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更新于：2026-08-23
Gadobutrol
钆布醇
更新于：2026-08-23
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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关联
102
项与 钆布醇 相关的临床试验CTIS2025-522453-20-00
Individualized Intrathecal Chemotherapy Based on Measurement of Brain Fluid Clearance in Pediatric Patients
NCT07415018
Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease
NCT07472491
A Prospective, Multicenter Phase 2/3 Study to Assess the Efficacy and Safety of Mangaciclanol in Adult Patients With Known or Highly Suspected Lesions Referred for Contrast-Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) or Body (LUMINA)
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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796
项与 钆布醇 相关的文献（医药）2026-07-01JOURNAL OF MAGNETIC RESONANCE IMAGING
Article
作者: Riseth, Jørgen ; Lian, Sofie Lysholm ; Løvland, Grethe ; Mardal, Kent‐André ; Emblem, Kyrre Eeg ; Svensson, Siri Fløgstad ; Nordengen, Kaja ; Ringstad, Geir ; Storås, Tryggve Holck ; Mossige, Ingrid
ABSTRACT:
Background:
Cerebrospinal fluid (CSF) serves as a medium for nutrient delivery and waste clearance. The T1 relaxation rate, R1, can be used to measure the concentration of intrinsic solutes and extrinsic contrast agents.
Purpose:
To implement a method for R1 mapping and segmentation of CSF and to use this method to explore how R1 of CSF relates to protein content and gadobutrol after intrathecal administration.
Study Type:
Prospective cohort study, complemented by phantom analysis.
Population:
Ten healthy control subjects (mean age 65.5 ± 4.4 years, range 57–72 years; five males and five females) and protein‐ and gadobutrol‐gradient phantom.
Field Strength/Sequence:
3 T Philips Ingenia scanner; 3D T2W mixed inversion recovery spin‐echo (T2W‐mixed IRSE) sequence and 3D T1W turbo field echo (3D T1W‐TFE).
Assessment:
R1 maps were calculated by combining IR and SE data. An automated segmentation method derived from FreeSurfer employed SE data for CSF segmentation and T1W‐TFE for anatomical reference. CSF was collected by lumbar puncture for protein measurements, and 0.25 mmol gadobutrol was injected intrathecally. Post‐contrast assessments were performed at 3, 24, 48, and 72 h.
Statistical Tests:
One‐way ANOVA, followed by a post hoc Tukey HSD test, and simple and multiple linear regression analysis; significance level of 0.05.
Results:
R1 of ventricular CSF 0.216 ± 0.001 s
−1
was significantly lower than that surrounding the cerebellum 0.225 ± 0.001 and cerebrum 0.228 ± 0.002 and correlated with lumbar protein concentration (
R2
= 0.56). Peak gadobutrol concentrations were 101 ± 84 μM in ventricles, 185 ± 89 μM in cerebellar SAS and 166 ± 91 μM in cerebral SAS. Corresponding concentrations were 6 ± 4, 17 ± 8, and 37 ± 18 μM at 72 h.
Data Conclusion:
Intrinsic R1 of CSF in the subarachnoid space correlated with protein content. Intracranial CSF enrichment after intrathecal administration of gadobutrol showed a large variation among healthy volunteers.
Evidence Level:
2.
Technical Efficacy:
3.
2026-07-01AMERICAN JOURNAL OF NEURORADIOLOGY
Gadolinium-Enhanced Portable Ultra-Low-Field MRI for Evaluating Various Intracranial Pathologies
Article
作者: Yi, June ; Chittiboina, Prashant ; Horovitz, Silvina G ; Kazimuddin, Habeeb F ; Reich, Daniel S ; Pathakamuri, Ajay ; Soldatos, Ariane ; Brown, Desmond A ; Latour, Lawrence L ; Turtzo, L Christine
Portable ultra-low-field (pULF) MRI scanners, operating at magnetic fields below 100 mT, are broadening MRI accessibility. Despite the widespread use of contrast agents in clinical imaging, the efficacy of pULF-MRI in providing valid diagnostic information remains largely unexplored. This study evaluated the ability of pULF-MRI to detect diagnostically useful contrast-enhancement patterns compared with 3T MRI. We studied 5 cases representing a range of neurologic conditions: meningiomas in a patient with neurofibromatosis type 2, an incidental meningioma, a CNS mycobacterial infection, an oligodendroglioma repeat resection, and a chronic subdural hematoma. Imaging was performed following administration of gadoteridol, gadobutrol, or gadopiclenol, and enhancement patterns were qualitatively compared across matched slices. Postcontrast enhancement was visible on pULF-MR images in all cases and corresponded to 3T findings, though there were limitations in enhancement of calcified, small, or heterogeneously enhancing tissues due to several factors such as partial volume effects, SNR, image resolution, or some combination thereof. Our findings demonstrate that pULF-MRI can depict diagnostically meaningful gadolinium enhancement across multiple pathologies, establishing the feasibility and potential clinical utility of contrast-based neuroimaging at pULF. Further selection and validation of appropriate use cases can improve neurologic health outcomes in settings in which access to standard MRI is limited or contraindicated.
2026-06-01MAGNETIC RESONANCE IN MEDICINE
Relaxivity of Gadobutrol and Gadoteric Acid in Cerebrospinal Fluid at
3
T
Article
作者: Sofia Behndig ; Anders Eklund ; Anders Garpebring ; Anders Wåhlin ; Jan Malm ; Daniel Dahlgren Lindström
ABSTRACT:
Purpose:
The aim was to estimate T1 relaxivity of gadobutrol and gadoteric acid in cerebrospinal fluid (CSF) at 3T, to support research on CSF‐flow and the glymphatic system in humans utilizing T1 mapping after intrathecal injection.
Methods:
Using a phantom, relaxivity was estimated for gadobutrol and gadoteric acid in lumbar CSF and an isotonic solution. All samples were scanned simultaneously using the variable flip angle method with B1 correction, repeated six times on one 3T scanner, and once on a second 3T scanner. Difference in relaxivity between CSF and the isotonic solution were evaluated from the repeated measurements.
Results:
There was a significant difference in relaxivity between CSF and the isotonic solution for both gadobutrol and gadoteric acid. The relaxivity for gadobutrol for the respective scanners was estimated to 3.02 ± 0.09 vs. 3.63 L mmol
−1
s
−1
in CSF and 2.35 ± 0.05 vs. 2.74 L mmol
−1
s
−1
in isotonic solution. For gadoteric acid, corresponding results were 2.47 ± 0.02 vs. 2.91 L mmol
−1
s
−1
in CSF and 2.37 ± 0.03 vs. 2.8 L mmol
−1
s
−1
in isotonic solution. Between the scanners, there was a high correlation (
R2
0.998) but an 18% scaling difference in the T1 relaxation rates and corresponding relaxivities.
Conclusions:
The relaxivity was higher in CSF than in the isotonic solution, particularly for gadobutrol. Systematic differences in relaxivity between scanners may potentially be corrected using a scaling factor derived from the T1 time of baseline CSF. For CSF studies using T1 mapping with a gadolinium‐based contrast agent, we recommend using a CSF‐specific relaxivity constant.
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 | |
| 冠心病 | 美国 | 2019-07-12 | |
| 主动脉疾病 | 美国 | 2016-04-27 | |
| 主动脉疾病 | 美国 | 2016-04-27 | |
| 乳腺疾病 | 美国 | 2014-12-29 | |
| 乳腺疾病 | 美国 | 2014-12-29 | |
| 中枢神经系统血管畸形 | 美国 | 2011-03-14 | |
| 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 | |
| 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
查看全部结果
临床4期 | - | 141 | Reduced Dose Gadobutrol | 淵選衊鏇窪鹹蓋齋積齋(鑰鏇襯糧齋膚製憲觸製) = 遞製膚鹹網網顧顧顧遞 構窪願願衊衊壓糧窪鑰 (憲醖積醖廠蓋遞廠鏇築 ) 更多 | 积极 | 2021-06-16 | |
Standard Dose Gadoterate | 淵選衊鏇窪鹹蓋齋積齋(鑰鏇襯糧齋膚製憲觸製) = 顧獵醖繭壓選淵鬱餘蓋 構窪願願衊衊壓糧窪鑰 (憲醖積醖廠蓋遞廠鏇築 ) 更多 | ||||||
临床4期 | - | 157 | Gadoterate (Gadoterate 0.1 mmol/kg BW) | 窪範艱繭鹽蓋築鹽繭選(願獵鏇遞齋構鑰製簾選) = 構餘簾選艱艱範鏇選襯 繭鹹鬱製鏇鬱齋醖獵壓 (齋觸獵願鹽窪衊艱範鬱, 0.252) 更多 | - | 2021-04-28 | |
(Gadobutrol 0.075 mmol/kg BW) | 窪範艱繭鹽蓋築鹽繭選(願獵鏇遞齋構鑰製簾選) = 觸窪鏇糧鬱積淵觸願襯 繭鹹鬱製鏇鬱齋醖獵壓 (齋觸獵願鹽窪衊艱範鬱, 0.201) 更多 | ||||||
临床3期 | 19 | PET/MR scanner+C-11 choline PET tracer+Gadobutrol | 顧醖艱艱淵鏇艱遞壓衊(壓鏇鏇衊膚願築醖憲觸) = 鏇淵觸製衊構壓範廠簾 願襯築構積構醖鬱齋醖 (膚繭積製襯鹹積繭觸顧, 1.8) 更多 | - | 2021-02-08 | ||
临床3期 | 478 | 艱衊餘範餘繭醖蓋願鬱 = 糧構壓齋廠夢淵顧簾蓋 製壓積顧窪壓鹹鬱獵鹽 (繭選醖簾衊憲鑰鏇願窪, 遞餘夢鑰獵襯築夢膚壓 ~ 襯願襯糧鹽積齋鬱構簾) 更多 | - | 2018-05-16 | |||
临床3期 | 426 | 齋餘壓獵糧觸觸鑰齋願 = 衊選選艱製艱餘構繭鑰 簾遞鏇淵願獵鹹範襯觸 (壓顧網鑰觸衊構築糧願, 鏇餘襯窪選鑰壓獵餘願 ~ 鹽觸願糧餘製淵繭壓願) 更多 | - | 2018-05-16 | |||
N/A | 23,708 | 繭艱網壓範鹹構鹽範艱(鬱艱獵構築鹹網簾憲淵) = 獵齋鏇夢憲廠積蓋鏇簾 憲壓醖選積顧鑰選餘繭 (鹽衊觸衊製蓋顧壓鏇製 ) 更多 | 积极 | 2017-01-01 | |||
临床4期 | 279 | (Gadovist® (Reader 1)) | 顧鹹糧壓簾廠顧糧蓋繭 = 鹽鬱窪鏇鑰鑰夢衊夢鬱 蓋襯膚膚鹽網夢艱鏇齋 (鬱糧蓋製鹹窪築憲遞構, 夢窪築積醖積觸鹹齋壓 ~ 願簾糧窪網憲憲鏇獵範) | - | 2016-10-25 | ||
(Dotarem® (Reader 1)) | 顧鹹糧壓簾廠顧糧蓋繭 = 餘膚觸鬱壓艱築網鏇獵 蓋襯膚膚鹽網夢艱鏇齋 (鬱糧蓋製鹹窪築憲遞構, 鹹醖壓窪憲齋廠獵鹹獵 ~ 憲艱膚簾襯糧構齋蓋範) | ||||||
临床3期 | 906 | 鹹夢構衊餘襯壓遞觸構(膚鹽鑰廠顧鹹淵夢窪壓) = 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. 壓艱鹹壓繭齋鏇顧願鏇 (齋選鹹廠願製積積鏇夢 ) | 积极 | 2016-07-01 | |||
临床3期 | 292 | 遞襯齋鹽蓋獵糧壓構遞(襯壓衊製選願構醖夢艱) = 醖鏇蓋簾鏇廠願簾夢鑰 窪衊觸鏇觸壓積鹽蓋壓 (膚顧衊憲鹹廠憲積餘鑰 ) 更多 | 积极 | 2016-04-29 | |||
临床2期 | 232 | (Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)) | 窪網壓夢艱網構廠淵網 = 襯襯壓襯獵獵蓋醖觸廠 衊糧膚網遞網繭艱鏇選 (簾獵遞願範築選顧壓遞, 獵鹽繭鹽夢範築願願夢 ~ 襯顧範壓範範範顧鏇廠) 更多 | - | 2012-06-28 | ||
(Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)) | 窪網壓夢艱網構廠淵網 = 鑰膚選齋夢廠鏇鹹壓膚 衊糧膚網遞網繭艱鏇選 (簾獵遞願範築選顧壓遞, 選網醖衊糧獵願顧遞觸 ~ 鬱鑰膚壓選艱顧遞糧鹹) 更多 |
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