Imaging Biomarkers of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change From Baseline in T1ρ Relaxation Time
研究概览
简要总结
This study aims to develop, evaluate and translate highly accelerated imaging sequences (each protocol under 5 minutes) for in-vivo knee Osteoarthritis applications on a standard clinical 3T scanner using novel compression sensing and parallel imaging strategies.The overarching objective of the study is to establish a non-invasive imaging biomarker based on the development of rapid relaxation mapping with compressed sensing (CS) that will be clinically useful for assessment of early Osteoarthritis. A total of 90 subjects including 30 patients with high risk of developing knee osteoarthritis (OA), 30 patients with mild OA and 30 healthy controls will be accrued.
详细描述
Current noninvasive imaging methods to evaluate knee joints include plain radiographs, computed tomography (CT), and clinical morphological magnetic resonance imaging (MRI) of joint structures. These techniques can only detect later-stage, macroscopic joint structural abnormalities that are irreversible and not amenable to early therapy. This study aims to develop highly accelerated imaging sequences for ex-vivo knee OA applications on a standard clinical 3T scanner using novel CS and parallel imaging (PI) strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in the HJD OA database, ages 40-75 with high risk of developing OA as defined by:
- •(i) KL score of 0 (ii) Knee pain present in at least 1 knee (iii) Normal radiographs, (iv) At least one abnormal clinical MR finding such as prior knee injury, overweight or traumatic bone marrow edema lesions
- •Patients ages 40-75 with early OA as determined by KL scores 1-2
- •Healthy controls in the HJD OA database (KL score 0, no knee pain, no meniscal or ligament tears)
排除标准
- •Contraindications for MRIs (e.g. pacemakers, ferromagnetic vascular clips, metal implants, claustrophobia, etc).
- •Subjects with any joint disease (example: Rheumatoid or inflammatory arthritis) other than knee OA, corticosteroid injections within the previous 3 months, and history of avascular necrosis, Paget's disease of bone, Wilson's disease, gout, total knee replacement (or plan for replacement within next 24 months).
- •Major co-morbidities such as diabetes, mellitus, cancer, congestive heart failure and chronic infectious diseases.
- •Alignment interventions such as insoles and knee braces
- •Vulnerable patients will not be recruited for this study
结局指标
主要结局
Change From Baseline in T1ρ Relaxation Time
时间窗: Baseline, Month 24
MRI exam of accelerated 3D-T1p conducted on whole knee joint specimens to determine cartilage composition, measured as T1ρ relaxation time. T1ρ MRI relaxation times refer to the proteoglycan density within cartilage. Images taken at baseline and at Month 24.
Change From Baseline in T2 Relaxation Time
时间窗: Baseline, Month 24
MRI exam of accelerated T2 conducted on whole knee joint specimens to determine cartilage composition, measured as T2 relaxation time. T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. Images taken at baseline and at Month 24.
次要结局
- Change From Baseline in Western Ontario and McMaster University OA Index (WOMAC) Score(Baseline, Month 24)
- Change From Baseline in Knee Injury and OA Outcomes Score (KOOS)(Baseline, Month 24)
- Change From Baseline in Physical Activity Scale for the Elderly (PASE) Scores(Baseline, 24 Months)