Details

Autor(en) / Beteiligte

• Pierce, Theodore T
• Ozturk, Arinc
• Sherlock, Sarah P
• Moura Cunha, Guilherme
• Wang, Xiaohong
• Li, Qian
• Hunt, David
• Middleton, Michael S
• Martin, Marian
• Corey, Kathleen E
• Edenbaum, Hannah
• Shankar, Sudha S
• Heymann, Helen
• Kamphaus, Tania N
• Calle, Roberto A
• Covarrubias, Yesenia
• Loomba, Rohit
• Obuchowski, Nancy A
• Sanyal, Arun J
• Sirlin, Claude B
• Fowler, Kathryn J
• Samir, Anthony E
• Katz, Douglas

Titel

Reproducibility and Repeatability of US Shear-Wave and Transient Elastography in Nonalcoholic Fatty Liver Disease

Ist Teil von

• Radiology, 2024-09, Vol.312 (3), p.e233094

Ort / Verlag

United States

Erscheinungsjahr

2024

Quelle

MEDLINE

Beschreibungen/Notizen

• Background US shear-wave elastography (SWE) and vibration-controlled transient elastography (VCTE) enable assessment of liver stiffness, an indicator of fibrosis severity. However, limited reproducibility data restrict their use in clinical trials. Purpose To estimate SWE and VCTE measurement variability in nonalcoholic fatty liver disease (NAFLD) within and across systems to support clinical trial diagnostic enrichment and clinical interpretation of longitudinal liver stiffness. Materials and Methods This prospective, observational, cross-sectional study (March 2021 to November 2021) enrolled adults with NAFLD, stratified according to the Fibrosis-4 (FIB-4) index (≤1.3, >1.3 and <2.67, ≥2.67), at two sites to assess SWE with five US systems and VCTE with one system. Each participant underwent 12 elastography examinations over two separate days within 1 week, with each day's examinations conducted by a different operator. VCTE and SWE measurements were reported in units of meters per second. The primary end point was the different-day, different-operator reproducibility coefficient (RDC ) pooled across systems for SWE and individually for VCTE. Secondary end points included system-specific RDC , same-day, same-operator repeatability coefficient (RC ), and between-system same-day, same-operator reproducibility coefficient. The planned sample provided 80% power to detect a pooled RDC of less than 35%, the prespecified performance threshold. Results A total of 40 participants (mean age, 60 years ± 10 [SD]; 24 women) with low ( = 17), intermediate ( = 15), and high ( = 8) FIB-4 scores were enrolled. RDC was 30.7% (95% upper bound, 34.4%) for SWE and 35.6% (95% upper bound, 43.9%) for VCTE. SWE system-specific RDC varied from 24.2% to 34.3%. The RC was 21.0% for SWE (range, 13.9%-35.0%) and 19.6% for VCTE. The SWE between-system same-day, same-operator reproducibility coefficient was 52.7%. Conclusion SWE met the prespecified threshold, RDC less than 35%, with VCTE having a higher RDC . SWE variability was higher between different systems. These estimates advance liver US-based noninvasive test qualification by defining expected variability, establishing that serial examination variability is lower when performed with the same system, and informing clinical trial design. ClinicalTrials.gov Identifier NCT04828551 © RSNA, 2024