Evaluation of XTR004 as a Novel 18F-labeled PET Myocardial Perfusion Imaging (MPI) Tracer in Diagnosis of Known or Suspected CAD Compared With Invasive Coronary Angiography, Fractional Flow Reserve, Index of Microcirculatory Resistance

The diagnostic efficacy and safety of the XTR004 myocardial perfusion PET imaging tracer are evaluated for known or suspected CAD with the use of invasive coronary angiography as the reference standard for the diagnosis of CAD and invasive pressure-temperature FFR/IMR as a reference for the detection of abnormal coronary function.

开始日期2022-02-15

申办/合作机构

北京先通国际医药科技股份有限公司

CTR20213067 / Recruiting临床2期

评估新型18F标记心肌灌注PET显像剂XTR004注射液对于可疑或已知稳定性冠心病诊断及冠脉功能异常检测效能的临床研究

主要目的：1）以冠脉造影为参考标准，探索XTR004 PET心肌灌注显像及心肌血流定量对于冠心病的诊断效能。2）以压力-温度导丝FFR/IMR为参考标准，探索XTR004 PET心肌灌注显像及心肌血流定量对于冠脉血流储备功能异常及冠脉微循环功能异常的检测效能。次要目的：评估可疑或已知稳定性冠心病受试者接受两次弹丸式静脉给予XTR004注射液后人体的安全性。

开始日期2022-01-18

申办/合作机构

北京先通国际医药科技股份有限公司

CTR20210282 / Recruiting临床1期

评估新型18F-标记心肌灌注 PET 显像剂 XTR004 注射液在健康成年人中的安全性、生物分布、辐射剂量及药代动力学单中心、开放、非随机、单臂 I 期临床研究

主要目的：评估中国健康成年人接受单次弹丸式静脉给予 XTR004 注射液后人体的安全性。次要目的：探讨中国健康成年人接受 XTR004 注射液单次弹丸式静脉给药后的（PET 显像）生物分布、对人体的辐射剂量、在人体内的药代动力学特征。

开始日期2021-03-23

申办/合作机构

北京先通国际医药科技股份有限公司

100 项与 XTR-004 相关的临床结果

登录后查看更多信息

100 项与 XTR-004 相关的转化医学

登录后查看更多信息

100 项与 XTR-004 相关的专利（医药）

登录后查看更多信息

项与 XTR-004 相关的文献（医药）

2024-04-01·Journal of Nuclear Cardiology

Phase I, first-in-human study of XTR004, a novel 18F-labeled tracer for myocardial perfusion PET: Biodistribution, radiation dosimetry, pharmacokinetics, and safety after a single injection at rest

Article

作者: Pan, Qingqing ; Ren, Chao ; Fu, Chao ; Wang, Peipei ; Hsu, Bailing ; Huo, Li ; Zheng, Zhiquan

OBJECTIVESThis study assessed the imaging characteristics, pharmacokinetics and safety of XTR004, a novel ¹⁸F-labeled Positron Emission Tomography (PET) myocardial perfusion imaging tracer, after a single injection at rest in humans.METHODSEleven healthy subjects (eight men and three women) received intravenous XTR004 (239-290 megabecquerel [MBq]). Safety profiles were monitored on the dosing day and three follow-up visits. Multiple whole-body PET scans were conducted over 4.7 h to evaluate biodistribution and radiation dosimetry. Blood and urine samples collected for 7.25 h were metabolically corrected to characterize pharmacokinetics.RESULTSIn the first 0-12 min PET images of ten subjects, liver (26.81 ± 4.01), kidney (11.43 ± 2.49), lung (6.75 ± 1.76), myocardium (4.72 ± 0.67) and spleen (3.1 ± 0.84) exhibited the highest percentage of the injected dose (%ID). Myocardial uptake of XTR004 in the myocardium initially reached 4.72 %ID and 7.06 g/mL, and negligibly changed within an hour (Δ: 7.20%, 5.95%). The metabolically corrected plasma peaked at 2.5 min (0.0013896 %ID/g) and halved at 45.2 min. Whole-body effective dose was 0.0165 millisievert (mSv)/MBq. Cumulative urine excretion was 8.18%. Treatment-related adverse events occurred in seven out of eleven subjects (63.6%), but no severe adverse event was reported.CONCLUSIONSXTR004 demonstrated a favorable safety profile, rapid, high, and stable myocardial uptake and excellent potential for PET myocardial perfusion imaging (MPI). Further exploration of XTR004 PET MPI for detecting myocardial ischemia is warranted.

100 项与 XTR-004 相关的药物交易

登录后查看更多信息