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.

项目摘要 EXPLORER系统是一种独特的PET/CT扫描仪，由NIH变革性R 01奖资助建造。 它提供：（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分钟内扫描全身;以及（4）能够 可视化小结构和关节，明显优于当前的PET/CT系统。我们假设 探索者将提供一个特殊的洞察系统性风湿性关节炎（RA）的病理学，并提供 用于全面评估RA疾病活动的定量体内测量（生物标志物） 和治疗反应。 在我们的第一个具体目标中，我们将建立EXPLORER措施与 标准化RA结局指标。在我们的第二个具体目标中，我们将评估EXPLORER的功能 跟踪这些结果指标对RA治疗反应的变化。我们的研究将涉及两个 参与者与RA。第一组的参与者对RA的反应不充分， 生物治疗，并将开始标准治疗RA生物治疗的候选人，除了非 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;开始前 生物治疗开始后3个月。第二组的参与者将有稳定的 疾病，并将选择继续管理他们的RA基于相同的标准护理非生物制剂， 疗法这些受试者将在两个时间点进行扫描，间隔3个月。共有60名与会者（30人 组）将入组研究。 这项工作是创新的，因为新开发的EXPLORER系统的特点， 它的视野，灵敏度和空间分辨率将使新的发现相关的临床和基础 科学研究在RA这项工作是有意义的，因为系统的评估和量化类风湿关节炎疾病 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治疗对关节和其他关键器官的影响， 扫描时间仅需几分钟。最终受益者将是RA患者， 选择范围将扩大，治疗将更加个性化。这项观察性研究非常适合PAR- 18-597，因为它专注于将客观成像生物标志物与已确定的结果测量相关联， RA和地址的重大障碍，在流变学领域的适用性，先进的 在未来的临床研究和临床实践中的PET/CT成像技术。