The Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study

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 Clarisca...

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Autores principales:	Won-Jin Moon, Young Ah Cho, Seok Hahn, Hye Min Son, Sung Koo Woo, Young Han Lee
Formato:	article
Lenguaje:	EN
Publicado:	Hindawi-Wiley 2021
Materias:	Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/c79a254da0f342838aa526374ad6d6c0
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spelling	oai:doaj.org-article:c79a254da0f342838aa526374ad6d6c02021-11-08T02:35:50ZThe Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study1555-431710.1155/2021/4764348https://doaj.org/article/c79a254da0f342838aa526374ad6d6c02021-01-01T00:00:00Zhttp://dx.doi.org/10.1155/2021/4764348https://doaj.org/toc/1555-4317Objective. 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.Won-Jin MoonYoung Ah ChoSeok HahnHye Min SonSung Koo WooYoung Han LeeHindawi-WileyarticleMedical technologyR855-855.5ENContrast Media & Molecular Imaging, Vol 2021 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Won-Jin Moon Young Ah Cho Seok Hahn Hye Min Son Sung Koo Woo Young Han Lee The Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study
description	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.
format	article
author	Won-Jin Moon Young Ah Cho Seok Hahn Hye Min Son Sung Koo Woo Young Han Lee
author_facet	Won-Jin Moon Young Ah Cho Seok Hahn Hye Min Son Sung Koo Woo Young Han Lee
author_sort	Won-Jin Moon
title	The Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study
title_short	The Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study
title_full	The Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study
title_fullStr	The Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study
title_full_unstemmed	The Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study
title_sort	pattern of use, effectiveness, and safety of gadoteric acid (clariscan) in patients undergoing contrast-enhanced magnetic resonance imaging: a prospective, multicenter, observational study
publisher	Hindawi-Wiley
publishDate	2021
url	https://doaj.org/article/c79a254da0f342838aa526374ad6d6c0
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The Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study

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