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 (1.5 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%, 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.

中文翻译：

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与钆布醇和钆特酸相比，在 1.5 T 的 CNS MRI 研究的大样本中，钆特醇的诊断效力和安全性

目的

评估钆特醇与其他基于大环钆造影剂 (GBCA) 的安全性和诊断准确性，在大量连续和未选择的患者中进行 CNS CE-MRI 转诊。

材料与方法

在 2017 年 11 月至 2018 年 3 月期间，我们前瞻性地招募了一组接受神经放射学 CE-MRI（1.5  T MRI）的患者。评估图像质量和不良事件。对具有真实标准结果的患者亚组确定诊断性能。在接受钆特醇的患者和接受其他大环 GBCA 的患者之间进行了比较。计算了两位神经放射科专家之间的读者间一致性 (kappa) 以诊断恶性肿瘤。

结果

总体而言，460 名患者（220  M/240F；平均年龄 54  ±  16 岁）入组，其中 230 名接受钆特醇（第 1 组）和 230 名钆特酸或钆布醇 [ n  =  83 (36.1%) 和n  =  147 (63.9% ) ）， 分别; 第 2 组]。两组的图像质量均被评为良好或优秀。第 1 组对判断恶性肿瘤的敏感性、特异性和诊断准确率分别为 88.2%、96.5% 和 95.4%，第 2 组分别为 93.7%、97.4% 和 96.9%，组间差异无统计学意义（P  >  0.75) 用于任何测定。识别恶性肿瘤的读者间一致性非常好 [K  =  0.877 (95%CI: 0.758–0.995) 和 K 第 1 组和第 2 组分别=  0.818 (95%CI: 0.663–0.972)；P  =  0.0913]。460 名患者中有 5 名（1.09%）发生了不良事件，组间无显着差异（P  =  0.972）。

结论

与钆布醇和钆特酸相比，钆特醇是安全的，并保证了良好的图像质量，在广泛的 CNS 病变中没有显着差异。