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Reproducibility and Repeatability of US Shear-Wave and Transient Elastography in Nonalcoholic Fatty Liver Disease.
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.
Afiliación
  • Pierce TT; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Ozturk A; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Sherlock SP; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Moura Cunha G; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Wang X; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Li Q; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Hunt D; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Middleton MS; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Martin M; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Corey KE; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Edenbaum H; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Shankar SS; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Heymann H; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Kamphaus TN; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Calle RA; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Covarrubias Y; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Loomba R; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Obuchowski NA; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Sanyal AJ; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Sirlin CB; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Fowler KJ; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
  • Samir AE; From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Depart
Radiology ; 312(3): e233094, 2024 Sep.
Article en En | MEDLINE | ID: mdl-39254458
ABSTRACT
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 (RDCDDDO) pooled across systems for SWE and individually for VCTE. Secondary end points included system-specific RDCDDDO, same-day, same-operator repeatability coefficient (RCSDSO), and between-system same-day, same-operator reproducibility coefficient. The planned sample provided 80% power to detect a pooled RDCDDDO of less than 35%, the prespecified performance threshold. Results A total of 40 participants (mean age, 60 years ± 10 [SD]; 24 women) with low (n = 17), intermediate (n = 15), and high (n = 8) FIB-4 scores were enrolled. RDCDDDO was 30.7% (95% upper bound, 34.4%) for SWE and 35.6% (95% upper bound, 43.9%) for VCTE. SWE system-specific RDCDDDO varied from 24.2% to 34.3%. The RCSDSO 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, RDCDDDO less than 35%, with VCTE having a higher RDCDDDO. SWE variability was higher between different systems. These estimates advance liver US-based noninvasive test qualification by (a) defining expected variability, (b) establishing that serial examination variability is lower when performed with the same system, and (c) informing clinical trial design. ClinicalTrials.gov Identifier NCT04828551 © RSNA, 2024 Supplemental material is available for this article.
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Diagnóstico por Imagen de Elasticidad / Enfermedad del Hígado Graso no Alcohólico Idioma: En Revista: Radiology Año: 2024 Tipo del documento: Article
Texto completo
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Diagnóstico por Imagen de Elasticidad / Enfermedad del Hígado Graso no Alcohólico Idioma: En Revista: Radiology Año: 2024 Tipo del documento: Article