Total-Body PET/CT for assessing Rheumatoid Arthritis Disease Activity and Treatment Response

项目摘要 探索者系统由NIH Transformative R01奖资助建造，是一种独特的PET/CT扫描仪 这提供了：(1)一次拍摄覆盖整个成人人体的轴向视野；(Ii)显著的辐射 与目前的PET/CT方案相比，剂量减少；(3)在1分钟内完成全身扫描；以及(4)能力 可视化小结构和关节，这比目前的PET/CT系统要好得多。我们假设 该探索者将提供对系统性类风湿性关节炎(RA)病理的特殊洞察，并提供 用于全面评估RA疾病活动性的定量活体测量(生物标记物) 和治疗反应。 在我们的第一个具体目标中，我们将建立探索者措施与 标准化的RA结果衡量标准。在我们的第二个具体目标中，我们将评估探索者的能力 跟踪这些结果指标在RA治疗中的变化的措施。我们的研究将涉及两个 患有类风湿性关节炎的参与者分组。第一组参与者对非RA的反应不充分 生物疗法，将成为启动标准护理类风湿性关节炎生物疗法的候选对象 生物疗法。这些参与者将在两个时间点在资源管理器系统上进行扫描；在开始之前 生物治疗，开始生物治疗3个月。第二组的参与者将拥有稳定的 疾病，并将选择继续基于相同的非生物护理标准来管理其RA 心理治疗。这些参与者将在相隔3个月的两个时间点接受扫描。共有60名参与者(30% 组)将加入这项研究。 这项工作具有创新性，因为新开发的浏览器系统在 它的视野、灵敏度和空间分辨率将使新的发现与临床和基础研究相关 RA的科学研究。这项工作具有重要意义，因为对RA疾病进行了系统的评估和量化 基于全身的活动和探索者的低剂量PET/CT成像能力可以提高 对RA治疗对关节和其他重要器官的影响进行风险分层和精确监测 身体，扫描时间只有几分钟。最终的受益者将是类风湿关节炎患者，作为他们的治疗者 选择将会扩大，治疗将更加个性化。这项观察性研究非常适合于PAR- 18-597，因为它专注于将客观的成像生物标记物与已建立的结果测量相关联 RA，并解决了风湿学领域中关于先进的 影像技术(PET/CT)在未来的临床研究和临床实践中的应用。

Project Summary The EXPLORER system, built via funding from an NIH transformative R01 award, is a unique PET/CT scanner that offers: (1) an axial field of view that covers the whole adult human body in one shot; (ii) significant radiation dose reduction compared to current PET/CT protocols; (3) scans of the entire body in under 1 min; and (4) ability to visualize small structure and joints that is significantly better than current PET/CT systems. We hypothesize that EXPLORER will offer an exceptional insight into systemic Rheumatoid Arthritis (RA) pathology and provide quantitative, in vivo measures (biomarkers) for enabling a comprehensive assessment of RA disease activity and treatment response. In our first specific aim, we will establish the association between EXPLORER measures with standardized RA outcome measures. In our second specific aim, we will evaluate the capabilities of EXPLORER measures to track changes in these outcome measures in response to RA treatment. Our study will involve two groups of participants with RA. Participants in the first group will have had an inadequate response to RA non- biologic therapy and will be candidates for starting standard-of-care RA biologic therapy in addition to non- biologic therapy. These participants will be scanned on the EXPLORER system at two time points; before starting biologic therapy and 3 months after starting biologic therapy. Participants in the second group will have stable disease and will have chosen to continue to manage their RA based on the same standard-of-care non-biologic therapy. These participants will be scanned at two time points, 3 months apart. A total of 60 participants (30 per group) will be enrolled in the study. This work is innovative because the characteristics of the newly-developed EXPLORER system in terms of its field-of-view, sensitivity and spatial resolution would enable new findings relevant to both clinical and basic science research in RA. This work is significant because systemic assessment and quantification of RA disease activity based on total-body and low-dose PET/CT imaging capabilities of EXPLORER could enable improved risk stratification and precise monitoring of the effects of RA treatments on joints, and other crucial organs across the body, with scan times of just a few minutes. The ultimate beneficiaries will be RA patients as their therapeutic options will widen and treatments will be more personalized. This observational study is well-suited for the PAR- 18-597 because it focuses on associating objective imaging biomarkers with established outcome measures of RA and addresses significant obstacles in the rheumatology field regarding the applicability of an advanced imaging technique (PET/CT) in future clinical studies and clinical practice.