Novel Quantitative MRI for Axial Spondyloarthritis
关键词
抽象
描述
There is a critical and unmet clinical need for non-invasive techniques that provide early diagnosis as well as reliable and sensitive evaluations of ongoing disease activity and treatment response in patients with axial spondyloarthritis (axSpA). Imaging plays a key role to fulfill this goal and there is an increasing trend of applying imaging techniques in the field of axSpA. However, current imaging techniques, including radiographs and MRI, are primarily limited to qualitative or semi-quantitative evaluations of disease activity and structural damage, which is very crude and subjective with considerable inter-reader variation, and has limited sensitivity of detecting early lesions as well as changes in inflammatory lesions beyond morphology of bone marrow edema after treatment. Furthermore, several recent studies reported data of inflammation (bone marrow edema), fatty deposition and new bone formation after TNF inhibitor (TNFi) treatment in patients with axSpA, suggesting a complex relationship between inflammation, bone formation, and suppression of the TNF pathway. These studies also call for differentiating edema for their characteristics (angiogenesis for example) and inflammation stages (acute and chronic), which will provide valuable insight on disease pathophysiology as well as on optimizing treatment for individual patients with axSpA.
The long-term goal is to develop novel quantitative MRI measures that will reliably assess both inflammation and structural damage, and predict treatment response, remission and disease progression in axSpA. Compared to current MRI grading systems, such quantitative measures may be used as more sensitive, specific, reliable and faster imaging markers for future trials, and eventually for clinical practice to improve patient management in axSpA. In this proposal, Investigators will focus on patients with clinically diagnosed active Ankylosing Spondylitis (AS) and will develop novel imaging and image processing techniques using 3 Tesla MRI. The specific aims are two-folds. Firstly, Investigators will develop methods that reliably quantify bone marrow edema (BME), fatty deposition (FD) and erosions; Secondly, Investigators will develop novel quantitative evaluation of perfusion and vascularity of BME (using dynamic Gd-enhanced MRI), which has not been investigated for axSpA in the literature.
Investigators will recruit 20 patients with active Ankylosing Spondylitis (AS) using the 1984 modified NY criteria. Fifteen patients will be recruited from the Ankylosing Spondylitis clinic at UCSF, directed by Dr. Lianne Gensler, and five patients will be recruited from Rheumatology clinic at the Cleveland Clinic by Dr. Elaine Husni. Drs. Gensler and Husni will also reach out to the other academic sites and the community private practices to recruit patients as needed who are starting TNF inhibitor therapy with CZP for their AS. Patients will be studied at baseline, 4-weeks and 48-weeks after initiation of TNFi treatment. Advanced quantitative MRI will be applied to evaluate early treatment response at 4-weeks, and long-term outcomes at 48-weeks. The central hypothesis is that quantitative MRI allows a fast, specific and reproducible evaluation of disease activity and structural changes in AS, and provides more superior diagnostic and prognostic capability compared to semi-quantitative MRI grading systems.
The successful implementation of the proposed study will make significant contributions to the research and clinical
日期
| 最后验证: | 03/31/2019 |
| 首次提交: | 11/26/2018 |
| 提交的预估入学人数: | 12/13/2018 |
| 首次发布: | 12/18/2018 |
| 上次提交的更新: | 04/08/2019 |
| 最近更新发布: | 04/10/2019 |
| 实际学习开始日期: | 03/31/2019 |
| 预计主要完成日期: | 11/30/2020 |
| 预计完成日期: | 05/31/2021 |
状况或疾病
干预/治疗
Diagnostic Test: MRI
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Cases - Ankylosing Spondylitis Cohort 20 patients with ankylosing spondylitis (AS). Fifteen of these patients will be recruited from the Ankylosing Spondylitis clinic at the University of California, San Francisco. Five patients will be recruited from the Rheumatology clinic at the Cleveland Clinic. Observational with MRI. | |
| Controls - w/o Ankylosing Spondylitis 5 patients without AS and with no history of any arthritis or lower back pain in this study. These 5 patients will make up the control group of the study, which means that they will provide a benchmark of comparison for the results investigators obtain from the active AS group. 2 of these 5 patients will be recruited from Cleveland Clinic, and 3 will be recruited from UCSF. Observational with MRI |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Active AS meeting the modified New York criteria - BASDAI ≥ 4 - Elevated C-Reactive Protein - ≥ 18 years old - Initiation of TNFi treatment with CZP Exclusion Criteria: - Previous treatment with more than one biologics - Biologic treatment within six-months (no more than 20% of group (n=4) for patients with previous biologic treatment) - Non-response to previous anti TNF treatment - Fibromyalgia or other reasons for back pain - Pregnant patients - Patients on > 10mg of Prednisone per day |
结果
主要结果指标
1. Change in Volume of MRI bone marrow edema (in cm^3) from Baseline at 48-weeks [Change from Baseline at 48-weeks]
2. Change in MRI grading SPARCC from Baseline at 48-weeks [Change from Baseline at 48-weeks]
次要成果指标
1. Change in C-reactive protein (CRP) (in mg/dL) from Baseline at 48-weeks [Change from Baseline at 48-weeks]
2. Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP at Baseline, 4-weeks, 48-weeks [Change from Baseline at 48-weeks]
