ArticleRadiology advances2025
Liver shear wave elastography using a mechanical index exceeding regulatory limits is safe and effective.
Article in Radiology advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05792423 (Improving the Performance of Ultrasound Shear Wave Elastography), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Improving the Performance of Ultrasound Shear Wave Elastography (SWE) in Obese Fatty Liver Disease Patients by Developing a Conditionally Increased Output (CIO) Enhanced Ultrasound System
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Authors and funding
18 authors.
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Abstract
Background: Metabolic dysfunction-associated steatotic liver disease affects 1 in 3 people worldwide. Ultrasound shear wave elastography (SWE) in obese patients, the target population for testing, is hampered by beam attenuation, leading to unreliable liver fibrosis quantification. Purpose: We assess the safety and efficacy of increased push mechanical index (IPMI) above U.S. Food and Drug Administration limits to improve SWE. Materials and methods: This single-center prospective trial (July 2023-April 2024) (NCT05792423) enrolled healthy adults stratified by body mass index (BMI). Participants underwent conventional push pulse (mechanical index [MI] 1.4) and IPMI (MI 2.5) SWE (GE Healthcare LOGIQ E10) performed by 1 of 3 sonographers and serial liver function testing (LFT) before and up to 7 days after imaging. Liver injury was defined as increased serum alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) (non-inferiority margins: AST 7.5 U/L, ALT 12 U/L, ALP 17.5 U/L). Secondary endpoints included SWE variability and measurement number. Results: Twenty-two analyzable participants (mean age 39.6 ± 16.3 years; 15 women) had normal BMI (6), overweight (6), class 1 obesity (7), and class 2 obesity (3). Conventional shear wave speed was 1.34 ± 0.21 m/s, and IPMI yielded 1.36 ± 0.20 m/s (velocities ≤ 1.34 m/s indicate minimal or no fibrosis). The mean [95% CI] LFT change from baseline to day 1 was 1) AST: -0.86 [-2.34, 0.61], Conclusion: IPMI SWE in healthy volunteers did not cause injury and reduced measurement variability. IPMI SWE should be developed to improve examination quality and reliability in obese patients.
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