The purpose of this study is to compare/harmonize cross-sectional and longitudinal tau tangle measurements obtained with the tau PET radiopharmaceuticals Flortaucipir and MK-6240 to elucidate the advantages and caveats of their use in clinical trials/practice and provide parameters to integrate their estimates.

开始日期2021-11-23

申办/合作机构

University of Pittsburgh

[+1]

NCT01886820 / Unknown status临床3期

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology

To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology

开始日期2013-06-01

申办/合作机构

Navidea Biopharmaceuticals, Inc.

NCT01812213 / Terminated临床2期

Beta-Amyloid Imaging With [18F]NAV4694 Positron Emission Tomography (PET) in Predicting Progression to Alzheimer's Disease (AD) in Subjects With Mild Cognitive Impairment (MCI)

To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with mild cognitive impairment (MCI) who progress to Alzheimer's disease (AD) from those who do not.

开始日期2013-03-01

申办/合作机构

Navidea Biopharmaceuticals, Inc.

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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项与 Flutafuranol F-18 相关的文献（医药）

2024-01-01·Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring

Inter‐scanner Aβ‐PET harmonization using barrel phantom spatial resolution matching

Article

作者: Ruwanpathirana, Gihan P. ; Davey, Catherine E. ; Rowe, Christopher C. ; Johnston, Leigh A. ; Masters, Colin L. ; Williams, Robert C.

AbstractINTRODUCTIONThe standardized uptake value ratio (SUVR) is used to measure amyloid beta–positron emission tomography (Aβ‐PET) uptake in the brainDifferences in PET scanner technologies and image reconstruction techniques can lead to variability in PET images across scanners. This poses a challenge for Aβ‐PET studies conducted in multiple centers. The aim of harmonization is to achieve consistent Aβ‐PET measurements across different scanners. In this study, we propose an Aβ‐PET harmonization method of matching spatial resolution, as measured via a barrel phantom, across PET scanners. Our approach was validated using paired subject data, for which patients were imaged on multiple scanners.METHODSIn this study, three different PET scanners were evaluated: the Siemens Biograph Vision 600, Siemens Biograph molecular computed tomography (mCT), and Philips Gemini TF64. A total of five, eight, and five subjects were each scanned twice with [18F]‐NAV4694 across Vision‐mCT, mCT‐Philips, and Vision‐Philips scanner pairs. The Vision and mCT scans were reconstructed using various iterations, subsets, and post‐reconstruction Gaussian smoothing, whereas only one reconstruction configuration was used for the Philips scans. The full‐width at half‐maximum (FWHM) of each reconstruction configuration was calculated using [18F]‐filled barrel phantom scans with the Society of Nuclear Medicine and Molecular Imaging (SNMMI) phantom analysis toolkit. Regional SUVRs were calculated from 72 brain regions using the automated anatomical labelling atlas 3 (AAL3) atlas for each subject and reconstruction configuration. Statistical similarity between SUVRs was assessed using paired (within subject) t‐tests for each pair of reconstructions across scanners; the higher the p‐value, the greater the similarity between the SUVRs.RESULTSVision‐mCT harmonization: Vision reconstruction with FWHM = 4.10 mm and mCT reconstruction with FWHM = 4.30 mm gave the maximal statistical similarity (maximum p‐value) between regional SUVRs. Philips‐mCT harmonization: The FWHM of the Philips reconstruction was 8.2 mm and the mCT reconstruction with the FWHM of 9.35 mm, which gave the maximal statistical similarity between regional SUVRs. Philips–Vision harmonization: The Vision reconstruction with an FWHM of 9.1 mm gave the maximal statistical similarity between regional SUVRs when compared with the Philips reconstruction of 8.2 mm and were selected as the harmonized for each scanner pair.CONCLUSIONBased on data obtained from three sets of participants, each scanned on a pair of PET scanners, it has been verified that using reconstruction configurations that produce matched‐barrel, phantom spatial resolutions results in maximally harmonized Aβ‐PET quantitation between scanner pairs. This finding is encouraging for the use of PET scanners in multi‐center trials or updates during longitudinal studies.Highlights

Question: Does the process of matching the barrel phantom‐derived spatial resolution between scanners harmonize amyloid beta–standardized uptake value ratio (Aβ‐SUVR) quantitation?

Pertinent findings: It has been validated that reconstruction pairs with matched barrel phantom‐derived spatial resolution maximize the similarity between subjects paired Aβ‐PET (positron emission tomography) SUVR values recorded on two scanners.

Implications for patient care: Harmonization between scanners in multi‐center trials and PET camera updates in longitudinal studies can be achieved using a simple and efficient phantom measurement procedure, beneficial for the validity of Aβ‐PET quantitation measurements.

2023-07-01·Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring

Amyloid beta plaque accumulation with longitudinal [18F]AZD4694 PET

Article

作者: Rosa‐Neto, Pedro ; Gauthie, Serge ; Wang, Yi‐Ting ; Servaes, Stijn ; Saha‐Chaudhuri, Paramita ; Pallen, Vanessa ; Vitali, Paolo ; Fernandez‐Arias, Jaime ; Vermeiren, Marie ; Lussier, Firoza Z. ; Pascoal, Tharick A. ; Massarweh, Gassan ; Rahmouni, Nesrine ; Tissot, Cécile ; Kunach, Peter ; Chamoun, Mira ; Bezgin, Gleb ; Therriault, Joseph ; Stevenson, Jenna ; Soucy, Jean‐Paul

AbstractIntroduction[18F]AZD4694 is an amyloid beta (Aβ) imaging agent used in several observational studies and clinical trials. However, no studies have yet published data on longitudinal Aβ accumulation measured with [18F]AZD4694.MethodsWe assessed 146 individuals who were evaluated with [18F]AZD4694 at baseline and 2‐year follow‐up. We calculated annual rates of [18F]AZD4694 change for clinically defined and biomarker‐defined groupsResultsCognitively unimpaired (CU) older adults displayed subtle [18F]AZD4694 standardized uptake value ratio (SUVR) accumulation over the follow‐up period. In contrast, Aβ positive CU older adults displayed higher annual [18F]AZD4694 SUVR increases. [18F]AZD4694 SUVR accumulation in Aβ positive mild cognitive impairment (MCI) and dementia was modest across the neocortexDiscussionLarger increases in [18F]AZD4694 SUVR were observed in CU individuals who had abnormal amyloid positron emission tomography levels at baseline. [18F]AZD4694 can be used to monitor Aβ levels in therapeutic trials as well as clinical settings, particularly prior to initiating anti‐amyloid therapies.

2023-03-01·Journal of Nuclear Medicine

Evaluation of Tau Radiotracers in Chronic Traumatic Encephalopathy

Article

作者: Vasdev, Neil ; Varlow, Cassis

Chronic traumatic encephalopathy (CTE) is a neurologic disorder associated with head injuries, diagnosed by the perivascular accumulation of hyperphosphorylated tau protein (phospho-tau) identified at autopsy. Tau PET radiopharmaceuticals developed for imaging Alzheimer disease are under evaluation for brain injuries. The goal of this study was to conduct a head-to-head in vitro evaluation of 5 tau PET radiotracers in subjects pathologically diagnosed with CTE. Methods: Autoradiography was used to assess the specific binding and distribution of ³H-flortaucipir (also known as Tauvid, AV-1451, and T807), ³H-MK-6240 (also known as florquinitau), ³H-PI-2620, ³H-APN-1607 (also known as PM-PBB3 and florzolotau), and ³H-CBD-2115 (also known as ³H-OXD-2115) in fresh-frozen human postmortem CTE brain tissue (stages I-IV). Immunohistochemistry was performed for phospho-tau with AT8, 3R tau with RD3, 4R tau with RD4 and amyloid-β with 6F/3D antibodies. Tau target density (maximum specific binding) was quantified by saturation analysis with ³H-flortaucipir in tissue sections. Results: ³H-flortaucipir demonstrated a positive signal in all CTE cases examined, with varying degrees of specific binding (68.7% ± 10.5%; n = 12) defined by homologous blockade and to a lesser extent by heterologous blockade with MK-6240 (27.3% ± 13.6%; n = 12). The ³H-flortaucipir signal was also displaced by the monoamine oxidase (MAO)-A inhibitor clorgyline (43.9% ± 4.6%; n = 3), indicating off-target binding to MAO-A. ³H-APN-1607 was moderately displaced in homologous blocking studies and was not displaced by ³H-flortaucipir; however, substantial displacement was observed when blocking with the β-amyloid-targeting compound NAV-4694. ³H-MK-6240 and ³H-PI-2620 had negligible binding in all but 2 CTE IV cases, and binding may be attributed to pathology severity or mixed Alzheimer disease/CTE pathology. ³H-CBD-2115 showed moderate binding, displaced under homologous blockade, and aligned with 4R-tau immunostaining. Conclusion: In human CTE tissues, ³H-flortaucipir and ³H-APN-1607 revealed off-target binding to MAO-A and amyloid-β, respectively, and should be considered if these radiotracers are used in PET imaging studies of patients with brain injuries. ³H-MK-6240 and ³H-PI-2620 bind to CTE tau in severe- or mixed-pathology cases, and their respective ¹⁸F PET radiotracers warrant further evaluation in patients with severe suspected CTE.

项与 Flutafuranol F-18 相关的新闻（医药）

2024-09-09

·Business Wire

Enigma Biomedical - USA Announces Collaboration with Alamar Biosciences to Advance the Field of Diagnostics for Neurodegenerative Diseases

KNOXVILLE, Tenn. & FREMONT, Calif.--( BUSINESS WIRE )--Enigma Biomedical USA (EB) today announced a collaboration with Alamar Biosciences in the field of neurology. Through this collaboration, EB has a non-exclusive right to introduce Alamar’s protein detection and measurement technologies, including its ARGO™ HT instrument and NULISA™ reagent kits, to academic and pharma customers in the field of neurology research. “We are excited to collaborate with Enigma to combine the power of high sensitivity, multiplexed immunoassays with high quality imaging to advance the field of neuro diagnostics,” said Yuling Luo, Founder, Chairman and CEO of Alamar Biosciences. This collaboration is designed to yield a large data set of results from neuroimaging and immunoassay from biofluids, which, together, are expected to lead to the development of more efficient diagnostic workflow solutions for patient-centric therapies. Through its affiliate, Enigma Biointelligence (EBI), EB will enable users to order Alamar’s high sensitivity, high specificity immunoassays directly from EBI’s Minerva Bio Platform software. EBI’s Health Grid software will then allow academic and pharma study sponsors to collect, manage and interpret data generated within their studies, including data generated using EB’s PET tracers and the NULISA biofluid based tests. Through this collaboration, EB and Alamar expect to develop analytics products using data generated by shared customers. “Enigma and our affiliate companies are focused on providing information and technologies to researchers and clinicians to improve brain health,” said Rick Hiatt, Chief Executive Officer of Enigma Biomedical USA. “We are thrilled to welcome Alamar to our growing list of first-class partners, who all together share our company’s mission and vision.” “I am confident that the combination of Alamar’s and EBI’s technologies will deliver scalable and accessible diagnostic solutions for patients,” said Dr. Hartmuth Kolb, Chief Scientific Officer of Enigma Biomedical USA. About Enigma Biomedical - USA Enigma Biomedical USA’s vision is to be the premier provider of imaging biomarkers for neurological pathologies, associated information technology, and related tools to accelerate the development, approval, and adoption of effective therapies to treat neurodegenerative diseases. EB’s neuroimaging biomarkers provide Pharma and Academic researchers with state of the art tools for enabling Disease-Modifying Therapy development with the highest precision and accuracy. In pursuit of this vision, subsidiaries of EB have provided the best-in-class Tau and Amyloid PET imaging biomarkers, MK-6240 and NAV-4694, to our partners to enable their research efforts. Both tracers have recently been acquired by a third party for further development. EB also recently announced a partnership with AbbVie to explore their novel 4R Tau PET Imaging Biomarkers.

2024-07-23

·先通医药

先通医药海外参股公司Meilleur及其Aβ-PET显像剂NAV-4694被收购

近日,先通医药海外参股公司Meilleur及其用于治疗阿尔茨海默病的新一代Aβ-PET显像剂NAV-4694被纳斯达克上市公司Lantheus收购。美国国家老龄化研究所和阿尔茨海默病协会（NIA-AA）工作组最新发布的修订版指南指出，阿尔茨海默病应使用基于蛋白质的生物标志物进行生物学定义，包括Aβ和Tau在内的生物标志物可用于诊断阿尔茨海默病并提供其严重程度的指标。1 NAV-4694目前正处于临床Ⅲ期开发阶段，已被广泛用于学术和行业的研究性治疗试验。NAV-4694与Lantheus的下一代18F 标记Tau-PET显像剂MK-6240（florquinitau）形成互补，扩大了Lantheus的阿尔茨海默病诊断产品组合。 MK-6240是一款18F标记的高亲和力Tau蛋白PET显像剂。该药物对Tau蛋白的探测显像对比度高，可无创、精准、定位、定量地呈现阿尔兹海默病患者脑部Tau蛋白沉积的病理变化。此前，Lantheus通过收购Cerveau公司获得了MK-6240的全球权益，而先通医药是Cerveau的股东之一。根据现有的再许可协议，先通医药保留了MK-6240在中国的权益。 Aβ-PET阳性显像能够提示存在AD病理改变，结合Tau-PET检测结果，对AD早期诊断、鉴别诊断、抗Aβ治疗后疗效评价、AD药物临床试验患者筛选具有显著价值。根据协议条款，Lantheus 将支付预付款及潜在的额外开发和商业里程碑付款。此外，Lantheus 还将为研究收入和商业销售支付特许权使用费。该协议以股票购买的形式签订，规定Meilleur将在交易完成后的规定时间内提供过渡和临床开发服务。先通医药CEO唐艳旻表示：“这是一次激动人心的收购，我们非常看好Aβ-PET和Tau-PE在阿尔茨海默病早期诊断，临床分期及治疗前后疗效评估等方面的应用潜力,它们的联合使用将为阿尔茨海默病的诊疗决策提供有力的证据。” 在中国,先通医药则通过Aβ-PET显像剂欧韦宁®氟[18F]贝他苯注射液与Tau-PET显像剂MK-6240的组合,助力阿尔茨海默病患者实现早诊早治。参考文献 1.Jack CR, et.al. Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup. Alzheimer’s Dement 2024;1-27. https://doi-org.libproxy1.nus.edu.sg/10.1002/alz.13859 先通医药是中国创新放射性药物领域的领先企业，专注于放射性药物的研发创新及落地应用以改善患者的健康水平。先通医药于2014年正式开展新一代放射性药物的研发，总部位于北京，在上海设有研发中心，在江苏、广东、四川建设有现代化放射性药物智能生产基地；同时，在美国设有分支机构，并与十几家跨国药企达成战略合作。全球放射性药物主要应用于神经、心血管、肿瘤三大疾病领域，先通医药已实现全面布局，并拥有20+精准诊断和靶向治疗放射性药物研发管线。凭借自身的研发优势，先通医药获得了投资机构的青睐，2020年4月至今，已成功募资超20亿元人民币，未来不久将登陆主要资本市场，成为中国放射性药物领域的创新力量。内容来源于网络，如有侵权，请联系删除。

并购放射疗法

2024-07-15

·FierceBiotech

Lantheus acquires Alzheimer’s PET diagnostic developer Meilleur Technologies

Lantheus pitched Meilleur’s amyloid-targeting NAV-4694 as a complement to its PET agent MK-6240, which is aimed at Alzheimer’s tau tangles. Lantheus is expanding its holdings of PET imaging agents for Alzheimer’s disease, with the acquisition of Meilleur Technologies. The deal grants Lantheus exclusive worldwide rights to Meilleur’s radiopharmaceutical diagnostic that highlights beta amyloid plaques in the brain. The injectable agent—known as NAV-4694, or F18-flutafuranol—is currently in phase 3 development. The acquisition comes just days after the Centers for Medicare and Medicaid Services proposed a separate payment pathway for certain diagnostic radiopharmaceuticals and nuclear medicine imaging agents—instead of bundling them as part of the procedure, as it had in the past. The change was put forward in CMS’ proposal for payment systems among hospital outpatient services and ambulatory surgical centers, set for the 2025 calendar year. Lantheus’ stock price jumped nearly 60% on the news. The deal also follows the FDA’s approval earlier this month of Eli Lilly’s Kisunla (donanemab-abzt) treatment for Alzheimer’s, seen as a challenger to Biogen and Eisai’s Leqembi in a newly burgeoning area of anti-amyloid therapies. “This acquisition solidifies our commitment to neurology, specifically for Alzheimer’s disease management, and reinforces our radiopharmaceutical leadership,” Lantheus CEO Brian Markison said in a statement, which pitched Meilleur’s NAV-4694 as a complement to the company’s PET agent MK-6240, aimed at Alzheimer’s tau tangles. The companies estimate that nearly 12 million people are living with mild cognitive impairment or Alzheimer’s disease in the U.S. today, a number that may pass 20 million by 2050. “With the combination of MK-6240 and NAV-4694, we are poised to provide important insights for guiding the use and assessing the impact of novel disease-modifying Alzheimer’s treatments,” Markison said. Lantheus previously acquired MK-6240, an F18-labeled agent also known as florquinitau, in February 2023 through its buyout of Cerveau Technologies. While the exact financial terms of Lantheus’ deal with Meilleur were not disclosed, the companies said the stock purchase agreement includes an upfront payment as well as additional R&D and commercial milestones, plus royalties. Meilleur will also provide transitional clinical development services for a set time. “We are excited by the potential of NAV-4694 for earlier identification of Alzheimer’s patients, empowering clinicians to select suitable candidates for timely therapeutic interventions,” said Meilleur CEO Rick Hiatt. “With Lantheus’ expertise in radiopharmaceutical diagnostics and ability to scale operations, I am confident that Lantheus is the ideal company to bring this late-stage biomarker through pivotal trials and into commercialization to one day benefit patients at risk of Alzheimer’s disease.”

并购临床3期诊断试剂

100 项与 Flutafuranol F-18 相关的药物交易

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研发状态

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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	-	阿斯利康制药有限公司	-
阿尔茨海默症	临床3期	-	Cerveau Technologies, Inc.初创企业	-
认知功能障碍	临床2期	-	Cerveau Technologies, Inc.初创企业	-
认知功能障碍	临床2期	-	阿斯利康制药有限公司	-
轻度认知障碍	临床1期	美国	Navidea Biopharmaceuticals, Inc.	2013-03-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01812213 (NAV4-04, CTgov)	临床2期	阿尔茨海默症 \| 轻度认知障碍	76	[18F]NAV4694	願範範蓋壓顧遞鏇鹹襯(鬱網獵網襯鑰網遞鏇餘) = 簾鹽醖遞網築獵鏇壓蓋鬱蓋選糧餘繭構築積簾 (網願窪願鹹選構鹽網構, 糧選憲積齋網襯鹽醖餘 ~ 構獵築襯齋構壓鏇餘襯) 更多	-	2024-08-14
AAIC2013	N/A	阿尔茨海默症	-	[18F]NAV4694	醖齋廠鏇鬱餘糧繭餘艱(鹹淵膚鑰壓選積蓋憲鏇) = 網獵壓鏇衊膚鏇鑰艱鏇鬱鏇餘構顧餘齋簾製鑰 (壓簾製蓋蓋廠憲鹹糧鑰 )	-	2013-07-01
				[11C]PIB	醖齋廠鏇鬱餘糧繭餘艱(鹹淵膚鑰壓選積蓋憲鏇) = 襯憲繭蓋淵鬱齋鬱製蓋鬱鏇餘構顧餘齋簾製鑰 (壓簾製蓋蓋廠憲鹹糧鑰 )
AAIC2012	N/A	痴呆	-	11C-PiB	夢積艱觸築網簾築衊鏇(構鏇廠衊觸積壓鹹遞壓) = 壓製積鬱顧齋簾艱製襯憲齋鬱顧糧鏇鏇鏇觸憲 (醖築鹹糧膚選艱顧遞夢 ) 更多	-	2012-07-01
				18F-AZD4694	夢積艱觸築網簾築衊鏇(構鏇廠衊觸積壓鹹遞壓) = 襯蓋蓋鑰鬱餘繭壓顧選憲齋鬱顧糧鏇鏇鏇觸憲 (醖築鹹糧膚選艱顧遞夢 ) 更多