Department of Radiology, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Republic of Korea.
Department of Radiology, Asan Medical Center, Seoul, Republic of Korea.
Contrast Media Mol Imaging. 2021 Oct 31;2021:4764348. doi: 10.1155/2021/4764348. eCollection 2021.
Contrast-enhanced MR (CE-MR) imaging is often required to improve lesion detection and characterization and to increase diagnostic confidence. This study aimed to evaluate the safety and effectiveness, as well as the use pattern, of the macrocyclic gadolinium-based contrast agent Clariscan in real-world clinical practice in Korea.
This was a prospective, multicenter, observational study of patients undergoing CE-MR as part of routine clinical care at 6 university hospitals in Korea. Effectiveness was evaluated by determining diagnostic confidence and image quality; safety evaluation included the adverse event (AE) expression rate. Subgroup analyses were conducted by body regions of diagnosis (musculoskeletal, nervous system, others) and in pediatric patients (aged ≤7 years).
From October 2019 to September 2020, 1,376 subjects were included in the study. The mean volume of Clariscan used was 0.26 mL/kg (0.13 mmol/kg). In the overall study population and in each subgroup, diagnostic confidence increased after contrast enhancement with Clariscan. Overall, image quality was excellent in 72.5% of subjects and good-to-adequate in 27.2%. Clariscan was well tolerated (14 AEs occurred in 10 subjects); all AEs were of mild severity. Subgroup analyses showed that the mean dose of Clariscan used was ≥0.1 mmol/kg for nervous system-related diagnoses (e.g., brain) and ≤0.1 mmol/kg for musculoskeletal and pediatric-related diagnoses. All musculoskeletal and pediatric examinations were provided with a smaller package of 5 mL Clariscan. By body region of MR examination, the most common region was the nervous system in 69.0%, musculoskeletal system in 13.6%, and reproductive system in 4.9%.
This study confirmed the use pattern of Clariscan and its excellent effectiveness and safety in the real-world clinical environment in Korea. The small-dose package indicated the possibility of increasing the convenience and efficiency of drug use.
对比增强磁共振（CE-MR）成像通常需要提高病变检测和特征描述的能力，并增加诊断的信心。本研究旨在评估大环钆基对比剂 Clariscan 在韩国真实临床实践中的安全性和有效性，以及使用模式。
这是一项在韩国 6 家大学医院进行的前瞻性、多中心、观察性研究，纳入了因常规临床需要接受 CE-MR 检查的患者。通过确定诊断信心和图像质量来评估有效性；安全性评估包括不良事件（AE）发生率。通过诊断部位（肌肉骨骼、神经系统、其他）和儿科患者（≤7 岁）进行亚组分析。
从 2019 年 10 月至 2020 年 9 月，共有 1376 例患者纳入研究。Clariscan 的平均用量为 0.26ml/kg（0.13mmol/kg）。在总体研究人群和每个亚组中，增强后诊断信心均增加。总体而言，72.5%的患者图像质量优秀，27.2%的患者图像质量良好至足够。Clariscan 具有良好的耐受性（10 例患者发生 14 例 AE）；所有 AE 均为轻度。亚组分析显示，对于与神经系统相关的诊断（如大脑），Clariscan 的平均剂量≥0.1mmol/kg，而对于肌肉骨骼和儿科相关的诊断，Clariscan 的平均剂量≤0.1mmol/kg。所有肌肉骨骼和儿科检查均使用 5ml Clariscan 的小包装。按磁共振检查的身体部位，最常见的部位是神经系统，占 69.0%，肌肉骨骼系统占 13.6%，生殖系统占 4.9%。
本研究证实了 Clariscan 在韩国真实临床环境中的使用模式及其优异的有效性和安全性。小剂量包装表明增加药物使用便利性和效率的可能性。
