The Journal of Nuclear Medicine ( IF 9.1 ) Pub Date : 2025-01-01 , DOI: 10.2967/jnumed.124.267869 Robert J.H. Miller, Krishna K. Patel, Jacek Kwiecinski, Leandro Slipczuk, Marc Dweck, David E. Newby, Panithaya Chareonthaitawee, Piotr Slomka
Nuclear cardiology offers a diverse range of imaging tools that provide valuable insights into myocardial perfusion, inflammation, metabolism, neuroregulation, thrombosis, and microcalcification. These techniques are crucial not only for diagnosing and managing cardiovascular conditions but also for gaining pathophysiologic insights. Surrogate biomarkers in nuclear cardiology, represented by detectable imaging changes, correlate with disease processes or therapeutic responses and can serve as endpoints in clinical trials when they demonstrate a clear link with these processes. By providing early indicators of therapeutic efficacy—often before clinical outcomes manifest—surrogate biomarkers can accelerate treatment development. This disease-focused review will highlight key nuclear cardiology surrogate biomarkers, emphasizing the importance of standardized imaging protocols and robust quantitative techniques to ensure accuracy and reproducibility. We will also explore the challenges to the broader adoption of imaging biomarkers, including the need for well-defined pathophysiologic correlations, greater data diversity in clinical research, and overcoming regulatory barriers. Addressing these challenges will improve the utility of imaging biomarkers in clinical trials, enabling more precise cardiovascular care through early diagnosis and therapeutic monitoring, ultimately accelerating the development of novel cardiovascular therapies.
中文翻译:
临床试验中的核心脏病学替代生物标志物
核心脏病学提供了多种成像工具,为心肌灌注、炎症、代谢、神经调节、血栓形成和微钙化提供了有价值的见解。这些技术不仅对于诊断和管理心血管疾病至关重要,而且对于获得病理生理学见解也至关重要。核心脏病学中的替代生物标志物,以可检测的影像学变化为代表,与疾病过程或治疗反应相关,当它们证明与这些过程有明确联系时,可以作为临床试验的终点。通过提供治疗效果的早期指标(通常在临床结果出现之前),替代生物标志物可以加速治疗开发。本篇以疾病为重点的综述将重点介绍关键的核心脏病学替代生物标志物,强调标准化成像方案和稳健的定量技术对确保准确性和可重复性的重要性。我们还将探讨更广泛采用成像生物标志物的挑战,包括需要明确的病理生理相关性、临床研究中更大的数据多样性以及克服监管障碍。应对这些挑战将提高成像生物标志物在临床试验中的实用性,通过早期诊断和治疗监测实现更精确的心血管护理,最终加速新型心血管疗法的开发。