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; 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 通过NIH Transformative R01奖通过资金构建的Explorer系统是独特的宠物/CT扫描仪 提供：（1）一个轴向视野，一枪覆盖整个成年人的身体； （ii）明显的辐射 与当前的PET/CT方案相比，减少剂量； （3）在1分钟内扫描整个身体； （4）能力 可视化的小结构和关节明显好于当前的PET/CT系统。我们假设 该探险家将提供对系统性类风湿关节炎（RA）病理学的特殊见解，并提供 定量，体内措施（生物标志物），以便对RA疾病活动进行全面评估 和治疗反应。 在我们的第一个特定目标中，我们将建立探险家措施与 标准化的RA成果指标。在我们的第二个特定目标中，我们将评估探险家的功能 通过响应RA治疗来追踪这些结果度量的变化的措施。我们的研究将涉及两个 RA参与者组。第一组的参与者将对RA非 - 生物疗法，除非非 - 生物疗法。这些参与者将在两个时间点上扫描Explorer系统。开始之前 生物疗法和开始生物疗法后3个月。第二组的参与者将保持稳定 疾病，并将根据相同的标准非生物学选择继续管理其RA 治疗。这些参与者将在相隔3个月的两个时间点进行扫描。共有60名参与者（每位30位参与者 小组）将参加该研究。 这项工作具有创新性，因为用术语的新开发的探险家系统的特征 在其视野中，灵敏度和空间分辨率将使与临床和基本的新发现相关 RA科学研究。这项工作很重要，因为全身评估和对RA疾病的量化 基于探险家的总体和低剂量PET/CT成像功能的活动可以改善 风险分层和精确监测RA处理对关节的影响以及其他关键器官 扫描时间仅几分钟。最终受益人将是RA患者作为治疗 选项将扩大，治疗将变得更加个性化。这项观察性研究非常适合 18-597，因为它重点是将客观成像生物标志物与已建立的结果度量相关联 RA并解决了风湿病领域中有关高级适用性的重大障碍 未来的临床研究和临床实践中的成像技术（PET/CT）。