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.

Start Date15 Feb 2022

Sponsor / Collaborator

Sinotau Pharmaceutical Group

CTR20213067

/ RecruitingPhase 2

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

[Translation] A clinical study to evaluate the efficacy of the new 18F-labeled myocardial perfusion PET imaging agent XTR004 injection in the diagnosis of suspected or known stable coronary heart disease and detection of coronary artery dysfunction

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。

[Translation]

Main objectives: 1) Using coronary angiography as the reference standard, explore the diagnostic efficacy of XTR004 PET myocardial perfusion imaging and myocardial blood flow quantification for coronary heart disease. 2) Using pressure-temperature guidewire FFR/IMR as the reference standard, explore the detection efficacy of XTR004 PET myocardial perfusion imaging and myocardial blood flow quantification for abnormal coronary blood flow reserve function and abnormal coronary microcirculation function. Secondary objectives: To evaluate the safety of subjects with suspected or known stable coronary heart disease after receiving two bolus intravenous injections of XTR004.

Start Date18 Jan 2022

Sponsor / Collaborator

Sinotau Pharmaceutical Group

CTR20210282

/ RecruitingPhase 1

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

[Translation] A single-center, open-label, non-randomized, single-arm Phase I clinical study to evaluate the safety, biodistribution, radiation dose and pharmacokinetics of the novel 18F-labeled myocardial perfusion PET imaging agent XTR004 injection in healthy adults

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。

[Translation]

Primary objective: To evaluate the safety of XTR004 injection after a single intravenous bolus in healthy Chinese adults. Secondary objective: To explore the biodistribution (PET imaging), radiation dose to humans, and pharmacokinetic characteristics of XTR004 injection after a single intravenous bolus in healthy Chinese adults.

Start Date23 Mar 2021

Sponsor / Collaborator

Sinotau Pharmaceutical Group

100 Clinical Results associated with XTR-004

100 Translational Medicine associated with XTR-004

100 Patents (Medical) associated with XTR-004

Literatures (Medical) associated with XTR-004

01 Apr 2024·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

Author: Ren, Chao ; Pan, Qingqing ; 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.

European Journal of Nuclear Medicine and Molecular Imaging

Comparative evaluation of a novel [18F] F-Labeled PET tracer XTR004 against [13N] ammonia in myocardial perfusion imaging for coronary artery disease

Article

Author: Ren, Chao ; Hsu, Bailing ; Wang, Peipei ; Shen, Zhujun ; Wang, Liang ; Li, Fang ; Qian, Hao ; Su, Xinhui ; Huo, Li

AIMSThis study aimed to evaluate image quality, myocardial perfusion, and diagnostic performance of a novel [¹⁸F]F-labeled PET tracer, XTR004 PET, myocardial perfusion imaging (MPI) compared with [¹³N]Ammonia (NH₃) PET MPI.METHODS AND RESULTSForty-seven patients with suspected or known coronary artery disease (CAD) were prospectively enrolled to undergo one-day rest/ATP-stress XTR004 and NH₃ electrocardiograph-gated PET imaging within 2 weeks. Among them, twenty-six patients underwent invasive coronary angiography (ICA), and nineteen were identified with flow-limited CAD (stenosis ≥ 70%). Image quality (excellent/good/average) and certainty of interpretation were evaluated by two independent, blinded readers. Despite a higher liver uptake, XTR004 achieved good to excellent image quality in 83% of cases, comparable to 95.7% of NH₃(P = 0.091). Additionally, the diagnostic certainty, measured as the percentage of cases with definitely abnormal or normal interpretations, was similar between XTR004 and NH₃, with results of 87.2% and 89.2%, respectively. The sensitivity and specificity levels of XTR004 and NH₃ MPI were similar (79% vs. 79%, 86% vs. 71%, P = 1.00). Linear regression of rest/stress myocardial perfusion in 17 segments revealed the linear slope close to unity with excellent R² value (rest: slope = 0.954-1.074, R² = 0.990-0.997; stress: slope = 0.951-1.082, R² = 0.971-0.996). XTR004 was tolerated well by all patients. No adverse events were reported.CONCLUSIONXTR004 PET MPI demonstrated promising image quality, diagnostic certainty and myocardial perfusion characteristics comparable to NH₃ PET MPI. Future research should concentrate on the quantitative analysis of myocardial blood flow to explore the clinical implications of XTR004 PET MPI.

100 Deals associated with XTR-004

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Indication	Highest Phase	Country/Location	Organization	Date
Coronary Artery Disease	Phase 2	CN	Sinotau Pharmaceutical Group	18 Jan 2022

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