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, Akio; Masumoto, T.; Yamada, Hideaki; Kurauchi, Masayo; Breuer, Josy

doi:10.2463/mrms.mp.2015-0083

Cited by 4 publications

(4 citation statements)

References 18 publications

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“…Pivotal phase 3 [ 20 – 24 ] and 4 [ 25 , 26 ] trials have firmly established the diagnostic efficacy of gadobutrol in adult patients undergoing diagnostic CE MRI of brain lesions (Table 2 ), including for diagnosing primary and metastatic brain tumours. With the exception of the REMIND trial in patients with primary brain tumours [ 25 ] and a phase 3 trial in patients with known or suspected brain metastases [ 24 ], all other trials included patients with primary or metastatic brain tumours [ 20 – 23 , 26 ] and, in some instances, also included patients with non-tumour brain lesions (e.g. white matter disease, vascular lesions, infarct, haemorrhage, infective/inflammatory disease) [ 20 , 21 , 26 ].…”

Section: Diagnostic Efficacy Of Gadobutrolmentioning

confidence: 99%

“…of detected lesions/pt 2.97 vs. 2.65 (NI) c ; LCE 2.86 vs. 0.93*** (SUP) c ; LBD 2.94 vs. 1.92*** (SUP) c ; LIM 2.35 vs. 1.57*** (SUP) c Katakami et al [ 24 ] (151) GAD 0.1 and 0.2 vs. GAT 0.2 Overall % rated as good or excellent: LCE ≥ 86 and ≥ 90 vs. ≥ 87; LBD ≥ 67 and ≥ 74 vs. ≥ 71 No. of detected lesions/pt c 6.28 and 6.92 vs. 6.87 (NI) Tanaka et al [ 23 ] (221) GAD 0.1 d vs. UMRI No. of detected lesions/pt 11.09 vs. 10.79 (NI) c LCE 2.87 vs. 0.95*** (SUP) c ; LBD 3.20 vs. 2.14*** c ; LIM 2.28 vs. 1.15*** (SUP) c Phase 4 trials REMIND [ 25 ] (234) GAD 0.1 vs. GAD-ME 0.1 % rated as good or excellent for overall lesion visualization and characterization (range across readers): 93.2–99.6 vs. 90.6–100% c (NI) LSM BGD (range across readers): SNR − 10.3 to − 14.6 e ; CNR − 7.4 to − 23.6 e ; % LCE − 13.2 to − 15.7 e Generally, readers had no specific preference for GAD vs. GAD-ME for LBD, LIM, LCE; no difference for diagnostic confidence TRUTH [ 26 ] (209) GAD 0.1 vs. GAT 0.1 Generally, readers had no specific preference for GAD vs. GAT for global diagnostic preference, disease extent, LBD, LIM or LCE No BGD in % LCE, pre- to post-dose change in lesion-to-background ratio or no.…”

Section: Diagnostic Efficacy Of Gadobutrolmentioning

confidence: 99%

“…In phase 3 trials, the diagnostic efficacy of combined gadobutrol-enhanced plus unenhanced MRI was noninferior to unenhanced MRI for the mean number of lesions detected/patient (primary quantitative outcome) and superior to unenhanced MRI for qualitative primary outcomes of lesion contrast enhancement (LCE), border delineation (LBD) and internal morphology (LIM) (Table 2 ) [ 20 , 21 , 23 ]. There was no loss of specificity, exact-match diagnostic accuracy or reader confidence associated with gadobutrol-enhanced improvements in the sensitivity and accuracy of malignant lesion detection [ 21 , 23 ].…”

Section: Diagnostic Efficacy Of Gadobutrolmentioning

confidence: 99%

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Gadobutrol: A Review in Contrast-Enhanced MRI and MRA

Scott¹

2018

Clin Drug Investig

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Intravenous gadobutrol [Gadovist™ (EU); Gadavist® (USA)] is a second-generation, extracellular non-ionic macrocyclic gadolinium-based contrast agent (GBCA) that is approved for use in paediatric (including term neonates) and adult patients undergoing diagnostic contrast-enhanced (CE) MRI for visualization of pathological lesions in all body regions or for CE MRA to evaluate perfusion and flow-related abnormalities. Its unique physicochemical profile, including its high thermostability and proton relaxation times, means that gadobutrol is formulated at twice the gadolinium ion concentration of other GBCAs, resulting in a narrower bolus and consequently, improved dynamic image enhancement. Based on >  20 years of experience in the clinical trial and real-world settings (>  50 million doses) and its low risk for developing nephrogenic systemic fibrosis (NSF), gadobutrol represents an effective and safe diagnostic GBCA for use in CE MRI and MRA to visualize pathological lesions and vascular perfusion and flow-related abnormalities in all body regions in a broad spectrum of patients, including term neonates and other paediatric patients, young and elderly adult patients, and those with moderate or severe renal or hepatic impairment or cardiovascular (CV) disease.

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Section: Diagnostic Efficacy Of Gadobutrolmentioning

confidence: 99%

Section: Diagnostic Efficacy Of Gadobutrolmentioning

confidence: 99%

Section: Diagnostic Efficacy Of Gadobutrolmentioning

confidence: 99%

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Gadobutrol: A Review in Contrast-Enhanced MRI and MRA

Scott¹

2018

Clin Drug Investig

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“…In order for such predictions of genetics and endocrine status to be accurate, the MRI techniques must be as sensitive as possible. To enhance the contrast of MRI scans, intravenous gadolinium-based agents have routinely been administered to patients for more than 20 years and were generally considered safe ( 38 , 39 , 40 ). However, studies have indicated that gadolinium may be retained in the body, particularly in the brain when administered for pituitary imaging, so that after multiple administrations the contrast agents remained and deposits could be identified ( 40 , 41 ).…”

Section: Cranial Imagingmentioning

confidence: 99%

Important Tools for Use by Pediatric Endocrinologists in the Assessment of Short Stature

Labarta¹,

Ranke²,

Maghnie³

et al. 2021

Jcrpe

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Assessment and management of children with growth failure has improved greatly over recent years. However, there remains a strong potential for further improvements by using novel digital techniques. A panel of experts discussed developments in digitalization of a number of important tools used by pediatric endocrinologists at the third 360° European Meeting on Growth and Endocrine Disorders, funded by Merck KGaA, Germany, and this review is based on those discussions. It was reported that electronic monitoring and new algorithms have been devised that are providing more sensitive referral for short stature. In addition, computer programs have improved ways in which diagnoses are coded for use by various groups including healthcare providers and government health systems. Innovative cranial imaging techniques have been devised that are considered safer than using gadolinium contrast agents and are also more sensitive and accurate. Deep-learning neural networks are changing the way that bone age and bone health are assessed, which are more objective than standard methodologies. Models for prediction of growth response to growth hormone (GH) treatment are being improved by applying novel artificial intelligence methods that can identify non-linear and linear factors that relate to response, providing more accurate predictions. Determination and interpretation of insulin-like growth factor-1 (IGF-1) levels are becoming more standardized and consistent, for evaluation across different patient groups, and computer-learning models indicate that baseline IGF-1 standard deviation score is among the most important indicators of GH therapy response. While physicians involved in child growth and treatment of disorders resulting in growth failure need to be aware of, and keep abreast of, these latest developments, treatment decisions and management should continue to be based on clinical decisions. New digital technologies and advancements in the field should be aimed at improving clinical decisions, making greater standardization of assessment and facilitating patient-centered approaches.

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Clinical Efficacy of Gadobutrol: Review of Over 25 Years of Use Exceeding 100 Million Administrations

Endrikat,

Gutberlet,

Barkhausen

et al. 2023

Invest Radiol

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Background Gadobutrol has been administered more than 100 million times worldwide, since February 1998, that is, over the last 25 years. Numerous clinical studies in a broad range of indications document the long-term experience with gadobutrol. Objective The aim of this study was to provide a literature-based overview on gadobutrol's efficacy in 9 approved indications and use in children. Materials and Methods Efficacy results in patients of all age groups including sensitivity, specificity, accuracy, and positive/negative predictive values were identified by a systematic literature search on Embase until December 31, 2022. Nine approved indications were considered: central nervous system (CNS), magnetic resonance angiography (MRA), breast, heart, prostate, kidney, liver, musculoskeletal, whole body, and various indications in children. Results Sixty-five publications (10 phase III, 2 phase IV, 53 investigator-initiated studies) reported diagnostic efficacy results obtained from 7806 patients including 271 children, at 369 centers worldwide. Indication-specific sensitivity ranges were 59%–98% (CNS), 53%–100% (MRA), 80%–100% (breast), 64%–90% (heart), 64%–96% (prostate), 71–85 (kidney), 79%–100% (liver), 53%–98% (musculoskeletal), and 78%–100% (children). Indication-specific specificity ranges were 75%–100% (CNS), 64%–99% (MRA), 58%–98% (breast), and 47%–100% (heart). Conclusions The evaluated body of evidence, consisting of 65 studies with 7806 patients, including 271 children and 7535 adults, showed that gadobutrol is an efficacious magnetic resonance imaging contrast agent for all age groups in various approved indications throughout the whole body.

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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

Cited by 4 publications

References 18 publications

Gadobutrol: A Review in Contrast-Enhanced MRI and MRA

Gadobutrol: A Review in Contrast-Enhanced MRI and MRA

Important Tools for Use by Pediatric Endocrinologists in the Assessment of Short Stature

Clinical Efficacy of Gadobutrol: Review of Over 25 Years of Use Exceeding 100 Million Administrations

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