Abstract

To compare the reproducibility and accuracy of R2-relaxometry MRI for estimationof liver iron concentration (LIC) between in-house analysis and FDA-approved commercially available third party results. All MR studies were performed on a 1.5T scanner.Multi-echo spin-echo scans with a fixed TR and increasing TE values of 6ms, 9ms, 12ms, 15ms, and 18ms (spaced at 3ms intervals) were used. Post-processing of the images to calculate mean relaxivity, R2, included drawing of regions of interest to include the whole liver on mid-slice. The relationship between liver R2 values and estimated LIC calculated with in-house analysis and valuesreported by an external company (FerriScan®, Resonance Health, Australia) were assessed with correlation coefficients and Bland-Altman difference plots. Continuous variables are presented as mean ± standard deviation. Significance was set at p value < 0.05. 474 studies from 175 patients were included in the study (mean age 10.4 ± 4.2years (range 1-18years); 254 studies from girls, 220 studies from boys). LIC ranged from 0.6 to 43mg/g dry tissue, covering a broad range from normal levels to extremely high iron levels. Linearity between proprietary and in-house methods was excellent across the observed range for R2 (31.5 to 334.8s-1); showing a correlation coefficient of r = 0.87, p < 0.001. Bland-Altman R2 difference plot between the two methods shows a mean bias of + 21.5s-1 (range - 47.0 to + 90.0s-1 between two standard deviations). LIC reported by FerriScan® compared with LIC estimated in-house with R2 as reported by FerriScan® agreed strongly, (r = 1.0, p < 0.001). R2 relaxometry MR imaging for liver iron concentration estimation is reproducible between proprietary FDA-approved commercial software and in-house analysis methods.

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