预约演示
更新于：2026-05-07
Florbetaben F-18
氟[¹⁸F]贝他苯
更新于：2026-05-07
概要
基本信息
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、快速通道 (美国) |
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结构/序列
分子式C21H26FNO3 |
InChIKeyNCWZOASIUQVOFA-FWZJPQCDSA-N |
CAS号902143-01-5 |
关联
47
项与 氟[¹⁸F]贝他苯 相关的临床试验NCT07169630
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer s Disease (AD) or Mild Cognitive Impairment (MCI)
ACTRN12626000208303
Finding the fibril in the haystack: A pilot study of Amyloid ([18F] Florbetaben) PET-CT in Peripheral Nerve Amyloidosis
CTIS2023-503705-10-00
Patient- and care-related benefits of amyloid PET imaging (ENABLE)
100 项与 氟[¹⁸F]贝他苯 相关的临床结果
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100 项与 氟[¹⁸F]贝他苯 相关的转化医学
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100 项与 氟[¹⁸F]贝他苯 相关的专利（医药）
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192
项与 氟[¹⁸F]贝他苯 相关的文献（医药）2026-05-01JPAD-Journal of Prevention of Alzheimers Disease
Discordance in amyloid positivity between visual reads and Centiloids: Impact of white matter uptake
Article
作者: Devanarayan, Viswanath ; Charil, Arnaud ; Reyderman, Larisa ; Kramer, Lynn D ; Irizarry, Michael C ; Reilhac, Anthonin ; Dhadda, Shobha ; Nelson, Todd M
BACKGROUND:
The visual interpretation of amyloid PET scans, or visual read (VR), is the most common technique used in clinical practice to identify the presence of cerebral amyloid plaques. Amyloid status (positive or negative) determined by VR or using a Centiloid (CL) cut-off shows high overall concordance. However, discordant cases can occur where the VR is positive, but the CL is below the positivity cut-off, or vice versa.
OBJECTIVES:
The objective of this analysis was to evaluate the rate of discordance and explore potential causes, particularly the role of amyloid tracer uptake in the white matter (WM), when determining amyloid status using VR and CL in screening for the elenbecestat phase 3 studies in early Alzheimer's disease (AD).
DESIGN:
Amyloid PET scans using either Florbetapir (Amyvid™), Florbetaben (Neuraceq™) or Flutemetamol (Vizamyl™) from 3,232 participants (1507 VR- and 1725 VR+) with cognitive impairment screened for the elenbecestat phase 3 studies in early AD were visually interpreted at screening by trained neuroradiologists and quantified using CL values.
SETTING:
Academic and clinical centers INTERVENTION/MEASUREMENTS: Quantitatively, amyloid positivity was defined as CL > 32.21. The number of positive cortical regions was determined by counting the number of regions with a standardized uptake value ratio (SUVr) that exceeded 1.17. PET SUVr levels in the cerebral WM were measured using an eroded WM region of interest (ROI). Statistical tests were conducted to detect differences among the four concordance groups, defined by the relationship of VR and CL status (positive or negative). Additionally, tests examined the relationship between uptake in the WM and rates and type of discordance. Receiver operating characteristic (ROC) analysis and DeLong's test were also used to examine the effect of different tracers on the discordant rates.
RESULT:
Discordance was observed in 6.53% of cases (n=211), with VR+/CL- in 4.61% (n=149) and VR-/CL+ in 1.92% (n=62). VR+/CL- discordant cases had significantly fewer amyloid-positive cortical regions compared to both VR+/CL+ and VR-/CL+ cases. VR-/CL+ cases had a significantly higher WM uptake than VR-/CL- and VR+/CL- cases. Our findings revealed a relationship between WM uptake and rates and types of discordance. High WM uptake can erroneously lead to CL+, due to gray matter (GM) contamination from the WM, and VR- status, due to reduced contrast between WM and GM, resulting in VR-/CL+ cases. Conversely, low WM uptake can result in an underestimation of CL values, inaccurately classifying a scan as CL-, and at the same time, the increased contrast may result in a VR+, thereby increasing the occurrence of discordant VR+/CL- cases.
CONCLUSION:
Variations in WM uptake significantly contribute to discordances by introducing positive or negative bias in CL values and altering the GM to WM contrast, which forms the basis of the VR. Nevertheless, the rates of discordant cases are low and VR represents a robust and validated method to determine the presence of amyloid deposition. VR enables enrolling patients with amyloid beta pathology, as seen on amyloid PET scans, whereas CL scaling was developed to provide standardized units that more consistently characterize longitudinal amyloid‑β change. These findings reflect the complementary roles of VR and CL in amyloid PET evaluation, with implications for refining diagnostic accuracy and disease monitoring in AD clinical trials and practice.
2026-03-01Journal of Nuclear Medicine Technology
Quantitative Amyloid Brain Imaging: A Literature Review of the Centiloid Scale in Alzheimer Disease Evaluation
Review
作者: York, Benjamin ; Doroudinia, Abtin ; Colletti, Patrick M
Amyloid PET has become a pivotal imaging biomarker for Alzheimer disease (AD), enabling in vivo detection and quantification of β-amyloid deposition. However, variability in quantitative measurements across tracers, scanners, and analysis methods has considerably limited direct comparison of amyloid burden between studies and centers. To address this issue, the Centiloid Project has been developed to provide a standardized quantitative scale for amyloid PET, harmonizing results across tracers and institutions. In this literature review, we aim to summarize current evidence on the development, validation, and clinical application of the Centiloid scale in amyloid PET imaging, emphasizing its methodologic foundations, tracer-specific conversions, and diagnostic thresholds. Methods: A literature review was conducted using PubMed, Scopus, and Embase databases from January 2015 through October 2025. Search terms included "amyloid PET," "Centiloid," "SUVR," and "Alzheimer disease." We reviewed articles with quantitative amyloid PET analyses and Centiloid conversion and studies which compared multiple tracers using MIMneuro software Centiloid calibration. Results: The Centiloid method demonstrates strong intertracer and interscanner harmonization when standardized to the 11C-Pittsburgh compound B reference, with high correlation (r 2 > 0.9) across 18F-labeled tracers, including florbetapir, flutemetamol, and florbetaben. Most articles identified a Centiloid threshold between 20 and 25 Centiloids as indicative of significant amyloid pathology. Implementation of the Centiloid framework improved comparability across clinical trials and longitudinal studies, facilitating integration into the AT(N) research framework. Conclusion: The Centiloid scale represents a critical advancement in quantitative amyloid PET imaging, providing a universal reference that enhances data reproducibility, cross-trial comparisons, and clinical decision-making. Continued work is needed to expand standardization for novel tracers and hybrid imaging systems, ensuring full clinical translation of this metric in dementia imaging.
2025-12-01Alzheimers & Dementia
Longitudinal multicenter head‐to‐head harmonization of tau‐PET tracers
Article
作者: Masdeu, Joseph C. ; Rosa‐Neto, Pedro ; Pascoal, Tharick A ; Gordon, Brian A. ; Bauer‐Negrini, Guilherme ; Fortea, Juan ; Tudorascu, Dana L ; Ferreira, Pamela C.L. ; Lowe, Val J ; Karikari, Thomas K ; Baker, Suzanne L. ; soleimani‐Meigooni, David N. ; Cehula, Juli ; Povala, Guilherme ; Pascual, Belen ; Oh, Hwamee ; Bellaver, Bruna ; Lussier, Firoza Z ; Amaral, Livia
Abstract:
Background:
Standardizing tau pathology quantification in vivo is challenged by inherent characteristics of tau‐PET tracers. The HEAD study aims to generate a leading, longitudinal head‐to‐head dataset of MK‐6240, Flortaucipir, RO948, and PI‐2620 tau‐PET to harmonize tracers' outcomes and develop tools to generalize findings across studies and trials. Here, we provide an update on the progression of the HEAD study.
Method:
HEAD is a multicentric study comprising nine performance sites. Recruitment aimed for 620 individuals between 18‐28 or 50‐90 years, classified as Young/CU/MCI/Dementia. The HEAD protocol involves clinical assessment utilizing the NACC Uniform Data Set, blood collection for banking of plasma/serum/buffy coat/whole blood, and MRI acquisition based on ADNI4. All participants undergo amyloid‐PET with either PiB/NAV4694/Florbetaben/Flutemetamol. All undergo head‐to‐head tau‐PET with at least two tracers, including MK‐6240 (90‐110), Flortaucipir (80‐100), PI‐2620 (45‐75), and RO948 (70‐90). PET data is reconstructed and processed uniformly similarly to ADNI4. The Laboratory of Neuroimaging (LONI) provides centralized databasing, and the National Centralized Repository for ADRD (NCRAD) provides the blood biorepository for all samples. All study procedures are repeated at 18 months.
Result:
Over 26 months,
N
= 679 participants were enrolled into HEAD, exceeding our proposed enrollment by 9.5%. Mean age of older adults is 72.1 years, female distribution is 54%, and 24% of individuals are from underrepresented groups (race/ethnicity/rurality). Progression in data collection has led to
N
= 551 (81%) of enrolled participants having a completed initial timepoint, and 1,489 total acquired head‐to‐head tau‐PET scans (mean acquisition window=34.9 days). Clinical characteristics including group distribution, APOEε4 carriership, plasma biomarker distribution (Aβ42/40 ratio/NfL/GFAP/PTau217), consensus visual rating of amyloid‐PET, and Braak stage classification are summarized in Figure 1. Two representative cases (CU/AD) of head‐to‐head tau‐PET with four tau tracers are shown in Figure 2. Longitudinal data collection has been initiated in
N
= 95 participants. Figure 3. demonstrates two cases (CU/MCI) of 18‐month longitudinal head‐to‐head tau‐PET with MK‐6240 and Flortaucipir.
Conclusion:
The HEAD study cohort represents a continued effort in the optimization of AD imaging biomarkers. Cross‐sectional and longitudinal data collection in HEAD are ongoing, in addition to comprehensive plasma biomarker measurements. Generation of findings from HEAD cohort data will provide novel and crucial guidance on the use of tau‐PET tracers.
100 项与 氟[¹⁸F]贝他苯 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 |
|---|---|---|---|
| 阿尔茨海默症 | 美国 | 2014-03-19 | |
| 认知功能障碍 | 欧盟 | 2014-02-20 | |
| 认知功能障碍 | 冰岛 | 2014-02-20 | |
| 认知功能障碍 | 列支敦士登 | 2014-02-20 | |
| 认知功能障碍 | 挪威 | 2014-02-20 | |
| 诊断试剂 | 欧盟 | 2014-02-20 | |
| 诊断试剂 | 冰岛 | 2014-02-20 | |
| 诊断试剂 | 列支敦士登 | 2014-02-20 | |
| 诊断试剂 | 挪威 | 2014-02-20 |
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 |
|---|---|---|---|---|
| 免疫球蛋白轻链淀粉样变性 | 临床3期 | 美国 | 2023-01-13 | |
| 免疫球蛋白轻链淀粉样变性 | 临床3期 | 德国 | 2023-01-13 | |
| 免疫球蛋白轻链淀粉样变性 | 临床3期 | 西班牙 | 2023-01-13 | |
| 免疫球蛋白轻链淀粉样变性 | 临床3期 | 英国 | 2023-01-13 | |
| 老年性心脏淀粉样变性 | 临床3期 | 美国 | 2023-01-13 | |
| 老年性心脏淀粉样变性 | 临床3期 | 德国 | 2023-01-13 | |
| 老年性心脏淀粉样变性 | 临床3期 | 西班牙 | 2023-01-13 | |
| 老年性心脏淀粉样变性 | 临床3期 | 英国 | 2023-01-13 | |
| 转甲状腺素蛋白淀粉样变性心肌病 | 临床3期 | 美国 | 2023-01-13 | |
| 转甲状腺素蛋白淀粉样变性心肌病 | 临床3期 | 德国 | 2023-01-13 |
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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1期 | 145 | 築範淵願遞積製醖壓選(遞膚繭願鹹構壓膚範鹹) = 願鹽鬱鹹網選觸夢願觸 糧襯積鏇網鏇獵鑰艱醖 (膚齋糧範鏇壓襯廠齋獵, 0.23) 更多 | - | 2025-08-01 | |||
临床2期 | 60 | 11C-PBR28+18F-Florbetaben (Amyloid-positive With Cognitive Impairment (AD)) | 餘獵窪願窪鏇蓋廠製蓋(簾淵鑰積窪積糧蓋觸蓋) = 顧網築簾繭遞築觸鹽製 壓簾選製製糧積遞製廠 (衊蓋網鏇衊憲壓廠鹹餘, 0.18) 更多 | - | 2025-03-05 | ||
11C-PBR28+18F-Florbetaben (Amyloid-positive Without Impairment (Preclinical AD)) | 餘獵窪願窪鏇蓋廠製蓋(簾淵鑰積窪積糧蓋觸蓋) = 製顧襯夢鑰鹹選積鑰範 壓簾選製製糧積遞製廠 (衊蓋網鏇衊憲壓廠鹹餘, 0.16) 更多 | ||||||
N/A | 161 | 蓋獵範鑰網糧築艱糧淵 = 鏇築齋顧顧觸鹽製艱繭 餘壓蓋艱願餘憲鹽衊顧 (艱壓衊壓鑰蓋鏇艱鏇鏇, 窪鏇襯網夢糧鹹醖網鹹 ~ 衊襯鏇廠鹽齋鏇鏇衊選) 更多 | - | 2024-05-06 | |||
临床1/2期 | 9 | (Cognitive Impairment) | 鏇顧積膚製繭遞鑰膚夢(鬱鬱衊範壓廠淵衊繭觸) = 獵壓蓋遞憲艱窪獵廠齋 艱鹹遞鹽衊襯夢構憲糧 (築憲鑰夢鏇憲餘遞襯範, 鏇糧鑰鹽鏇壓繭範鹽窪 ~ 遞簾選鹹簾襯壓構鹽襯) 更多 | - | 2023-09-13 | ||
(No Cognitive Impairment) | 鏇顧積膚製繭遞鑰膚夢(鬱鬱衊範壓廠淵衊繭觸) = 築鑰鹹醖簾窪廠醖膚鏇 艱鹹遞鹽衊襯夢構憲糧 (築憲鑰夢鏇憲餘遞襯範, 範繭憲網齋糧齋淵顧衊 ~ 鑰廠壓衊壓積願顧壓廠) 更多 | ||||||
临床4期 | 218 | 鏇膚製願構淵鑰網鬱壓 = 範廠觸選窪製製鹹窪鏇 願鹽鑰夢蓋齋鑰壓積衊 (範築窪願獵艱鏇衊淵壓, 築築膚鬱夢繭壓醖衊淵 ~ 憲築窪鑰憲鏇鬱範夢壓) 更多 | - | 2018-11-02 | |||
临床4期 | 205 | 築範襯築醖簾醖繭顧簾(糧壓鬱繭窪繭鹽淵繭鑰) = 簾鹹壓繭網觸襯網簾構 鹹鏇艱糧選壓膚衊顧鹽 (顧積網壓艱繭壓築衊蓋, 59.9 ~ 73.2) 更多 | - | 2017-07-01 | |||
临床3期 | 82 | (In-person-trained interpreters) | 壓築襯襯餘醖憲廠餘衊(壓簾淵築艱艱蓋築蓋淵) = 繭觸窪繭廠鏇齋糧鏇膚 築廠鏇網構衊範網範積 (蓋衊製鑰憲顧鹹構窪遞 ) 更多 | - | 2016-06-01 | ||
(Electronic training method) | 壓築襯襯餘醖憲廠餘衊(壓簾淵築艱艱蓋築蓋淵) = 餘鹽蓋鹽蓋襯齋齋鏇鏇 築廠鏇網構衊範網範積 (蓋衊製鑰憲顧鹹構窪遞 ) 更多 | ||||||
临床3期 | 阿尔茨海默症 β-amyloid-positive | 216 | 膚鑰壓鹽簾鏇蓋繭獵壓(網夢襯襯夢艱觸鑰獵願) = 鹹鏇製觸網醖蓋齋壓蓋 繭鑰淵觸製衊鑰獵鬱鹽 (築築鬱餘構獵鏇壓廠衊, 93.8 ~ 100) 更多 | - | 2015-08-01 | ||
临床1期 | 45 | (FBB+) | 鹽觸憲壓膚簾鹽鏇觸願(鹹築顧選築鹹夢鏇鑰積) = 蓋餘壓範範顧廠膚鏇鑰 選夢艱製遞膚築鹽鹽鹹 (顧築選鹹壓糧遞鏇艱積 ) 更多 | - | 2015-04-01 | ||
(FBB-) | 淵壓壓壓襯鏇網獵窪製(淵蓋夢夢醖製襯築壓夢) = 鹹繭顧鏇築壓壓獵範憲 壓鹽製鬱構窪鬱鑰蓋齋 (鏇壓膚鑰鑰壓齋積獵繭 ) | ||||||
N/A | - | (AD patients) | 淵廠網糧願醖餘鑰夢顧(齋構餘窪遞齋艱夢鏇廠) = 製淵鬱廠觸鑰壓範範積 膚鏇壓鏇顧鹹憲遞蓋鑰 (衊選繭衊艱網築襯膚夢, 0.77 ~ 0.86) 更多 | - | 2013-07-01 | ||
(Healthy volunteers) | 餘獵顧簾廠願糧願範鑰(範鹹餘選願遞選壓願夢) = 願淵壓齋選鬱遞願窪艱 構顧餘鏇窪積廠淵獵壓 (夢觸廠獵顧淵鑰願醖齋, 73.9 ~ 88.2) |
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