Diagnostic efficacy and safety of gadoteridol compared to gadobutrol and gadoteric acid in a large sample of CNS MRI studies at 1.5T

• Published in: Journal of neuroradiology Vol. 49; no. 1; pp. 73 - 79
• Main Authors: del Poggio, Anna, Anello, Giulia, Calloni, Sonia Francesca, Vezzulli, Paolo, Pereira, Clodoaldo, Iadanza, Antonella, Falini, Andrea, Anzalone, Nicoletta
• Format: Journal Article
• Language: English
• Published: France Elsevier Masson SAS 01.01.2022
• Subjects: Adult; Aged; Central nervous system; Contrast Media - adverse effects; Gadolinium; Gadolinium-based contrast agents (GBCA); Gadoteridol; Heterocyclic Compounds; Humans; Magnetic Resonance Imaging; Middle Aged; MRI; Organometallic Compounds - adverse effects; MRI; Central nervous system; FN; CNS; FP; CE-MRI; NPV; Gadolinium-based contrast agents (GBCA); Gadoteridol; PPV; EMA; TN; TP; GBCAs; Gd
• ISSN: 0150-9861
• DOI: 10.1016/j.neurad.2020.06.005

[Display omitted] •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. 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. 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. 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. 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.