This phase II trial studies how well the addition of 18F-DOPA (amino acid) positron emission tomography (PET)/computed tomography (CT) to standard of care (SOC) imaging can improve the clinical management of patients with brain tumors in over 50% of cases. PET is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (radiotracer) to show this activity. CT scan uses X-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. PET/CT scans are hybrid scanners that combine both of the two modalities into a single scan. This allows images of both anatomy (CT) and function (PET) to be taken during the same scan. The 18F-DOPA PET/CT scan is done with a very small amount of a radioactive tracer called FDOPA. The PET/CT scan is then used to detect the location of tumors. Using the 18FDOPA-PET/CT scan in addition to the SOC scan may improve the clinical management of patients with brain tumors.

开始日期2024-11-11

申办/合作机构

Mayo Clinic

NCT05103618 / Not yet recruiting临床2期IIT

Evaluating the Physiological and Psychological Effects of a Novel Meditation Technique on Cerebral Activity Measured With Functional Magnetic Resonance Imaging(fMRI) and F-18 Fluorodopa PET Imaging

The purpose of this research is to use 18 F Fluorodopa positron emission tomography (FDOPA PET) to measure dopamine function, and utilize magnetic resonance imaging (MRI) to measure inflammatory and oxidative stress markers in persons with Parkinson's disease.
The overall goal of this study will be to further the understanding of the effects of a novel meditation technique called orgasmic meditation (OM) on these neurophysiological parameters.

开始日期2024-09-01

申办/合作机构

Thomas Jefferson University

NCT05512403 / Recruiting临床3期IIT

Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics as Biomarkers for the Improvement of Care of MRI Non-contrast Enhanced Gliomas

the investigators hypothesise that 18F-FDOPA PET kinetic parameters are good biomarkers to characterise suspected LGG brain lesions that exhibit no contrast on MRI, for identifying aggressive lesions. These parameters could constitute diagnostic biomarkers for this indication. This new diagnostic tool could enhance patient care in the short term in an evolving pathology affecting socially active subjects with a poor prognosis

开始日期2023-06-13

申办/合作机构

Centre Hospitalier Regional de Nancy

100 项与氟[18F]多巴相关的临床结果

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100 项与氟[18F]多巴相关的转化医学

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100 项与氟[18F]多巴相关的专利（医药）

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223

项与氟[18F]多巴相关的文献（医药）

2023-11-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

High Tumor Uptake on¹⁸F-FDOPA PET/CT Indicates Poor Prognosis in Patients with Metastatic Midgut Neuroendocrine Tumors: A Study from the Groupe d’étude des Tumeurs Endocrines and ENDOCAN-RENATEN Network

Article

作者: Cros, Jérôme ; Lebtahi, Rachida ; Lachachi, Choaib ; Taieb, David ; Ouvrard, Éric ; Cadiot, Guillaume ; Morland, David ; Bando-Delaunay, Aurélie ; Hentic, Olivia ; Perrier, Marine ; Imperiale, Alessio ; De Rycke, Ophélie ; de Mestier, Louis ; Goichot, Bernard ; Walter, Thomas ; Ruszniewski, Philippe ; Mennetrey, Clément

PET/CT with 6-¹⁸F-fluoro-l-dopa (¹⁸F-FDOPA) has high diagnostic performance for midgut neuroendocrine tumors (NETs). We explored the prognostic role of ¹⁸F-FDOPA PET/CT uptake in metastatic midgut NETs. Methods: We included, in a test cohort (n = 166) and a full external validation cohort (n = 86), all consecutive patients with metastatic midgut NETs who underwent ¹⁸F-FDOPA PET/CT in 5 expert centers from 2010 to 2021. We measured the maximal uptake (SUV_max and SUV_peak) of the tumor and nontumor liver on each ¹⁸F-FDOPA PET/CT scan. We measured overall survival (OS) from the time of PET/CT and assessed prognostic factors using Kaplan-Meier and multivariable Cox proportional-hazards analyses in the test cohort, with replication in the validation cohort. Results: Patients had similar characteristics in both cohorts. In the test cohort, median follow-up was 60.3 mo. Patients with an SUV_peak tumor-to-liver (T/L) ratio of more than 4.2 had significantly shorter survival than those with a ratio of 4.2 or less (P = 0.01), with a 5-y OS rate of 74.1% ± 4.5% versus 95% ± 3.4%, respectively. On multivariable analysis, an SUV_peak T/L ratio of more than 4.2 remained associated with shorter OS (hazard ratio, 2.30; 95% CI, 1.02-5.22; P = 0.046) after adjustment for age, grade, number of previous lines, number of metastatic sites, and presence of carcinoid syndrome. In the validation cohort, the 5-y OS rate was 100% versus 57.8% ± 12.5% in patients with an SUV_peak T/L ratio ≤ 4.2 or > 4.2, respectively (P = 0.075). An increasing SUV_peak T/L ratio over time tended to have a pejorative prognostic impact. Conclusion: Tumor uptake on ¹⁸F-FDOPA PET/CT is an independent prognostic factor in patients with metastatic midgut NETs.

2023-08-01·Clinical nuclear medicine

Discriminating Inflammatory Radiation-Related Changes From Early Recurrence in Patients With Glioblastomas: A Preliminary Analysis of 68 Ga-PSMA-11 PET/CT Compared With 18 F-FDOPA PET/CT.

Article

作者: Khayi, Fouzi ; Ducray, François ; Kryza, David ; Bonneville-Levard, Alice ; Maureille, Aurélien ; Larrouquere, Louis ; Moreau, Aurélie

PURPOSE OF THE REPORT:

Using morphological and functional imaging to discriminate recurrence from postradiation-related modifications in patients with glioblastomas remains challenging. This pilot study aimed to assess the feasibility of using 68 Ga-prostate-specific membrane antigen (PSMA) 11 PET/CT compared with 18 F-FDOPA PET/CT to detect early recurrence.

METHODS:

Nine patients followed up for glioblastomas who received MRI during 12 months of follow-up were referred for both 68 Ga-PSMA-11 and 18 F-FDOPA PET/CT. The SUV max , lesion-to-striatum ratio, lesion-to-normal parenchyma ratio, and lesion-to-salivary gland ratio were calculated.

RESULTS:

Good correlation between 18 F-FDOPA and 68 Ga-PSMA PET/CT findings was seen in 5 patients. In 4 patients, the findings of both examinations were consistent with recurrence but were better visualized with the PSMA PET/CT. Examinations of the fifth patient were suggestive of postradiation-related changes and were better analyzed with the PSMA PET/CT, which displayed relatively low uptake compared with DOPA PET/CT. Conversely, 4 patients showed conflicting results: recurrence was not detected on the PSMA PET/CT because of previously introduced bevacizumab treatment; in another patient, both examinations were consistent with recurrence, but there was an uptake mismatch at the suspected lesion sites, and 2 patients presented with inconsistent findings.

CONCLUSIONS:

Despite a few discrepancies, this study highlights the potential role of 68 Ga-PSMA-11 PET/CT for discriminating postradiation inflammation from recurrence. 68 Ga-PSMA-11 PET/CT has an excellent lesion-to-background ratio, and false-positive and false-negative results could be minimized through implementing certain protocols before performing the examination. More powerful prospective studies are required to validate our results.

2022-12-01·European journal of hybrid imaging

Comparison of [18F]DOPA and [68Ga]DOTA-TOC as a PET imaging tracer before peptide receptor radionuclide therapy

Article

作者: de Groot, Derk Jan A ; Veenstra, Emile B ; Noordzij, Walter ; Zandee, Wouter T ; Brabander, Tessa ; Brouwers, Adrienne H ; Hofland, Johannes ; Walenkamp, Annemiek M E

Abstract:

Background:

In treatment of neuroendocrine neoplasms (NENs), confirmation of somatostatin receptor expression with 68Ga-DOTA somatostatin analogues is mandatory to determine eligibility for peptide receptor radionuclide therapy (PRRT). [18F]DOPA can detect additional lesions compared to [68Ga]DOTA-TOC. The aim of this study was to explore differences in tumour detection of both tracers and their relevance for selecting patients for PRRT. We retrospectively studied eight patients with NENs who underwent both [68Ga]DOTA-TOC and carbidopa-enhanced [18F]DOPA PET/CT, before first-time PRRT with [177Lu]DOTA-TATE. Tracer order was influenced due to stock availability or to detect suspected metastases with a second tracer. On CT, disease control was defined as a lesion showing complete response, partial response, or stable disease, according to RECIST 1.1. criteria.

Results:

Seven patients with in total 89 lesions completed four infusions of 7.4 GBq [177Lu]DOTA-TATE, one patient received only two cycles. Before treatment, [18F]DOPA PET/CT detected significantly more lesions than [68Ga]DOTA-TOC PET/CT (79 vs. 62, p < .001). After treatment, no difference in number of lesions with disease control was found for [18F]DOPA-only (5/27) and [68Ga]DOTA-TOC-only lesions (4/10, p = .25). [18F]DOPA detected more liver metastases (24/27) compared to [68Ga]DOTA-TOC (7/10, p = .006). Six patients showed inpatient heterogeneity in treatment response between [18F]DOPA-only and [68Ga]DOTA-TOC-only lesions.

Conclusions:

Response to PRRT with [177Lu]DOTA-TATE was comparable for both [68Ga]DOTA-TOC- and [18F]DOPA-only NEN lesions. [18F]DOPA may be capable of predicting response to PRRT while finding more lesions compared to [68Ga]DOTA-TOC, although these additional lesions are often small of size and undetected by diagnostic CT.

项与氟[18F]多巴相关的新闻（医药）

2024-05-31

·同写意

拜耳帕金森病细胞疗法候选药物获美国FDA再生医学先进疗法认定丨会员动态

突破性疗法临床1期加速审批

2024-05-31

·Pharmaceutical Technology

FDA grants RMAT status for BlueRock’s Parkinson’s therapy

Bemdaneprocel is created to replace the dopamine-producing neurons lost due to Parkinson’s disease. Credit: Annick Vanblaere from Pixabay. The US Food and Drug Administration (FDA) has granted a regenerative medicine advanced therapy (RMAT) designation for BlueRock Therapeutics’ investigational cell therapy bemdaneprocel (BRT-DA01) for Parkinson’s disease. Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Top Guide for Drug Delivery Systems BlueRock is a wholly owned independently operated Bayer subsidiary. Bemdaneprocel is claimed to be the most clinically advanced cell therapy for Parkinson’s disease treatment in the US. The therapy is created to replace the dopamine-producing neurons lost in the course of the disease. It was assessed in the multi-site, multicentre, non-randomised, open-label, non-controlled study. See Also: Dupixent gets closer to EU approval as the FDA delays its decision on COPD Bristol Myers Squibb’s Breyanzi gains FDA approval for lymphoma The trial involved 12 subjects diagnosed with Parkinson’s disease who underwent surgical transplantation of bemdaneprocel cells into the post-commissural putamen bilaterally, followed by a one-year immunosuppression regimen. Data from the trial, announced in March 2024, indicated that bemdaneprocel was well tolerated and did not present major safety issues up to 18 months post-treatment. Furthermore, an increase in the F-DOPA PET imaging signal was observed after the cessation of immune suppression therapy at 12 months, suggesting that the transplanted cells survive and engraft in the brain. The RMAT designation is managed by the FDA’s Center for Biologics, Evaluation and Research (CBER). It is specifically for investigational regenerative therapies, including cell therapies, aimed at treating, modifying, reversing or curing serious ailments. Therapies granted RMAT status can benefit from expedited development review and development planning guidance from senior CBER managers. This status also facilitates early discussions about possible surrogate endpoints and strategies to support accelerated approval and satisfy post-approval needs. BlueRock Therapeutics president and CEO Seth Ettenberg stated: “We are excited about the positive data from the bemdaneprocel Phase I clinical trial and believe it has great potential to help patients living with Parkinson’s disease regain functions they have lost to the disease. “Now with this RMAT designation in hand, we look forward to closely collaborating with the FDA to ready this programme for Phase II clinical studies.” Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

临床1期细胞疗法基因疗法

2024-05-30

·拜耳中国

拜耳帕金森病细胞疗法候选药物获美国FDA再生医学先进疗法认定

在获得再生医学先进疗法（RMAT）认定之前，bemdaneprocel I期临床试验结果表明其耐受性良好，且在18个月内没有出现重大安全问题Bemdaneprocel是美国临床最先进的研究性细胞疗法，用于治疗帕金森病患者近日，拜耳和BlueRock Therapeutics LP（一家临床阶段细胞治疗公司，拜耳公司全资独立运营的子公司）宣布，BlueRock用于治疗帕金森病的研究性细胞疗法bemdaneprocel已获得美国食品药品监督管理局（FDA）的再生医学先进疗法（RMAT）认定。Seth EttenbergBlueRock Therapeutics总裁兼首席执行官“我们对bemdaneprocel I期临床试验的积极数据感到兴奋，并相信它具有帮助帕金森病患者恢复因疾病而丧失的功能的巨大潜力。基于RMAT认定，我们期待与FDA密切合作，为该项目的II期临床研究做好准备。”Bemdaneprocel是美国治疗帕金森病的临床最先进的研究性细胞疗法。3月公布的I期临床试验数据表明，bemdaneprocel在18个月时耐受性良好，没有出现重大安全问题。此外，根据研究方案中的定义，在停止免疫抑制治疗12个月后，观察到F-DOPA PET成像信号有所增加，这表明移植的细胞能够存活并植入大脑。RMAT项目由FDA生物制品评估和研究中心（CBER）管理，致力于细胞疗法等研究性再生医学，旨在治疗、改变、逆转或治愈严重疾病。获得RMAT认定的研究性疗法有资格获得CBER高级管理人员的快速开发审查和开发规划指导。RMAT还为讨论潜在替代终点，以及加速批准和满足批准后要求敞开了大门。Christian Rommel拜耳处方药事业部执行委员会成员兼全球研发负责人“Bemdaneprocel获得RMAT认定证明，该候选药物有可能从根本上改变我们对帕金森病治疗的看法。我们致力于为患者提供突破性创新，并为bemdaneprocel进一步扫清开发障碍感到自豪和兴奋。”关于拜耳拜耳作为一家跨国企业，在生命科学领域的健康与农业方面具有核心竞争力。公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2023财年，拜耳的员工人数约为100,000名，销售额为476亿欧元。不计特殊项目的研究开发投入为58亿欧元。更多信息请见www.bayer.com。前瞻性声明本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站http://www.bayer.com/上公开的拜耳各项报告。本公司没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。

突破性疗法加速审批

100 项与氟[18F]多巴相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	氟[18F]多巴	V09IX	DB13848

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
帕金森障碍	美国	The Feinstein Institutes for Medical Research	2019-10-10
诊断试剂	瑞士	Novartis Pharma AG	2016-11-01

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临床结果

适应症

分期

评价

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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


NCT03778294 (CTgov)	临床2期	胶质母细胞瘤	43	Proton Beam Radiation Therapy+temozolomide+Computed Tomography	簾膚築醖醖夢夢襯鑰顧(膚艱願衊淵鬱網鬱窪鑰) = 蓋淵獵蓋選襯壓艱窪選願憲繭範製憲願憲鹽廠 (膚憲鹽築壓艱膚鬱壓窪, 觸壓齋餘餘鬱鹹鑰願膚 ~ 鑰顧繭憲醖網齋膚糧積) 更多	-	2023-11-14
NCT03778294 (ASCO2023) 人工标引	临床2期	胶质母细胞瘤一线 MGMT	39	18F-DOPA concurrent/adjuvant temozolomide	鹹顧廠鹹繭製淵選衊獵(築糧鹹艱簾壓鏇選築廠) = 艱選簾壓鬱餘膚製願積製願蓋餘築憲簾繭網簾 (壓網範簾襯獵簾壓蓋鬱 ) 达到更多	积极	2023-05-31
NCT03778294 (ASCO2023) 人工标引	临床2期	胶质母细胞瘤一线 MGMT	39	18F-DOPA concurrent/adjuvant temozolomide (MGMT methylation)	鹹顧廠鹹繭製淵選衊獵(築糧鹹艱簾壓鏇選築廠) = 糧鏇衊鏇鹽築觸齋廠製製願蓋餘築憲簾繭網簾 (壓網範簾襯獵簾壓蓋鬱 ) 达到更多	积极	2023-05-31
SNMMI2022	N/A	先天性高胰岛素血症	-	[18F] DOPA18F-DOPAPA (18F-DOPA PET-CT)	築膚壓齋鹹遞範獵願淵(醖艱壓餘醖壓繭鏇繭窪) = 艱網醖餘膚壓繭衊壓夢襯膚夢網鬱鏇衊膚窪糧 (淵膚願淵積範淵獵簾餘 )	-	2022-08-08
SNMMI2022	N/A	胶质瘤	-	[18F]-FDOPA (Progression)	積範遞製願繭齋餘壓衊(廠鹽製製繭繭壓衊醖憲) = 願膚艱製鹽鬱顧蓋膚觸願網製襯夢齋遞簾醖憲 (遞築繭遞淵範淵繭餘鹽, 9)	-	2022-08-08
SNMMI2022	N/A	胶质瘤	-	[18F]-FDOPA (Radionecrosis)	積範遞製願繭齋餘壓衊(廠鹽製製繭繭壓衊醖憲) = 憲觸製鹽餘選範憲遞膚願網製襯夢齋遞簾醖憲 (遞築繭遞淵範淵繭餘鹽, 9)	-	2022-08-08
SNMMI2022	N/A	嗜铬细胞瘤	-	68Ga-DOTATATE PET/CT	壓壓範選夢夢簾鹽繭艱(鹹齋憲淵廠製壓繭膚願) = 遞壓願繭鏇憲夢遞願糧艱顧觸鹹憲範窪憲簾製 (觸襯齋醖餘襯餘觸簾積, 21.2 ~ 86.3)	-	2022-08-08
SNMMI2022	N/A	多发性内分泌瘤病2a型	-	68Ga-DOTATATE PET/CT	願觸獵壓網積鑰獵簾淵(遞齋顧獵醖簾糧鬱遞繭) = 廠鑰範窪觸廠鹹顧築廠製願廠鏇鑰網範蓋鬱觸 (齋廠範顧餘蓋艱餘鹽鑰, 51.9 ~ 95.7)	-	2022-08-08
NCT03242824 (MC167B, CTgov)	临床2期	复发性恶性胶质瘤	21	Intensity-Modulated Radiation Therapy+Fluorine F 18 Fluorodopa	觸憲壓廠鹽製鑰鬱願選(願壓觸廠憲選淵淵獵獵) = 鏇鬱繭艱製鏇鬱簾築憲廠選襯範窪蓋網鏇淵艱 (餘積蓋鬱鹹壓獵糧鏇鏇, 膚鹽構鑰夢蓋鬱鬱鹹鹹 ~ 糧淵鑰齋窪築鬱壓蓋夢) 更多	-	2022-07-05
NCT01991977 (Pubmed \| Int J Radiat Oncol Biol Phys)	临床2期	胶质母细胞瘤	75	Dose-escalated radiotherapy (DERT)	構餘構鏇鬱醖繭願獵築(簾艱淵憲製範窪簾壓壓) = Grade 3 CNS necrosis occurred in 13% of patients but treatment with bevacizumab improved symptoms in all cases 夢夢鏇範獵繭鹽廠鹽淵 (餘積鑰構憲淵齋觸憲窪 ) 更多	-	2021-03-23
NCT01991977 (Pubmed \| Int J Radiat Oncol Biol Phys)	临床2期	胶质母细胞瘤	75	<sup>18</sup>F-DOPA (Historical controls)		-	2021-03-23
ASTRO	N/A	胶质母细胞瘤	-	18f-Dopa18FDOPA (DE-RT with 18FDOPA PET guidance)	壓製構夢願築淵繭憲糧(醖襯壓鑰選繭蓋範繭窪) = most common grade 3 toxicity (8 patients) which generally resolved within one month 範糧衊鬱鑰淵選憲醖簾 (蓋築積網淵蓋糧簾衊積 ) 更多	-	2020-11-01
ASTRO	N/A	胶质母细胞瘤	-	18f-Dopa (Standard RT (60Gy))		-	2020-11-01
NCT01991977 (CTgov)	临床2期	胶质瘤	91	Diffusion Weighted Imaging+Fluorine F 18 Fluorodopa+Temozolomide	鬱醖製遞築築鹽積願衊(壓選鏇鏇壓膚齋壓顧窪) = 壓遞窪獵網鬱艱選顧鬱鬱餘觸積醖積顧願齋網 (鏇遞鹽糧簾齋選醖製繭, 膚積範憲積淵鏇選鹹艱 ~ 鏇築鏇蓋願獵齋夢夢構) 更多	-	2020-04-03