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

全身 PET/CT 用于评估类风湿性关节炎疾病活动性和治疗反应

• 批准号: 9817105
• 负责人: Abhijit J Chaudhari
• 金额: $ 24.18万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9817105
• 关键词: Address; Adult; Aftercare; Award; Basic Science; Beds; Biological Markers; Biological Response Modifier Therapy; Characteristics; Clinical; Clinical Research; Clinical Sciences; Comorbidity; Data; Detection; Disease; Dose; Emission-Computed Tomography; Enrollment; Evaluation; Funding; Future; Goals; Grant; Health Status; Heart failure; Human; Human body; Image; Imaging Techniques; Impaired health; Individual; Inflammation; Inflammatory; Inflammatory Arthritis; Intervention Trial; Ionizing radiation; Joints; Measures; Molecular; Monitor; National Institute of Arthritis and Musculoskeletal and Skin Diseases; Observational Study; Organ; Outcome Measure; Participant; Pathology; Patients; Physicians; Positioning Attribute; Positron-Emission Tomography; Protocols documentation; Radiation Dose Unit; Radiation exposure; Reproducibility; Research; Research Design; Resolution; Rheumatoid Arthritis; Rheumatology; Risk; Risk stratification; Sample Size; Scanning; Stable Disease; Standardization; Structure; Surrogate Endpoint; Synovial Membrane; Synovitis; System; Technology; Testing; Therapeutic; Time; Tissues; Tomography, Computed, Scanners; Treatment Protocols; United States National Institutes of Health; Work; X-Ray Computed Tomography; base; beneficiary; clinical practice; fluorodeoxyglucose; functional disability; glucose metabolism; imaging biomarker; imaging capabilities; improved; in vivo; innovation; insight; joint destruction; optimal treatments; preclinical study; radiotracer; response; side effect; standard of care; treatment response; whole body imaging

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.

项目概要 EXPLORER 系统是由 NIH 变革性 R01 奖资助建造的，是一款独特的 PET/CT 扫描仪 它提供：（1）一次覆盖整个成人人体的轴向视野； (二) 大量辐射 与当前 PET/CT 方案相比，剂量减少； (3) 1分钟内完成全身扫描； (4) 能力 显着优于当前 PET/CT 系统的小型结构和关节可视化。我们假设 EXPLORER 将提供对系统性类风湿关节炎 (RA) 病理学的独特见解，并提供 用于全面评估 RA 疾病活动性的定量体内测量（生物标志物） 和治疗反应。 在我们的第一个具体目标中，我们将在 EXPLORER 措施与 标准化 RA 结果测量。在我们的第二个具体目标中，我们将评估 EXPLORER 的能力 跟踪这些结果指标因 RA 治疗而发生的变化。我们的研究将涉及两个 患有 RA 的参与者组。第一组的参与者对 RA 非-反应不充分 生物治疗，并将成为除非治疗外，开始标准护理 RA 生物治疗的候选者 生物疗法。这些参与者将在两个时间点在 EXPLORER 系统上进行扫描；开始之前 生物治疗以及开始生物治疗后 3 个月。第二组的参赛者将拥有稳定的 疾病，并将选择继续根据相同的非生物治疗标准来管理他们的 RA 治疗。这些参与者将在两个时间点接受扫描，相隔 3 个月。参加人数 60 人（每人 30 人） 组）将被纳入该研究。 这项工作具有创新性，因为新开发的 EXPLORER 系统在方面的特点 其视野、灵敏度和空间分辨率的改进将使与临床和基础相关的新发现成为可能 RA 的科学研究。这项工作意义重大，因为 RA 疾病的系统评估和量化 基于 EXPLORER 的全身和低剂量 PET/CT 成像能力的活动可以改善 风险分层和精确监测 RA 治疗对关节和其他重要器官的影响 身体，扫描时间仅需几分钟。最终受益者将是 RA 患者 选择范围将会扩大，治疗也将更加个性化。这项观察性研究非常适合 PAR- 18-597，因为它侧重于将客观成像生物标志物与已建立的结果测量相关联 RA 并解决了风湿病领域有关先进技术适用性的重大障碍 成像技术（PET/CT）在未来的临床研究和临床实践中的应用。