预约演示
更新于：2026-02-07
Flutafuranol F-18
更新于：2026-02-07
概要
基本信息
原研机构 |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
分子式C14H11FN2O2 |
InChIKeyMYNQXTDIPMCJCR-HUYCHCPVSA-N |
CAS号1211333-21-9 |
关联
8
项与 Flutafuranol F-18 相关的临床试验NCT06416072
Alzheimer's Plasma Extension
NCT05617014
Alzheimer's Disease Neuroimaging Initiative 4 (ADNI4)
NCT05361382
Longitudinal Multicenter Head-to-Head Harmonization of Tau PET Tracers
100 项与 Flutafuranol F-18 相关的临床结果
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100 项与 Flutafuranol F-18 相关的转化医学
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100 项与 Flutafuranol F-18 相关的专利（医药）
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46
项与 Flutafuranol F-18 相关的文献（医药）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 ; Bauer‐Negrini, Guilherme ; Gordon, Brian A. ; Soleimani‐Meigooni, David N. ; Fortea, Juan ; Tudorascu, Dana L ; Ferreira, Pamela C.L. ; Lowe, Val J ; Baker, Suzanne L. ; Karikari, Thomas K ; Cehula, Juli ; Povala, Guilherme ; Pascual, Belen ; Oh, Hwamee ; Lussier, Firoza Z ; Amaral, Livia ; Bellaver, Bruna
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.
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.
2025-12-01Alzheimers & Dementia
The impact of AI correction on Centiloid in a same subject visual read comparison of
18
F‐Florbetapir and
18
F‐NAV4694 Aβ PET
Article
作者: Dore, Vincent ; Bourgeat, Pierrick ; Huang, Kun ; Feizpour, Azadeh ; Sutherland, Antony ; Toh, H. B. ; Poon, Aurora ; Kaewchur, Tawika ; Thientunyakit, Tanyaluck ; Villemagne, Victor L. ; Fripp, Jurgen ; Paranawithana, Ishara ; Rowe, Christopher C.
Abstract:
Background:
Visual read of Aβ PET remains standard clinical practice.
18
F‐NAV4694 (NAV) has high affinity for Aβ and low non‐specific binding so may be more accurate than older Aβ tracers. We compared visual read of NAV to
18
F‐Florbetapir (FBP) PET using standard and AI corrected Centiloid (CL) thresholds as gold standard.
Method:
150 participants (71.3±6.0 years) in the AIBL study underwent both scans within 2 years. Scans were read by 6 nuclear medicine physicians blinded to CL. Reader performance was compared against various CL thresholds. CL was measured with CapAIBL using a) the standard method, b) a composite cerebellum plus hemispheric white matter reference region for FBP and c) with an AI correction method for the CL SUVR (DeepSUVR). The DeepSUVR correction was learnt from a separate dataset of longitudinal scans where unexpected temporal changes were penalized and a tracer specific SUVR correction factor was developed for application to single scans.
Result:
CL frequency distribution graphs differed for NAV and FBP. Applying the DeepSUVR correction improved the correlation (R
2
) between NAV and FBP CL from 0.82 to 0.94, predominantly by boosting many mid‐range FBP CL values and reducing FBP variance around zero CL (Figure 1). The FBP composite reference region had a similar though less marked effect. The thresholds that produced peak visual read accuracy with standard and DeepSUVR CL methods were 15CL and 11CL for NAV, and 29CL and 21CL for FBP (Figure 2). Mean sensitivity at peak accuracy thresholds was higher in NAV with 97% for standard and 96% for DeepSUVR methods compared to 93% for both methods in FBP. Mean specificity at the same thresholds was similar with 95% for NAV and FBP with standard CL while DeepSUVR produced a specificity of 97% for both tracers.
Conclusion:
Visual read of amyloid PET can accurately detect levels of amyloid below the traditional thresholds of 20 or 25CL for a positive scan. Visual read thresholds vary by tracer and reader experience. AI correction of CL with the DeepSUVR method significantly improves the performance of Florbetapir but NAV4694 remains more sensitive to low amyloid levels.
27
项与 Flutafuranol F-18 相关的新闻（医药）2026-01-20
2025-12-16
放射疗法抗体药物偶联物并购
100 项与 Flutafuranol F-18 相关的药物交易
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研发状态
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 |
|---|---|---|---|---|
| 阿尔茨海默症 | 临床3期 | 美国 | 2013-06-01 | |
| 轻度认知障碍 | 临床2期 | 美国 | 2013-03-01 | |
| 认知功能障碍 | 临床2期 | - | - | |
| 认知功能障碍 | 临床2期 | - | - |
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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2期 | 76 | 廠襯願憲鹹鬱衊淵築構 = 鏇鹹夢艱範選餘鑰憲鏇 窪壓選觸獵鹽餘廠蓋顧 (衊鹽憲構鹽壓網蓋夢繭, 製艱糧積觸網獵鏇願襯 ~ 淵構醖繭鹽憲繭夢夢積) 更多 | - | 2024-08-14 |
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