Abbreviated-protocol screening MRI vs. complete-protocol diagnostic MRI for detection of hepatocellular carcinoma in patients with cirrhosis

An equivalence study using LI-RADS v2018

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Abstract

Background: The high operational cost of MRI limits its utility for hepatocellular carcinoma (HCC) screening. Abbreviated-protocol dynamic contrast-enhanced MRI (aMRI) may help lower cost while maintaining the high accuracy of complete-protocol diagnostic MRI (cMRI). Purpose: To compare aMRI to cMRI for HCC detection in cirrhosis patients. Study Type: Cross-sectional study. Study Population: Cirrhosis patients undergoing MRI for suspected HCC. Field Strength/Sequence: 1.5T and 3T; aMRI (coronal T2-weighted, axial dynamic contrast-enhanced T1-weighted fat-suppressed sequences); cMRI (aMRI sequences and unenhanced axial T2-, T1-, and diffusion-weighted sequences). Assessment: From each cMRI, an abbreviated exam was created by extracting only the aMRI sequences. Five radiologists independently reviewed aMRI and cMRI and assigned per-patient screening results by the presence/absence of any actionable observation per Liver Imaging and Reporting Data System v2018 (LI-RADS 4, 5, M, or TIV categories). Per-patient HCC status was determined by the composite reference standard of histopathology, follow-up imaging, consensus expert panel imaging review, and clinical follow-up. Statistical Tests: Interreader agreement between aMRI and cMRI was compared with that of cMRI and tested for interchangeability against a tolerance margin of 0.05. Per-patient screening sensitivity, specificity, and accuracy were compared between aMRI and cMRI and tested for equivalence against a tolerance margin of 0.05. Results: In 93 cirrhosis patients, five radiologists recorded on average 121 liver observations. Interreader screening agreement probability (and 95% confidence interval confidence interval [CI]) was 0.914 [0.900, 0.926] between aMRI and cMRI, and 0.927 [0.908, 0.942] for cMRI; their difference was within the 0.05 margin for interchangeability. In 86 patients in whom a final HCC status could be determined, the detection sensitivity and specificity of aMRI was 0.921 [0.864, 0.956] and 0.886 [0.844, 0.918], within the 5% equivalence margin to cMRI, 0.936 [0.881, 0.965] and 0.883 [0.840, 0.915], respectively. Data Conclusion: Abbreviated-protocol screening MRI is interchangeable with, and equivalent to, complete-protocol diagnostic MRI for per-patient HCC detection in cirrhosis. Level of Evidence: 4. Technical Efficacy: Stage 6. J. Magn. Reson. Imaging 2019.

Original languageEnglish (US)
JournalJournal of Magnetic Resonance Imaging
DOIs
StatePublished - Jan 1 2019

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Hepatocellular Carcinoma
Fibrosis
Confidence Intervals
Costs and Cost Analysis
Sensitivity and Specificity
Liver
Information Systems
Cross-Sectional Studies
Fats
Observation
Population

Keywords

  • abbreviated MRI
  • cirrhosis
  • early detection
  • hepatocellular carcinoma
  • LI-RADS
  • liver cancer
  • screening

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

@article{63e784aebf324e288a5befbe9b4c1336,
title = "Abbreviated-protocol screening MRI vs. complete-protocol diagnostic MRI for detection of hepatocellular carcinoma in patients with cirrhosis: An equivalence study using LI-RADS v2018",
abstract = "Background: The high operational cost of MRI limits its utility for hepatocellular carcinoma (HCC) screening. Abbreviated-protocol dynamic contrast-enhanced MRI (aMRI) may help lower cost while maintaining the high accuracy of complete-protocol diagnostic MRI (cMRI). Purpose: To compare aMRI to cMRI for HCC detection in cirrhosis patients. Study Type: Cross-sectional study. Study Population: Cirrhosis patients undergoing MRI for suspected HCC. Field Strength/Sequence: 1.5T and 3T; aMRI (coronal T2-weighted, axial dynamic contrast-enhanced T1-weighted fat-suppressed sequences); cMRI (aMRI sequences and unenhanced axial T2-, T1-, and diffusion-weighted sequences). Assessment: From each cMRI, an abbreviated exam was created by extracting only the aMRI sequences. Five radiologists independently reviewed aMRI and cMRI and assigned per-patient screening results by the presence/absence of any actionable observation per Liver Imaging and Reporting Data System v2018 (LI-RADS 4, 5, M, or TIV categories). Per-patient HCC status was determined by the composite reference standard of histopathology, follow-up imaging, consensus expert panel imaging review, and clinical follow-up. Statistical Tests: Interreader agreement between aMRI and cMRI was compared with that of cMRI and tested for interchangeability against a tolerance margin of 0.05. Per-patient screening sensitivity, specificity, and accuracy were compared between aMRI and cMRI and tested for equivalence against a tolerance margin of 0.05. Results: In 93 cirrhosis patients, five radiologists recorded on average 121 liver observations. Interreader screening agreement probability (and 95{\%} confidence interval confidence interval [CI]) was 0.914 [0.900, 0.926] between aMRI and cMRI, and 0.927 [0.908, 0.942] for cMRI; their difference was within the 0.05 margin for interchangeability. In 86 patients in whom a final HCC status could be determined, the detection sensitivity and specificity of aMRI was 0.921 [0.864, 0.956] and 0.886 [0.844, 0.918], within the 5{\%} equivalence margin to cMRI, 0.936 [0.881, 0.965] and 0.883 [0.840, 0.915], respectively. Data Conclusion: Abbreviated-protocol screening MRI is interchangeable with, and equivalent to, complete-protocol diagnostic MRI for per-patient HCC detection in cirrhosis. Level of Evidence: 4. Technical Efficacy: Stage 6. J. Magn. Reson. Imaging 2019.",
keywords = "abbreviated MRI, cirrhosis, early detection, hepatocellular carcinoma, LI-RADS, liver cancer, screening",
author = "Gaurav Khatri and Ivan Pedrosa and Lakshmi Ananthakrishnan and {Diaz De Leon III}, Alberto and Fetzer, {David T} and John Leyendecker and Amit Singal and Yin Xi and Yopp, {Adam C} and Takeshi Yokoo",
year = "2019",
month = "1",
day = "1",
doi = "10.1002/jmri.26835",
language = "English (US)",
journal = "Journal of Magnetic Resonance Imaging",
issn = "1053-1807",
publisher = "John Wiley and Sons Inc.",

}

TY - JOUR

T1 - Abbreviated-protocol screening MRI vs. complete-protocol diagnostic MRI for detection of hepatocellular carcinoma in patients with cirrhosis

T2 - An equivalence study using LI-RADS v2018

AU - Khatri, Gaurav

AU - Pedrosa, Ivan

AU - Ananthakrishnan, Lakshmi

AU - Diaz De Leon III, Alberto

AU - Fetzer, David T

AU - Leyendecker, John

AU - Singal, Amit

AU - Xi, Yin

AU - Yopp, Adam C

AU - Yokoo, Takeshi

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: The high operational cost of MRI limits its utility for hepatocellular carcinoma (HCC) screening. Abbreviated-protocol dynamic contrast-enhanced MRI (aMRI) may help lower cost while maintaining the high accuracy of complete-protocol diagnostic MRI (cMRI). Purpose: To compare aMRI to cMRI for HCC detection in cirrhosis patients. Study Type: Cross-sectional study. Study Population: Cirrhosis patients undergoing MRI for suspected HCC. Field Strength/Sequence: 1.5T and 3T; aMRI (coronal T2-weighted, axial dynamic contrast-enhanced T1-weighted fat-suppressed sequences); cMRI (aMRI sequences and unenhanced axial T2-, T1-, and diffusion-weighted sequences). Assessment: From each cMRI, an abbreviated exam was created by extracting only the aMRI sequences. Five radiologists independently reviewed aMRI and cMRI and assigned per-patient screening results by the presence/absence of any actionable observation per Liver Imaging and Reporting Data System v2018 (LI-RADS 4, 5, M, or TIV categories). Per-patient HCC status was determined by the composite reference standard of histopathology, follow-up imaging, consensus expert panel imaging review, and clinical follow-up. Statistical Tests: Interreader agreement between aMRI and cMRI was compared with that of cMRI and tested for interchangeability against a tolerance margin of 0.05. Per-patient screening sensitivity, specificity, and accuracy were compared between aMRI and cMRI and tested for equivalence against a tolerance margin of 0.05. Results: In 93 cirrhosis patients, five radiologists recorded on average 121 liver observations. Interreader screening agreement probability (and 95% confidence interval confidence interval [CI]) was 0.914 [0.900, 0.926] between aMRI and cMRI, and 0.927 [0.908, 0.942] for cMRI; their difference was within the 0.05 margin for interchangeability. In 86 patients in whom a final HCC status could be determined, the detection sensitivity and specificity of aMRI was 0.921 [0.864, 0.956] and 0.886 [0.844, 0.918], within the 5% equivalence margin to cMRI, 0.936 [0.881, 0.965] and 0.883 [0.840, 0.915], respectively. Data Conclusion: Abbreviated-protocol screening MRI is interchangeable with, and equivalent to, complete-protocol diagnostic MRI for per-patient HCC detection in cirrhosis. Level of Evidence: 4. Technical Efficacy: Stage 6. J. Magn. Reson. Imaging 2019.

AB - Background: The high operational cost of MRI limits its utility for hepatocellular carcinoma (HCC) screening. Abbreviated-protocol dynamic contrast-enhanced MRI (aMRI) may help lower cost while maintaining the high accuracy of complete-protocol diagnostic MRI (cMRI). Purpose: To compare aMRI to cMRI for HCC detection in cirrhosis patients. Study Type: Cross-sectional study. Study Population: Cirrhosis patients undergoing MRI for suspected HCC. Field Strength/Sequence: 1.5T and 3T; aMRI (coronal T2-weighted, axial dynamic contrast-enhanced T1-weighted fat-suppressed sequences); cMRI (aMRI sequences and unenhanced axial T2-, T1-, and diffusion-weighted sequences). Assessment: From each cMRI, an abbreviated exam was created by extracting only the aMRI sequences. Five radiologists independently reviewed aMRI and cMRI and assigned per-patient screening results by the presence/absence of any actionable observation per Liver Imaging and Reporting Data System v2018 (LI-RADS 4, 5, M, or TIV categories). Per-patient HCC status was determined by the composite reference standard of histopathology, follow-up imaging, consensus expert panel imaging review, and clinical follow-up. Statistical Tests: Interreader agreement between aMRI and cMRI was compared with that of cMRI and tested for interchangeability against a tolerance margin of 0.05. Per-patient screening sensitivity, specificity, and accuracy were compared between aMRI and cMRI and tested for equivalence against a tolerance margin of 0.05. Results: In 93 cirrhosis patients, five radiologists recorded on average 121 liver observations. Interreader screening agreement probability (and 95% confidence interval confidence interval [CI]) was 0.914 [0.900, 0.926] between aMRI and cMRI, and 0.927 [0.908, 0.942] for cMRI; their difference was within the 0.05 margin for interchangeability. In 86 patients in whom a final HCC status could be determined, the detection sensitivity and specificity of aMRI was 0.921 [0.864, 0.956] and 0.886 [0.844, 0.918], within the 5% equivalence margin to cMRI, 0.936 [0.881, 0.965] and 0.883 [0.840, 0.915], respectively. Data Conclusion: Abbreviated-protocol screening MRI is interchangeable with, and equivalent to, complete-protocol diagnostic MRI for per-patient HCC detection in cirrhosis. Level of Evidence: 4. Technical Efficacy: Stage 6. J. Magn. Reson. Imaging 2019.

KW - abbreviated MRI

KW - cirrhosis

KW - early detection

KW - hepatocellular carcinoma

KW - LI-RADS

KW - liver cancer

KW - screening

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U2 - 10.1002/jmri.26835

DO - 10.1002/jmri.26835

M3 - Article

JO - Journal of Magnetic Resonance Imaging

JF - Journal of Magnetic Resonance Imaging

SN - 1053-1807

ER -