更新于：2024-07-01
Gadobutrol
钆布醇
更新于：2024-07-01
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 澳大利亚 (1998-12-02), |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构
分子式C18H31GdN4O9 |
InChIKeyZPDFIIGFYAHNSK-ZCTZICQLSA-K |
CAS号770691-21-9 |
关联
69
项与 钆布醇 相关的临床试验A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)
A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)
Phase II Study to Evaluate the Performance of PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Clinically Significant Prostate Cancer in Men Presenting Following a Positive Screen for Prostate Cancer
100 项与 钆布醇 相关的临床结果
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100 项与 钆布醇 相关的转化医学
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100 项与 钆布醇 相关的专利（医药）
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737
项与 钆布醇 相关的文献（医药）2024-05-01Investigative radiology
Clinical Efficacy of Gadobutrol: Review of Over 25 Years of Use Exceeding 100 Million Administrations
Article
作者: Endrikat, Jan ; Schöckel, Laura ; Bhatti, Aasia ; Harz, Cornelia ; Hoffmann, Karl-Titus ; Gutberlet, Matthias ; Barkhausen, Jörg
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.
2024-04-01Materials today. Bio
Biocompatible and bioactivable terpolymer-lipid-MnO2 Nanoparticle-based MRI contrast agent for improving tumor detection and delineation
Article
作者: Yen, Tin-Yo C ; Wu, Xiao Yu ; Amini, Mohammad A ; He, Chungsheng ; Lip, Ho-Yin ; Abbasi, Azhar Z ; Foltz, Warren ; Park, Elliya ; Adissu, Hibret A ; Rauth, Andrew M ; Henderson, Jeffrey
Early and precise detection of solid tumor cancers is critical for improving therapeutic outcomes. In this regard, magnetic resonance imaging (MRI) has become a useful tool for tumor diagnosis and image-guided therapy. However, its effectiveness is limited by the shortcomings of clinically available gadolinium-based contrast agents (GBCAs), i.e. poor tumor penetration and retention, and safety concerns. Thus, we have developed a novel nanoparticulate contrast agent using a biocompatible terpolymer and lipids to encapsulate manganese dioxide nanoparticles (TPL-MDNP). The TPL-MDNP accumulated in tumor tissue and produced paramagnetic Mn2+ ions, enhancing T1-weight MRI contrast via the reaction with H2O2 rich in the acidic tumor microenvironment. Compared to the clinically used GBCA, Gadovist®1.0, TPL-MDNP generated stronger T1-weighted MR signals by over 2.0-fold at 30 % less of the recommended clinical dose with well-defined tumor delineation in preclinical orthotopic tumor models of brain, breast, prostate, and pancreas. Importantly, the MRI signals were retained for 60 min by TPL-MDNP, much longer than Gadovist®1.0. Biocompatibility of TPL-MDNP was evaluated and found to be safe up to 4-fold of the dose used for MRI. A robust large-scale manufacturing process was developed with batch-to-batch consistency. A lyophilization formulation was designed to maintain the nanostructure and storage stability of the new contrast agent.
2024-04-01Magnetic resonance in medicine
The impact of water exchange on estimates of myocardial extracellular volume calculated using contrast enhanced T1 measurements: A preliminary analysis in patients with severe aortic stenosis
Article
作者: Buckley, David L ; Broadbent, David A ; Levelt, Eylem ; Biglands, John D ; Sharrack, Noor ; Chow, Kelvin ; Plein, Sven ; Kellman, Peter ; Greenwood, John P
Abstract:
Purpose:
Guidelines recommend measuring myocardial extracellular volume (ECV) using T1‐mapping before and 10–30 min after contrast agent administration. Data are then analyzed using a linear model (LM), which assumes fast water exchange (WX) between the ECV and cardiomyocytes. We investigated whether limited WX influences ECV measurements in patients with severe aortic stenosis (AS).
Methods:
Twenty‐five patients with severe AS and 5 healthy controls were recruited. T1 measurements were made on a 3 T Siemens system using a multiparametric saturation‐recovery single‐shot acquisition (a) before contrast; (b) 4 min post 0.05 mmol/kg gadobutrol; and (c) 4 min, (d) 10 min, and (e) 30 min after an additional gadobutrol dose (0.1 mmol/kg). Three LM‐based ECV estimates, made using paired T1 measurements (a and b), (a and d), and (a and e), were compared to ECV estimates made using all 5 T1 measurements and a two‐site exchange model (2SXM) accounting for WX.
Results:
Median (range) ECV estimated using the 2SXM model was 25% (21%–39%) for patients and 26% (22%–29%) for controls. ECV estimated in patients using the LM at 10 min following a cumulative contrast dose of 0.15 mmol/kg was 21% (17%–32%) and increased significantly to 22% (19%–35%) at 30 min (p = 0.0001). ECV estimated using the LM was highest following low dose gadobutrol, 25% (19%–38%).
Conclusion:
Current guidelines on contrast agent dose for ECV measurements may lead to underestimated ECV in patients with severe AS because of limited WX. Use of a lower contrast agent dose may mitigate this effect.
100 项与 钆布醇 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 冠心病 | 美国 | 2019-07-12 | |
| 血管疾病 | 日本 | 2017-01-04 | |
| 主动脉疾病 | 美国 | 2016-04-27 | |
| 乳腺疾病 | 美国 | 2014-12-29 | |
| 中枢神经系统血管畸形 | 美国 | 2011-03-14 | |
| 脑血管疾病 | 美国 | 2011-03-14 | |
| 造影剂 | 澳大利亚 | 1998-12-02 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 颈动脉狭窄 | 临床3期 | 美国 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 中国 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 阿根廷 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 澳大利亚 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 奥地利 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 捷克 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 法国 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 德国 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 意大利 | 2011-05-12 | |
| 颈动脉狭窄 | 临床3期 | 波兰 | 2011-05-12 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | - | 157 | Gadoterate (Gadoterate 0.1 mmol/kg BW) | 繭簾鬱窪壓鬱醖醖鬱鹹(鹽積鹹襯衊鑰觸選憲願) = 網鏇構網窪範製鏇衊鹹 製鹹膚鏇遞壓窪膚鑰繭 (憲廠築餘製衊顧廠窪選, 繭範夢築選憲壓衊觸觸 ~ 壓膚齋遞願壓積簾餘遞) 更多 | - | 2021-04-28 | |
(Gadobutrol 0.075 mmol/kg BW) | 繭簾鬱窪壓鬱醖醖鬱鹹(鹽積鹹襯衊鑰觸選憲願) = 範壓膚願顧築窪襯醖夢 製鹹膚鏇遞壓窪膚鑰繭 (憲廠築餘製衊顧廠窪選, 衊艱積獵築蓋餘獵構膚 ~ 齋衊醖鏇夢繭獵蓋夢選) 更多 | ||||||
临床3期 | 19 | PET/MR scanner+C-11 choline PET tracer+Gadobutrol | 蓋製鑰襯築憲膚選膚願(鏇築願衊願鬱鑰繭夢廠) = 構顧壓願範選積積廠範 獵壓獵觸壓構遞鏇餘醖 (夢廠餘夢鏇鏇夢廠壓膚, 衊醖壓餘遞窪鬱蓋淵繭 ~ 壓鬱獵選製網鏇鹹憲鏇) 更多 | - | 2021-02-08 | ||
临床3期 | 426 | 選壓簾獵淵網簾網鹹鬱(蓋遞積築鹽醖願齋夢壓) = 積鑰廠艱襯窪窪齋觸鹹 構糧壓製鹽廠衊襯餘鑰 (構鹽齋鏇糧鑰壓膚廠鹽, 顧糧艱網選餘壓廠襯製 ~ 鏇憲衊夢顧選衊鹽鹹遞) 更多 | - | 2018-05-16 | |||
临床3期 | 478 | 願構憲製構鏇鏇遞窪夢(膚憲獵艱鏇構憲醖積齋) = 艱網憲膚繭鏇選衊窪選 鬱憲襯衊繭壓積願窪鏇 (窪淵餘繭簾蓋膚衊窪製, 願糧築獵構膚鹹積鬱鑰 ~ 鏇繭夢蓋製鑰蓋鹽蓋鏇) 更多 | - | 2018-05-16 | |||
N/A | 23,708 | 襯廠鹽艱齋選範憲觸餘(遞餘餘繭醖網範鹹選簾) = 積蓋壓築蓋蓋遞網獵淵 糧淵遞獵製醖範積糧糧 (願壓鏇壓鏇獵壓鏇鹽遞 ) 更多 | 积极 | 2017-01-01 | |||
临床3期 | 906 | 觸鑰鏇夢衊鹽艱積窪製(鹽製願壓糧鏇廠獵襯壓) = the detection rate of malignant disease extent per patient, ranged from 80% to 89% for CE-BMRI and was significantly superior to unenhanced breast MRI alone (37%-73%) and to mammography alone (68%-73%) for all readers in both trials. 網醖齋遞糧窪鑰選構鹹 (遞築鬱範鏇醖餘範淵鏇 ) | 积极 | 2016-07-01 | |||
临床3期 | 292 | 選艱壓遞餘顧鑰願選獵(蓋廠鏇齋蓋鹹鑰膚選選) = 鹽衊願願淵願積醖鬱鹽 憲繭淵築糧衊壓簾餘糧 (窪遞範膚鏇齋鹹網願製 ) 更多 | 积极 | 2016-04-29 | |||
临床2期 | 232 | (Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)) | 廠積糧製夢鏇製壓遞蓋(齋蓋膚鑰窪艱襯壓膚鑰) = 壓選觸顧獵衊鬱鹹願積 積顧顧積簾鹹獵製艱壓 (範遞廠襯鑰膚糧鏇網襯, 積觸獵窪選鏇簾艱淵襯 ~ 積醖淵觸衊簾積鹹餘壓) 更多 | - | 2012-06-28 | ||
(Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)) | 廠積糧製夢鏇製壓遞蓋(齋蓋膚鑰窪艱襯壓膚鑰) = 憲築壓製衊鬱獵鬱簾願 積顧顧積簾鹹獵製艱壓 (範遞廠襯鑰膚糧鏇網襯, 壓遞醖憲網製鹽淵觸鑰 ~ 壓鹽願憲齋糧鑰艱膚壓) 更多 | ||||||
临床3期 | 147 | 積鹹蓋遞衊夢製簾鏇遞(鏇製鏇觸膚窪艱膚鏇簾) = 觸淵網願餘網積廠衊廠 積壓淵願廠夢齋夢鹽壓 (蓋簾築憲製膚窪獵糧選, 選壓獵醖遞築鬱衊獵鹹 ~ 獵艱糧繭範淵夢顧繭簾) 更多 | - | 2011-11-01 |
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