Velacur system non-invasively assesses liver stiffness, attenuation, and the Velacurdetermined fat fraction (VDFF). In this study, the performance of Velacur was measured against biopsy results in a cohort of MASLD and MASH patients. : This prospective study enrolled adult patients who were scheduled to undergo biopsy within 6 months of enrollment. The primary objective was to validate Velacur's findings against that of histological findings. The secondary objective was to compare Velacur results with those of FibroScan. : A total of 78 participants were enrolled, and 70 were included in the analysis. Patients had a mean age of 53.3 ± 13.1 years, with a mean BMI of 35.0 ± 6.24 kg/m. A total of 11, 19, 13, 25, and 2 were characterized as F0 to F4, respectively. The mean Velacur stiffness was 6.48 ± 1.4 kPa, and the mean VDFF was 14.4 ± 5.1%. In patients with significant fibrosis the Velacur AUC [95% CI] was 0.86 [0.76, 0.93] and 0.79 [0.66, 0.88] for patients with advanced fibrosis. For measurements of steatosis, 2, 24, 20, and 24 patients were found to have S0 to S3, respectively. To determine moderate steatosis (≥S2), the VDFF had an AUC of 0.846 [0.716, 0.920]. In the comparison population (n = 59), VDFF (0.85 [0.72, 0.94]) was significantly different than FibroScan CAP (0.50 [0.35, 0.66]) for the detection of moderate steatosis. : This study validates the use of Velacur as a non-invasive tool for assessment of steatosis and fibrosis, hallmarks of MASLD and MASH, when compared to histological evidence provided via hepatic biopsy. Further, Velacur outperformed FibroScan in the assessment of steatosis.
Velacur是一款新型的即时超声诊断设备，旨在准确诊断患有代谢功能障碍相关脂肪性肝病（MASLD）和代谢功能障碍相关脂肪性肝炎（MASH）的患者。Velacur系统可对肝脏硬度、衰减以及Velacur测定的脂肪分数（VDFF）进行无创评估。在本研究中，针对一组MASLD和MASH患者，对照活检结果对Velacur的性能进行了测定。
这项前瞻性研究纳入了计划在入组后6个月内接受活检的成年患者。主要目标是对照组织学检查结果验证Velacur的检查结果。次要目标是将Velacur的结果与FibroScan的结果进行比较。
总共招募了78名参与者，70名被纳入分析。患者的平均年龄为53.3±13.1岁，平均体重指数为35.0±6.24kg/m²。分别有11、19、13、25和2名患者的纤维化程度被判定为F0至F4。Velacur测定的平均肝脏硬度为6.48±1.4kPa，平均VDFF为14.4±5.1%。对于有显著纤维化的患者，Velacur的曲线下面积（AUC）[95%置信区间]为0.86[0.76,0.93]，对于有晚期纤维化的患者为0.79[0.66,0.88]。对于脂肪变性的测量，分别有2、24、20和24名患者的脂肪变性程度为S0至S3。为了确定中度脂肪变性（≥S2），VDFF的AUC为0.846[0.716,0.920]。在对照人群（n=59）中，对于中度脂肪变性的检测，VDFF（0.85[0.72,0.94]）与FibroScan受控衰减参数（CAP）（0.50[0.35,0.66]）有显著差异。
与通过肝活检提供的组织学证据相比，本研究验证了Velacur作为评估脂肪变性和纤维化（MASLD和MASH的特征）的无创工具的用途。此外，在脂肪变性评估方面，Velacur的表现优于FibroScan。
