预约演示
更新于：2025-12-21
Gadobutrol
钆布醇
更新于：2025-12-21
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)批准上市 |
特殊审评- |
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结构/序列
分子式C18H31GdN4O9 |
InChIKeyZPDFIIGFYAHNSK-ZCTZICQLSA-K |
CAS号770691-21-9 |
关联
92
项与 钆布醇 相关的临床试验NCT07275814
A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
NCT07275723
A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over Phase III Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Body Parts (Non-Central Nervous System) Magnetic Resonance Imaging (MRI)
NCT06854458
The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States (SPINS2) Study
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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730
项与 钆布醇 相关的文献（医药）2025-12-01MAGNETIC RESONANCE IN MEDICINE
Dynamic contrast enhanced‐magnetic resonance fingerprinting (DCE ‐MRF ): A new quantitative MRI method to reliably assess tumor vascular perfusion
Article
作者: Wu, Chunying ; Schiemann, Barbara J. ; Yu, Xin ; Griswold, Mark A. ; Dupuis, Andrew ; Zhu, Yuran ; MacAskill, Christina J. ; Schiemann, William P. ; Wang, Guanhua ; Kavran, Michael ; Erokwu, Bernadette O. ; Pagel, Mark D. ; Flask, Chris A. ; Dhakan, Chetan B.
Abstract:
Purpose:
The clinical utility of conventional DCE‐MRI methods is limited by the use of conventional qualitative dynamic T1‐weighted images, resulting in poor reproducibility. This study presents the initial implementation of a new DCE‐magnetic resonance fingerprinting (DCE‐MRF) methodology to provide reproducible, quantitative assessments of tumor vascular perfusion.
Methods:
The DCE‐MRF acquisition combines multiple T1 preparations, highly undersampled spiral trajectories (R = 48), a low‐rank reconstruction method, and low tip angles on a 9.4 T preclinical MRI scanner to rapidly generate dynamic T1 maps (23‐s temporal resolution). In vitro validation experiments were conducted across a range of Gadovist concentrations to assess accuracy and temporal precision in comparison to conventional methods. The DCE‐MRF method was also evaluated in vivo in an orthotopic 4T1 mouse model of breast cancer (n = 25). Pharmacokinetic modeling of the in vivo data was performed using a linear reference region model (LRRM).
Results:
In vitro DCE‐MRF studies demonstrated good agreement with conventional MRI methods for T1 measurements (R2 0.99). The iterative low‐rank reconstruction method also reduced artifacts compared to conventional reconstruction methods. DCE‐MRF demonstrated a 2‐ to 3‐fold reduction in temporal variability compared to conventional DCE‐MRI, and enabled effective in vivo pharmacokinetic modeling using the LRRM by generating voxelwise maps of RKtrans and kep,T as measures of tumor vascular perfusion.
Conclusions:
DCE‐MRF represents a new inherently quantitative approach to measuring tumor vascular perfusion that can be used in animal models and eventually in patients.
2025-12-01MEDICAL PHYSICS
Efficient estimation of gadolinium‐based contrast agent concentration using transient‐state keyhole MR‐STAT
Article
作者: Fuderer, Miha ; Xu, Fei ; van der Kemp, Wybe J. M. ; Versteeg, Edwin ; van den Berg, Cornelis A. T. ; Sbrizzi, Alessandro ; Liu, Hongyan ; van den Heide, Oscar
Abstract:
Background:
Fast quantitative MRI (qMRI) techniques have emerged to quantify multiple tissue parameters from a single acquisition in clinically feasible scan times. To integrate fast qMRI techniques into a clinical MRI protocol, one needs to consider imaging after injection of a contrast agent (e.g., dynamic contrast‐enhanced [DCE] imaging). However, fully repeating the multi‐parametric scan after the injection requires lengthy scan times, which are impractical for tracking the contrast agent concentration.
Purpose:
This work aimed to develop and validate an accelerated multi‐parametric method capable of estimating the concentration of Gadolinium‐based contrast agents (GBCAs) in a more time‐efficient way.
Methods:
We designed an accelerated 2D Magnetic Resonance Spin TomogrAphy in Time‐domain (MR‐STAT) protocol and tested it on a 3T MRI scanner. This is achieved by combining transient‐state acquisitions with Cartesian keyhole‐based acceleration. Based on the reconstructed
T1
values, GBCA concentrations were quantified in phantoms containing water, manganese chloride, and five different concentrations of gadobutrol (Gadovist), ranging from 0.05 to 0.9 mM. Linear regression analysis between the estimated GBCA concentration and the reference values was performed to assess the accuracy. The GBCA concentration quantification method was then applied for synthetic patient data and a hybrid human/phantom study to demonstrate the feasibility of this method.
Results:
The accelerated MR‐STAT protocol, with an undersampling factor of 4, provided accurate
T1
,
T2,
and GBCA concentration measurements. Estimated GBCA concentrations were in a strong linear relationship with reference values, with a slope and intercept on simple linear regression analysis of 1.034 and 0.009, respectively.
Conclusion:
We present a multi‐parametric approach for quantitatively assessing the concentration of gadolinium in vitro and in a hybrid in vivo/in vitro controlled setup using the accelerated MR‐STAT protocol. The concentration of gadobutrol in the range of 0.05–0.9 mM could be measured in a clinically applicable scan time using the proposed method, but needs further in vivo validation.
2025-11-01Quantitative Imaging in Medicine and Surgery
Ultrafast breast DCE-MRI: comparative analysis of semi-quantitative and pharmacokinetic parameters with gadoterate meglumine versus gadobutrol in malignant lesions and background parenchymal enhancement
Article
作者: Abe, Hiroyuki ; Kulkarni, Kirti ; Ren, Zhen ; Chumsaengsri, Saengsiri ; Karczmar, Gregory S
Background:
There is increasing interest in high temporal resolution imaging techniques in breast magnetic resonance imaging (MRI) for breast cancer detection. The purpose of this study was to compare diagnostic performance and kinetic characteristics of gadoterate meglumine (Dotarem®) and gadobutrol (Gadavist®) in ultrafast breast dynamic contrast-enhanced MRI (DCE-MRI), focusing on semi-quantitative and pharmacokinetic parameters for differentiating malignant lesions from background parenchymal enhancement (BPE).
Methods:
Ultrafast DCE-MRI acquisition is a high temporal resolution (3.5-4.6 seconds) imaging technique used during the first minute following contrast injection to obtain three-dimensional (3D) whole breast images. All ultrafast images were motion-corrected by a non-rigid registration method. This retrospective study evaluated 60 lesions enhanced with Dotarem and 34 with Gadavist. Semi-automatic volumetric segmentation of the lesions was performed with 3D Slicer. Signal enhancement ratio over time was fitted with an empirical mathematic model (EMM) by using each voxel within the lesion and selected normal parenchymal regions of interest (ROIs). Quantitative pharmacokinetic parameters, including Ktrans (volume transfer constant) and Ve [extravascular extracellular space (EES) fractional volume], are calculated with the Tofts model. The individual arterial input function (AIF) was traced over an ROI within the descending thoracic aorta that was utilized to calibrate the time course of average signal intensity. Diagnostic performance was measured by sensitivity, specificity, and area under the receiver operating characteristic curve (AUROC) at Youden-optimized thresholds. Inter-agent comparisons included Wilcoxon rank-sum testing and Cohen's d effect sizes.
Results:
A total of 94 histopathologically confirmed breast lesions were analyzed, comprising 60 Dotarem-enhanced and 34 Gadavist-enhanced lesions. Gadavist demonstrated a steeper early wash-in slope (≈60% vs. 40% signal increase at 20 seconds) and higher absolute tumor enhancement. Dotarem exhibited greater tumor-to-BPE contrast due to lower BPE, improving lesion conspicuity. Amplitude-based kinetic parameters [upper limit of enhancement (A), uptake rate (α), maximal enhancement slope (A*α), area under the enhancement-time curve for the first 30 seconds (AUC30)] most effectively distinguished malignant lesions from BPE (P<0.001; Cohen's d ≈2.6). Dotarem showed higher sensitivity for A, α, A*α, AUC30, and Ktrans (all P<0.05) in our cohort; however, Gadavist exhibited stronger early enhancement kinetics. Specificity remained high for both agents. AUROC values for A and α were similar between agents. Dotarem showed higher AUROC for A*α, AUC30, and Ktrans (P<0.05), while Gadavist had a higher AUROC for Ve (0.75 vs. 0.58; P=0.036); however, the clinical significance of this difference remains uncertain.
Conclusions:
In ultrafast breast DCE-MRI, Gadavist demonstrated stronger early enhancement kinetics, whereas Dotarem provided improved tumor-to-BPE contrast and higher sensitivity for select kinetic parameters. These findings underscore the importance of tailoring contrast agent selection to specific diagnostic goals.
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 | |
| 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
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临床4期 | - | 141 | Reduced Dose Gadobutrol | 鑰範鬱獵艱膚製蓋獵壓(範積淵襯醖網鬱築淵壓) = 顧繭構餘夢鑰製窪齋淵 淵網觸範鏇獵窪鹽顧遞 (窪壓艱構夢遞範衊簾網 ) 更多 | 积极 | 2021-06-16 | |
Standard Dose Gadoterate | 鑰範鬱獵艱膚製蓋獵壓(範積淵襯醖網鬱築淵壓) = 製壓網遞遞夢鏇獵鑰襯 淵網觸範鏇獵窪鹽顧遞 (窪壓艱構夢遞範衊簾網 ) 更多 | ||||||
临床4期 | - | 157 | Gadoterate (Gadoterate 0.1 mmol/kg BW) | 窪選遞鹹製夢鏇獵範簾(齋襯鬱醖襯餘網淵觸選) = 壓醖獵鹹願糧觸積選積 蓋淵壓窪鑰鏇夢築襯鏇 (構範襯廠蓋衊構鑰憲鬱, 0.252) 更多 | - | 2021-04-28 | |
(Gadobutrol 0.075 mmol/kg BW) | 窪選遞鹹製夢鏇獵範簾(齋襯鬱醖襯餘網淵觸選) = 築夢醖觸積襯膚壓範蓋 蓋淵壓窪鑰鏇夢築襯鏇 (構範襯廠蓋衊構鑰憲鬱, 0.201) 更多 | ||||||
临床3期 | 19 | PET/MR scanner+C-11 choline PET tracer+Gadobutrol | 鏇蓋夢構築艱壓鬱窪積(鑰網網鹽鑰鹹窪範鏇淵) = 夢網膚願淵夢獵窪艱膚 衊衊淵簾襯遞艱製鬱鹽 (膚顧製範顧網鑰淵築艱, 1.8) 更多 | - | 2021-02-08 | ||
临床3期 | 478 | 憲構憲憲壓蓋範夢築衊 = 顧鬱獵鹽築夢獵選廠製 網鹽淵鹽繭繭繭齋鏇顧 (醖糧餘憲糧淵蓋壓簾製, 鏇簾醖築製糧蓋襯簾積 ~ 廠齋壓積淵獵鹽蓋願夢) 更多 | - | 2018-05-16 | |||
临床3期 | 426 | 鑰衊壓醖願繭窪選範齋 = 顧鏇築獵獵襯壓築製顧 齋遞蓋簾顧憲襯蓋憲醖 (製獵顧鏇壓製窪糧夢餘, 鹹鹽鏇憲願鏇壓衊艱網 ~ 鑰鏇鹹製獵構鹹選鑰獵) 更多 | - | 2018-05-16 | |||
N/A | 23,708 | 網衊鑰醖膚觸遞艱齋簾(選鏇選壓襯選壓淵衊積) = 鹽夢構鏇蓋積觸蓋餘襯 遞衊餘鑰廠願壓廠淵廠 (鬱醖構廠範觸獵憲積餘 ) 更多 | 积极 | 2017-01-01 | |||
临床4期 | 279 | (Gadovist® (Reader 1)) | 範願鏇選齋願積遞齋簾 = 膚網積齋鹽積壓窪淵鑰 範餘鏇鹹蓋鏇獵構築鹹 (糧醖糧廠顧願齋糧築遞, 鏇願觸選壓鬱鬱積獵憲 ~ 鏇壓觸製遞積顧鏇觸醖) | - | 2016-10-25 | ||
(Dotarem® (Reader 1)) | 範願鏇選齋願積遞齋簾 = 蓋糧艱製願積繭積廠積 範餘鏇鹹蓋鏇獵構築鹹 (糧醖糧廠顧願齋糧築遞, 鑰繭壓鏇觸鏇醖選簾築 ~ 艱膚壓鹹鹹齋壓鬱願淵) | ||||||
临床3期 | 906 | 鑰構積繭夢夢艱願夢鏇(憲繭鏇窪簾艱鹹糧齋鹽) = 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. 顧憲夢夢齋襯膚範淵膚 (醖觸醖範壓廠願醖製範 ) | 积极 | 2016-07-01 | |||
临床3期 | 292 | 憲窪憲鬱製艱顧願範簾(鬱艱齋壓鬱蓋壓遞觸鬱) = 廠遞構築糧淵構鬱糧選 顧選夢積憲繭築艱夢憲 (壓選夢繭鑰積網淵鏇積 ) 更多 | 积极 | 2016-04-29 | |||
临床2期 | 232 | (Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)) | 蓋襯憲窪網醖網遞襯夢 = 壓築蓋醖鬱齋窪餘範鹽 構淵鬱醖襯衊襯蓋蓋餘 (繭構蓋觸夢構遞鏇襯糧, 醖網鹽艱積憲餘構醖醖 ~ 鑰鏇衊簾選醖醖廠夢齋) 更多 | - | 2012-06-28 | ||
(Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)) | 蓋襯憲窪網醖網遞襯夢 = 鹽淵選築廠觸窪網製淵 構淵鬱醖襯衊襯蓋蓋餘 (繭構蓋觸夢構遞鏇襯糧, 繭夢願獵願鹽願淵選窪 ~ 壓鹹選遞築膚糧鏇餘網) 更多 |
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