Phase 3 efficacy and safety trial of gadobutrol, a 1.0 molar macrocyclic MR imaging contrast agent, in patients referred for contrast‐enhanced MR imaging of the central nervous system

Gutiérrez, Juan Escribano; Rosenberg, Martin; Duhaney, Michael; Simon, John; Brueggenwerth, Guenther; Agris, Jacob; Knopp, Edmond A.

doi:10.1002/jmri.24583

Cited by 9 publications

(15 citation statements)

References 21 publications

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“…The type and incidence rate of ADRs in children aged younger than 2 years was in the same range as that observed in previous clinical studies of gadobutrol in older children and adults. 15,32,33 Although young children requiring an MRI scan frequently have serious underlying conditions requiring concomitant medication and typically requiring anesthetics/sedatives to undergo imaging procedures, 9 safety outcomes obtained in this study are consistent with previous reports from observational clinical studies of gadobutrol in children and adults 4,20 and other studies with GBCAs in children. 34,35 The safety evaluations in this study confirmed a very good safety profile of a standard dose of 0.1 mmol/kg BW of gadobutrol in newborns, infants, and toddlers as in the older pediatric population and adults.…”

Section: Discussionsupporting

confidence: 92%

Pharmacokinetics and Safety of Macrocyclic Gadobutrol in Children Aged Younger Than 2 Years Including Term Newborns in Comparison to Older Populations

Kunze

Mentzel

Krishnamurthy

et al. 2016

Investigative Radiology

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The PK profile of gadobutrol in children aged younger than 2 years including newborns is similar to that in older children and adults. At the dose of 0.1 mmol/kg BW, gadobutrol had a favorable safety profile and was well tolerated with similar profile across the age range 0 to younger than 2 years and compared with older children and adults. Extrapolation of efficacy data from adults to the younger pediatric population, including term newborns, is justified. The recommended standard dose of gadobutrol (0.1 mmol/kg BW), as used in the population aged 2 years and older, is also appropriate in children aged younger than 2 years.

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Section: Discussionsupporting

confidence: 92%

Pharmacokinetics and Safety of Macrocyclic Gadobutrol in Children Aged Younger Than 2 Years Including Term Newborns in Comparison to Older Populations

Kunze

Mentzel

Krishnamurthy

et al. 2016

Investigative Radiology

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“…The non-inferiority margin was set as 0.35, and the expected mean and standard deviation (0.39 and 3.12, respectively) were assumed taken from two previous global clinical studies. 8 , 9 …”

Section: Methodsmentioning

confidence: 99%

“… 3 – 7 The safety and tolerability of gadobutrol have been shown in clinical trials and post-marketing evidence. 8 – 13 As a macrocyclic agent, gadobutrol is more stable compared with linear GBCAs, which are associated with an increased risk of nephrogenic systemic fibrosis in patients with severely impaired renal function. 11 , 14 – 16 …”

Section: Introductionmentioning

confidence: 99%

“…This Japanese study was prospectively planned in reference to another global confirmatory study for the general CNS indication performed in the United States, South America, China, and Korea, in which the efficacy of gadobutrol was demonstrated. 8 The primary objectives of this study were to demonstrate that the efficacy and safety of gadobutrol in CNS MRI is also evident in Japanese patients.…”

Section: Introductionmentioning

confidence: 99%

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A Japanese, Multicenter, Open-label, Phase 3 Study to Investigate the Safety and Efficacy of Gadobutrol for Contrast-enhanced MR Imaging of the Central Nervous System

Tanaka

Masumoto

Yamada

et al. 2016

MRMS

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Purpose:Gadobutrol 1.0 M is macrocyclic gadolinium-based contrast agent for magnetic resonance imaging (MRI). This multicenter, open-label, phase 3 study aimed to investigate the efficacy and safety of gadobutrol-enhanced versus unenhanced MRI in the visualization and diagnosis of central nervous system (CNS) lesions in Japanese patients.Methods:A total of 223 patients referred for contrast-enhanced MRI of the CNS underwent unenhanced and gadobutrol-enhanced (0.1 mmol/kg body weight) MRI. The unenhanced and combined (unenhanced and enhanced) images were evaluated by three independent readers in a blinded manner for degree of contrast enhancement, border delineation, internal morphology, and number of detected lesions (primary variables), and for primary diagnosis and diagnostic confidence. Final clinical diagnoses were established by an independent truth committee consisting of two neurosurgeons. Sensitivity, specificity, and accuracy were calculated for the detection of malignancy and the preciseness of diagnoses (secondary variables) by comparing the results obtained by the blinded readers and the truth committee.Results:Gadobutrol enhancement significantly improved three visualization parameters in MR images: contrast enhancement, border delineation, and internal morphology (P < 0.0001). Non-inferiority was achieved for mean number of lesions detected. Gadobutrol-enhanced imaging provided significant improvements in sensitivity and accuracy for the detection of malignant disease with no loss in specificity, and also improvements in accuracy of exact match diagnosis and diagnostic confidence. Drug-related adverse events were reported in 6 out of 223 patients (2.7%); all were non-serious.Conclusion:Gadobutrol is an effective and well-tolerated contrast agent for MR imaging of the CNS.

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“…It has a concentration of 1.0 mol/L (1 M), which is two times higher than other commonly used contrast agents (eg, gadopentetate dimeglumine [Gd-DTPA], 0.5 M). Additionally, gadobutrol has an inherently higher T1 relaxivity than Gd-DTPA (8)(9)(10)(11). Results from animal and human studies have demonstrated an increased detection of metastatic brain lesions by gadobutrol because of its higher concentration and relaxivity compared with the same dose of Gd-DTPA (12)(13)(14).…”

Section: Introductionmentioning

confidence: 99%

Time-Dependent Changes in the Magnetic Resonance Detection of Brain Metastases Using Single-Dose Gadobutrol

Fan¹,

Li²,

Wang³

et al. 2018

Iran J Radiol

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Objectives: The effect of delay in imaging on the assessment of contrast-enhanced magnetic resonance imaging (CE-MRI) has not been extensively studied. This study evaluated the effect of different delay times (3, 7, and 10 minutes) on gadobutrol (Gadovist)-enhanced MRI for diagnosis of brain metastases. Methods: This single-center, blind-reading, post-marketing study enrolled 52 patients with suspected or known brain metastases who received gadolinium-enhanced MR examinations. All the patients received 0.1 mmol/kg dose of gadobutrol, and serial axial T1 FLAIR images were obtained at each MR examination after a delay of 3, 7, and 10 minutes. The images were evaluated by two experienced radiologists independently. The evaluation included subjective and objective evaluations of the image quality. Results: Thirty-four patients were diagnosed with brain metastases. There were 295, 301, and 301 lesions detected in the 3, 7, and 10 minutes delay groups, respectively. Subjective evaluation revealed a higher mean quality score of lesion edge, lesion interior, and overall image quality in the 7 and 10 minutes groups compared to the 3 minutes group. Images in the 7-or 10-min delay groups had significantly greater CNR and CBR than the 3-min group (P < 0.05). Conclusions: A delay time of 7 minutes was considered optimal for imaging after gadobutrol administration in patients with brain metastases.

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Phase 3 efficacy and safety trial of gadobutrol, a 1.0 molar macrocyclic MR imaging contrast agent, in patients referred for contrast‐enhanced MR imaging of the central nervous system

Abstract: Gadobutrol 1.0M is an effective and well-tolerated contrast agent for CNS MRI.

Cited by 9 publications

References 21 publications

Pharmacokinetics and Safety of Macrocyclic Gadobutrol in Children Aged Younger Than 2 Years Including Term Newborns in Comparison to Older Populations

Pharmacokinetics and Safety of Macrocyclic Gadobutrol in Children Aged Younger Than 2 Years Including Term Newborns in Comparison to Older Populations

A Japanese, Multicenter, Open-label, Phase 3 Study to Investigate the Safety and Efficacy of Gadobutrol for Contrast-enhanced MR Imaging of the Central Nervous System

Time-Dependent Changes in the Magnetic Resonance Detection of Brain Metastases Using Single-Dose Gadobutrol

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