Abstract
Objective 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. Materials and Methods 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). Results 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%. Conclusions 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.
Highlights
Contrast-enhanced magnetic resonance (CE-MR) imaging is often required to improve lesion detection and characterization and to increase confidence in diagnosis [1]
Its use has been approved in more than 80 countries for numerous indications [3, 4]. It was approved by the US Food and Drug Administration (FDA) in March 2013 for use in the imaging of cerebral and Contrast Media & Molecular Imaging spinal lesions and associated tissues with disrupted bloodbrain barrier or abnormal vascularity in adults and children aged more than 2 years [5]. e macrocyclic structure of gadoterate meglumine provides greater chelate stability and a lower propensity to gadolinium release compared with other linear-structured gadolinium-based contrast agent (GBCA) [6]
Macrocyclic GBCA is deemed as a safe choice, the selection and use of GBCA in the post-NSF era is expected to be more careful in terms of the type and dose of GBCA in clinical settings [9]
Summary
Contrast-enhanced MR (CE-MR) imaging is often required to improve lesion detection and characterization and to increase diagnostic confidence. is 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. Is 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. 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). In the overall study population and in each subgroup, diagnostic confidence increased after contrast enhancement with Clariscan. 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. Is study confirmed the use pattern of Clariscan and its excellent effectiveness and safety in the real-world clinical environment in Korea. Conclusions. is study confirmed the use pattern of Clariscan and its excellent effectiveness and safety in the real-world clinical environment in Korea. e small-dose package indicated the possibility of increasing the convenience and efficiency of drug use
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