{"title":"sup>18</sup> f -氟吡嗪临床试验进展","authors":"Naoya Matsumoto","doi":"10.17996/anc.23-00011","DOIUrl":null,"url":null,"abstract":"18F-flurpiridaz is a novel positron emission computed tomography (PET) tracer in ongoing clinical trials in United States and Japan. A phase III prospective, open-label, multi-center study to assess the feasibility of 18F-flurpiridaz was reported by Maddahi et al. in patients with known or suspected coronary artery disease (CAD) in 2020 in United States (1). 18F-flurpiridaz binds to mitochondrial complex 1 and would distribute to the myocardium with its higher extraction fraction than those in single-photon emission computed tomography (SPECT) tracers (2). In that phase III trial, 795 participants with known or suspected CAD showed that sensitivity of 18F-flurpiridaz PET (for detection of ≥50% stenosis by invasive coronary angiography) was 71.9%, significantly (p < 0.001) higher than 99mTc labeled SPECT agent (53.7%), while specificity did not meet the prespecified noninferiority criterion (76.2% vs. 86.6%, p=NS) (1). Therefore, a second phase III Food and Drug Administration trial was planned and completed by GE Healthcare. Late phase II open-label multicenter study of PET scan using 18F-flurpiridaz (named NMB58 in Japan) to assess myocardial blood flow and diagnostic feasibility in patients with known or suspected CAD started in Japan of 2023.","PeriodicalId":72228,"journal":{"name":"Annals of nuclear cardiology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Progress of <sup>18</sup>F-flurpiridaz in Clinical Trials\",\"authors\":\"Naoya Matsumoto\",\"doi\":\"10.17996/anc.23-00011\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"18F-flurpiridaz is a novel positron emission computed tomography (PET) tracer in ongoing clinical trials in United States and Japan. A phase III prospective, open-label, multi-center study to assess the feasibility of 18F-flurpiridaz was reported by Maddahi et al. in patients with known or suspected coronary artery disease (CAD) in 2020 in United States (1). 18F-flurpiridaz binds to mitochondrial complex 1 and would distribute to the myocardium with its higher extraction fraction than those in single-photon emission computed tomography (SPECT) tracers (2). In that phase III trial, 795 participants with known or suspected CAD showed that sensitivity of 18F-flurpiridaz PET (for detection of ≥50% stenosis by invasive coronary angiography) was 71.9%, significantly (p < 0.001) higher than 99mTc labeled SPECT agent (53.7%), while specificity did not meet the prespecified noninferiority criterion (76.2% vs. 86.6%, p=NS) (1). Therefore, a second phase III Food and Drug Administration trial was planned and completed by GE Healthcare. Late phase II open-label multicenter study of PET scan using 18F-flurpiridaz (named NMB58 in Japan) to assess myocardial blood flow and diagnostic feasibility in patients with known or suspected CAD started in Japan of 2023.\",\"PeriodicalId\":72228,\"journal\":{\"name\":\"Annals of nuclear cardiology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of nuclear cardiology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.17996/anc.23-00011\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of nuclear cardiology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17996/anc.23-00011","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
18F-flurpiridaz是一种新型的正电子发射计算机断层扫描(PET)示踪剂,目前正在美国和日本进行临床试验。Maddahi等人于2020年在美国报道了一项III期前瞻性、开放标签、多中心研究,以评估18F-flurpiridaz在已知或疑似冠状动脉疾病(CAD)患者中的可行性(1)。与单光子发射计算机断层扫描(SPECT)示踪剂相比,18F-flurpiridaz与线粒体复合物1结合,可分布到心肌(2)。在该III期试验中,795名已知或疑似CAD患者显示,18F-flurpiridaz PET(通过有创冠状动脉造影检测≥50%狭窄)的敏感性为71.9%,显著(p < 0.001)高于99mTc标记的SPECT(53.7%),而特异性不符合预定的非效性标准(76.2% vs. 86.6%, p=NS)(1)。因此,GE Healthcare计划并完成了第二项III期食品和药物管理局试验。2023年,日本开始使用18F-flurpiridaz(日本命名为NMB58)进行PET扫描的晚期II期开放标签多中心研究,以评估已知或疑似CAD患者的心肌血流量和诊断可行性。
Progress of <sup>18</sup>F-flurpiridaz in Clinical Trials
18F-flurpiridaz is a novel positron emission computed tomography (PET) tracer in ongoing clinical trials in United States and Japan. A phase III prospective, open-label, multi-center study to assess the feasibility of 18F-flurpiridaz was reported by Maddahi et al. in patients with known or suspected coronary artery disease (CAD) in 2020 in United States (1). 18F-flurpiridaz binds to mitochondrial complex 1 and would distribute to the myocardium with its higher extraction fraction than those in single-photon emission computed tomography (SPECT) tracers (2). In that phase III trial, 795 participants with known or suspected CAD showed that sensitivity of 18F-flurpiridaz PET (for detection of ≥50% stenosis by invasive coronary angiography) was 71.9%, significantly (p < 0.001) higher than 99mTc labeled SPECT agent (53.7%), while specificity did not meet the prespecified noninferiority criterion (76.2% vs. 86.6%, p=NS) (1). Therefore, a second phase III Food and Drug Administration trial was planned and completed by GE Healthcare. Late phase II open-label multicenter study of PET scan using 18F-flurpiridaz (named NMB58 in Japan) to assess myocardial blood flow and diagnostic feasibility in patients with known or suspected CAD started in Japan of 2023.