Aims

This 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 results

Forty-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.

Conclusion

XTR004 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.

Graphical Abstract

中文翻译：

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新型 [18F] F 标记 PET 示踪剂 XTR004 与 [13N] 氨在冠状动脉疾病心肌灌注成像中的比较评价

 目标

本研究旨在评估新型 [¹⁸F]F 标记的 PET 示踪剂 XTR004 PET、心肌灌注成像 （MPI） 与 [¹³N] 氨 （NH₃） PET MPI 相比的图像质量、心肌灌注和诊断性能。

 方法和结果

前瞻性纳入 47 例疑似或已知冠状动脉疾病 （CAD） 患者，在 2 周内接受 1 天休息/ATP 应激 XTR004 和 NH₃ 心电图门控 PET 成像。其中 26 例患者接受了有创冠状动脉造影 （ICA），19 例被确定为血流受限型 CAD （狭窄≥ 70%）。图像质量 （优秀/良好/一般） 和解释质量由两名独立的盲法读者评估。尽管肝脏摄取较高，但 XTR004 在 83% 的病例中实现了良好至极好的图像质量，与 NH₃ 的 95.7% 相当 （P = 0.091）。此外，XTR004 和 NH₃ 之间的诊断质量（以明确异常或正常解释的病例百分比衡量）相似，结果分别为 87.2% 和 89.2%。XTR004 和 NH₃ MPI 的敏感性和特异性水平相似 （79% vs. 79%，86% vs. 71%，P = 1.00）。17 个节段中静息/负荷心肌灌注的线性回归显示线性斜率接近统一，具有优异的 R² 值（静息：斜率 = 0.954–1.074，R² = 0.990–0.997;应力：斜率 = 0.951–1.082，R² = 0.971–0.996）。XTR004 所有患者均耐受良好。未报告不良事件。

 结论

XTR004 PET MPI 表现出与 NH₃ PET MPI 相当的良好图像质量、诊断确定性和心肌灌注特性。未来的研究应集中在心肌血流的定量分析上，以探索 XTR004 PET MPI 的临床意义。

 图形摘要