Multicenter validation of spin-density projection-assisted R2-MRI for the noninvasive measurement of liver iron concentration
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John Wiley and Sons Inc
Abstract
Purpose: Magnetic resonance imaging (MRI)-based techniques for assessing liver iron concentration (LIC) have been limited by single scanner calibration against biopsy. Here, the calibration of spin-density projection-assisted (SDPA) R2-MRI (FerriScan®) in iron-overloaded β-thalassemia patients treated with the iron chelator, deferasirox, for 12 months is validated. Methods: SDPA R2-MRI measurements and percutaneous needle liver biopsy samples were obtained from a subgroup of patients (n=233) from the ESCALATOR trial. Five different makes and models of scanner were used in the study. Results LIC, derived from mean of MRI- and biopsy-derived values, ranged from 0.7 to 50.1 mg Fe/g dry weight. Mean fractional differences between SDPA R2-MRI- and biopsy-measured LIC were not significantly different from zero. They were also not significantly different from zero when categorized for each of the Ishak stages of fibrosis and grades of necroinflammation, for subjects aged 3 to <8 versus ≥8 years, or for each scanner model. Upper and lower 95% limits of agreement between SDPA R2-MRI and biopsy LIC measurements were 74 and -71%. Conclusion: The calibration curve appears independent of scanner type, patient age, stage of liver fibrosis, grade of necroinflammation, and use of deferasirox chelation therapy, confirming the clinical usefulness of SDPA R2-MRI for monitoring iron overload. © 2013 Wiley Periodicals, Inc.
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Biopsy, Deferasirox, Escalator, Iron overload, Β-thalassemia, Adolescent, Adult, Benzoates, Biopsy, needle, Calibration, Chelation therapy, Child, Child, preschool, Female, Humans, Iron, Iron chelating agents, Liver, Magnetic resonance imaging, Male, Prospective studies, Treatment outcome, Triazoles, Chelation, Convolution, Escalators, Patient monitoring, Patient treatment, Scanning, Deferiprone, Deferoxamine, Benzoic acid derivative, Iron chelating agent, Triazole derivative, Calibration curves, Iron chelators, Iron concentrations, Iron overloads, Liver fibrosis, Noninvasive measurements, Scanner calibration, Article, Beta thalassemia, Comparative study, Diagnostic test accuracy study, Drug liver level, Dry weight, Hepatitis, Human, Liver biopsy, Liver necrosis, Major clinical study, Monotherapy, Non invasive procedure, Nuclear magnetic resonance imaging, Nuclear magnetic resonance scanner, Open study, Prospective study, Reproducibility, Spin density projection assisted magnetic resonance imaging, Treatment duration, Validity, Clinical trial, Metabolism, Multicenter study, Needle biopsy, Preschool child, Procedures, Validation study