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Nicolas F Michoux, Nicolas F Michoux, Jakub Ceranka, Jakub Ceranka, Jef Vandemeulebroucke, Jef Vandemeulebroucke, Frank Peeters, Frank Peeters, Pierre Lu, Pierre Lu, Julie Absil, Julie Absil, Perrine Triqueneaux, Perrine Triqueneaux, Laurence Collette, Laurence Collette, , , Carola Brussaard, Carola Brussaard, , , , , Hubert Raeymaekers, Hubert Raeymaekers, , , Thierry Metens, Thierry Metens, Frédéric E Lecouvet, Frédéric E Lecouvet
 

Contribution to journal

Abstract ■

OBJECTIVES: Multicenter oncology trials increasingly include MRI examinations with apparent diffusion coefficient (ADC) quantification for lesion characterization and follow-up. However, the repeatability and reproducibility (R\&R) limits above which a true change in ADC can be considered relevant are poorly defined. This study assessed these limits in a standardized whole-body (WB)-MRI protocol.METHODS: A prospective, multicenter study was performed at three centers equipped with the same 3.0-T scanners to test a WB-MRI protocol including diffusion-weighted imaging (DWI). Eight healthy volunteers per center were enrolled to undergo test and retest examinations in the same center and a third examination in another center. ADC variability was assessed in multiple organs by two readers using two-way mixed ANOVA, Bland-Altman plots, coefficient of variation (CoV), and the upper limit of the 95\% CI on repeatability (RC) and reproducibility (RDC) coefficients.RESULTS: CoV of ADC was not influenced by other factors (center, reader) than the organ. Based on the upper limit of the 95\% CI on RC and RDC (from both readers), a change in ADC in an individual patient must be superior to 12\% (cerebrum white matter), 16\% (paraspinal muscle), 22\% (renal cortex), 26\% (central and peripheral zones of the prostate), 29\% (renal medulla), 35\% (liver), 45\% (spleen), 50\% (posterior iliac crest), 66\% (L5 vertebra), 68\% (femur), and 94\% (acetabulum) to be significant.CONCLUSIONS: This study proposes R\&R limits above which ADC changes can be considered as a reliable quantitative endpoint to assess disease or treatment-related changes in the tissue microstructure in the setting of multicenter WB-MRI trials.KEY POINTS: • The present study showed the range of R\&R of ADC in WB-MRI that may be achieved in a multicenter framework when a standardized protocol is deployed. • R\&R was not influenced by the site of acquisition of DW images. • Clinically significant changes in ADC measured in a multicenter WB-MRI protocol performed with the same type of MRI scanner must be superior to 12\% (cerebrum white matter), 16\% (paraspinal muscle), 22\% (renal cortex), 26\% (central zone and peripheral zone of prostate), 29\% (renal medulla), 35\% (liver), 45\% (spleen), 50\% (posterior iliac crest), 66\% (L5 vertebra), 68\% (femur), and 94\% (acetabulum) to be detected with a 95\% confidence level.

Reference ■