Patterns of use, effectiveness and safety of gadolinium contrast agents: a European prospective cross-sectional multicentre observational study

Jakobsen, Jarl Å.; Quattrocchi, Carlo Cosimo; Müller, Frank; Outteryck, Olivier; Alcázar, Andrés; Reith, Wolfgang; Fraga, Patricia; Panebianco, Valeria; Sampedro, A.; Pietura, Radosław

doi:10.1186/s12880-021-00600-9

Cited by 14 publications

(8 citation statements)

References 15 publications

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“…Consistent with the results of the present study, a 2015 review of previous studies that evaluated the safety and efficacy of gadoteric acid also showed a high level of improvement in diagnosis upon the use of gadoteric acid, with good or excellent image quality reported in 95 to 100% of cases [ 13 ]. Similar findings were reported recently in a prospective, cross-sectional, multicenter, observational study, confirming that GBCAs are used appropriately in Europe for a wide range of indications [ 14 ]. The study demonstrated a significant increase in diagnostic confidence after GBCA use and confirmed the good safety profile of GBCAs, with comparable results for all agents used (Clariscan, Dotarem (gadoteric acid), Gadovist (gadobutrol), and ProHance (gadoteridol)) [ 14 ].…”

Section: Discussionsupporting

confidence: 90%

“…Similar findings were reported recently in a prospective, cross-sectional, multicenter, observational study, confirming that GBCAs are used appropriately in Europe for a wide range of indications [ 14 ]. The study demonstrated a significant increase in diagnostic confidence after GBCA use and confirmed the good safety profile of GBCAs, with comparable results for all agents used (Clariscan, Dotarem (gadoteric acid), Gadovist (gadobutrol), and ProHance (gadoteridol)) [ 14 ].…”

Section: Discussionsupporting

confidence: 90%

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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

Moon

Cho

Hahn

et al. 2021

Contrast Media & Molecular Imaging

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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.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 90%

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

Moon

Cho

Hahn

et al. 2021

Contrast Media & Molecular Imaging

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“…The present study is a subanalysis of the data from the above European study, to assess the real-world safety and efficacy of GBCAs, including Clariscan for CNS (brain and spine) examinations at recommended/on label doses in the USA. [10]…”

Section: Methodsmentioning

confidence: 99%

“…The data for this study has been obtained from a larger scale European study, a cross-sectional multicenter observational study with prospective recruitment performed in patients scheduled for gadolinium contrast-enhanced magnetic resonance imaging (CE-MRI) as part of their routine clinical workup. [10] The study was registered on https://clinicaltrials.gov with identifier NCT01523873.…”

Section: Methodsmentioning

confidence: 99%

Gadolinium-based contrast agents for imaging of the central nervous system: A multicenter European prospective study

Behzadi

McDonald

2022

Medicine

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Contrast-enhanced MR (CE-MR) imaging is required to improve lesion detection and characterization and to increase diagnostic confidence. This study aims to evaluate the safety, effectiveness, and usage patterns of recently introduced ClariscanTM (gadoterate meglumine) and other macrocyclic gadolinium-based contrast agents (GBCAs) used for magnetic resonance imaging (MRI) of the central nervous system (CNS). Data was obtained from a European multicenter, prospective, observational postmarketing study that included pediatric and adult patients undergoing contrast-enhanced MRI with a GBCA used in routine clinical practice. Safety data was collected by spontaneous patient adverse event (AE) reporting. Effectiveness was assessed via changes in radiological diagnosis, diagnostic confidence, and image quality. 766 patients with CNS-related indications were included from 8 centers across 5 European countries between December 2018 and November 2019. Clariscan (gadoterate meglumine) was used in 66% (503) of exams, Dotarem® (gadoterate meglumine) in 20% (160), Gadovist® (gadobutrol) in 13% (97), and ProHance® (gadoteridol) in 1%. GBCA use increased the diagnostic confidence in 95% (724/766) of patients and a change in radiological diagnosis in 65% (501/766) of patients. The Clariscan-specific data revealed an increase in diagnostic confidence in 94% (472/503) of patients and resulted in a change in radiological diagnosis in 58% (293/503) of patients. Image quality was considered excellent or good in 95% of patients across all GBCAs and in 94% of patients who received Clariscan. No AEs were reported in this cohort including Clariscan. This data demonstrates the excellent safety and efficacy profile of Clariscan and other GBCAs used in MRI examination of the CNS.

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“…1 Gadolinium-based contrast agents (GBCAs) are widely used for contrast-enhanced magnetic resonance imaging in over 450 million patients worldwide. 1 Gadolinium-based contrast agents are classified into extracellular fluid (ECF), hepatobiliary, and blood-pool agents by their biodistribution profile. 2,3 Popular GBCAs (eg, gadobutrol…”

mentioning

confidence: 99%

Safety, Tolerability, and Pharmacokinetics of a Novel Macrocyclic Gadolinium-Based Contrast Agent, HNP-2006, in Healthy Subjects

et al. 2024

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Objectives Gadolinium-based contrast agents (GBCAs) are indispensable in contrast-enhanced magnetic resonance imaging. A higher risk of gadolinium deposition in linear GBCAs required the introduction of macrocyclic GBCAs with a stable molecular structure. We conducted the first-in-human study to evaluate the safety, tolerability, and pharmacokinetics (PKs) of HNP-2006, a novel macrocyclic GBCA, in healthy male subjects. Materials and Methods A randomized, placebo-controlled, double-blind, single-ascending dose study was conducted. Subjects received either a single intravenous bolus injection of HNP-2006 or its matching placebo with a treatment-to-placebo ratio of 6:2 at the dose level of 0.02, 0.05, 0.1, 0.2, and 0.3 mmol/kg. Safety was assessed through routine clinical assessments. Blood sampling and urine collection were performed up to 72 hours postdose for PK assessments. Noncompartmental methods were used to calculate PK parameters, and a population PK model was constructed. Results Overall, 40 subjects completed the study. Fourteen subjects reported 22 treatment-emergent adverse events (TEAEs). The severity of all TEAEs was mild, and the HNP-2006 dose was associated with the incidence of TEAEs. The most common TEAEs included nausea and dizziness, which occurred within an hour of administration. HNP-2006 was rapidly eliminated by urinary excretion with a half-life of 1.8–2.0 hours and showed a dose-proportional PK. A 2-compartment model had the best fit with the population PK analysis. Conclusions A single intravenous dose of HNP-2006 was well-tolerated and safe up to 0.30 mmol/kg. HNP-2006 was rapidly excreted in urine and exhibited dose-independent PK profiles.

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Patterns of use, effectiveness and safety of gadolinium contrast agents: a European prospective cross-sectional multicentre observational study

Cited by 14 publications

References 15 publications

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

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

Gadolinium-based contrast agents for imaging of the central nervous system: A multicenter European prospective study

Safety, Tolerability, and Pharmacokinetics of a Novel Macrocyclic Gadolinium-Based Contrast Agent, HNP-2006, in Healthy Subjects

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