{"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}
引用次数: 0
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.