Please cite this article in press as: del Poggio A, et al, Diagnostic efficacy and safety of gadoteridol compared to gadobutrol and gadoteric acid in a large sample of CNS MRI studies at 1.5 T, J Neuroradiol (2020), https://doi.org/10.1016/j.neurad.2020.06.005 ARTICLE IN PRESS G Model NEURAD-920; No. of Pages 7 Journal of Neuroradiology xxx (2020) xxx–xxx Available online at ScienceDirect www.sciencedirect.com Original article Diagnostic efficacy and safety of gadoteridol compared to gadobutrol and gadoteric acid in a large sample of CNS MRI studies at 1.5 T Anna del Poggio a , Giulia Anello b , Sonia Francesca Calloni a , Paolo Vezzulli a , Clodoaldo Pereira a , Antonella Iadanza a , Andrea Falini a , Nicoletta Anzalone a,∗ a Department of Neuroradiology and CERMAC, San Raffaele Scientific Institute, San Raffaele Vita-Salute University, Milan, Italy b Sapienza University of Rome, Rome, Italy a r t i c l e i n f o Article history: Available online xxx Keywords: MRI Gadoteridol Central nervous system Gadolinium-based contrast agents (GBCA) a b s t r a c t 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 consecu- tive cohort of patients referred for neuroradiological CE-MRI (1.5 T 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 (220 M/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%, respec- tively, 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 malig- nancy 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. © 2020 Published by Elsevier Masson SAS. Introduction The current suspension in Europe of certain linear gadolinium- based contrast agents (GBCAs) due to concern over the potential long-term consequences of retained gadolinium (Gd) in the brain [1] has led to the mandatory use of macrocyclic agents for all extra-hepatic magnetic resonance imaging procedures that require Abbreviations: EMA, European Medicines Agency; GBCAs, gadolinium-based contrast agents; Gd, gadolinium; CE-MRI, Contrast-enhanced Magnetic Resonance Imaging; CNS, central nervous system; TP, true positive; TN, true negative; FP, false positive; FN, false negative; PPV, positive predictive value; NPV, negative predictive value. ∗ Corresponding author at: San Raffaele Vita-Salute University, Via Olgettina 60, Milan, Italy. E-mail address: anzalone.nicoletta@hsr.it (N. Anzalone). contrast enhancement. The decision of the European Medicines Agency (EMA) necessitated a switch away from the high relaxivity GBCA gadobenate dimeglumine (Bracco) for neuro MRI applica- tions to gadobutrol (Gadovist; Bayer), gadoteric acid (Dotarem; Guerbet) or gadoteridol (ProHance; Bracco) [1]. These three macro- cyclic GBCAs have similar rates of adverse events as determined in multi-centre, prospective, observational studies [2–5], and similar r1 relaxivity values of approximately 4.6, 3.9 and 4.4 L•mmol -1 •sec -1 (gadobutrol, gadoteric acid, gadoteridol, respec- tively, at 1.5 T) implying similar imaging performance [6]. However, whereas extensive real-word data are available for gadobutrol and gadoteric acid, much less was known about gadoteridol, par- ticularly with regards to diagnostic performance in daily clinical routine. The aim of our study was to prospectively evaluate the safety and efficacy of gadoteridol in a consecutive, non-selected and real https://doi.org/10.1016/j.neurad.2020.06.005 0150-9861/© 2020 Published by Elsevier Masson SAS.