Diagnostic efficacy and safety of gadoteridol compared to gadobutrol and gadoteric acid in a large sample of CNS MRI studies at 1.5 T - 19/07/20
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Graphical abstract |
Highlights |
• | Contrast-enhanced MRI plays a central role in diagnosis of neurological diseases. |
• | Previous crossover studies didn’t evaluate contrast agents in clinical practice. |
• | Gadoteridol is safe with good image quality in a wide-range of CNS-pathologies. |
Abstract |
Purpose |
To evaluate safety and diagnostic accuracy of gadoteridol vs. other macrocyclic gadolinium-based contrast agents (GBCAs) in a large cohort of consecutive and non-selected patients referred for CE-MRI of the CNS.
Material and methods |
Between November 2017 and March 2018, we prospectively enrolled a consecutive cohort of patients referred for neuroradiological CE-MRI (1.5T MRI). Image quality and adverse events were assessed. Diagnostic performance was determined for a subgroup of patients with truth standard findings available. Comparison was made between patients receiving gadoteridol and patients receiving other macrocyclic GBCAs. Inter-reader agreement (kappa) between two expert neuroradiologists was calculated for the diagnosis of malignancy.
Results |
Overall, 460 patients (220M/240F; mean age 54±16 years) were enrolled of which 230 received gadoteridol (Group 1) and 230 either gadoteric acid or gadobutrol [n=83 (36.1%) and n=147 (63.9%), respectively; Group 2]. Image quality was rated as good or excellent in both groups. The sensitivity, specificity and diagnostic accuracy for determination of malignancy was 88.2%, 96.5% and 95.4%, respectively, for Group 1 and 93.7%, 97.4% and 96.9%, respectively, for Group 2, with no significant differences between groups (P>0.75) for any determination. Inter-reader agreement for the identification of malignancy was excellent [K=0.877 (95%CI: 0.758–0.995) and K=0.818 (95%CI: 0.663–0.972) for groups 1 and 2, respectively; P=0.0913]. Adverse events occurred in 5 of 460 (1.09%) patients overall, with no significant difference (P=0.972) between groups.
Conclusion |
Gadoteridol was safe and guaranteed good image quality without significant differences when compared to gadobutrol and gadoteric acid in a wide range of CNS pathologies.
Le texte complet de cet article est disponible en PDF.Keywords : MRI, Gadoteridol, Central nervous system, Gadolinium-based contrast agents (GBCA)
Abbreviations : EMA, GBCAs, Gd, CE-MRI, CNS, TP, TN, FP, FN, PPV, NPV
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