IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Compare metabolic activity
研究概览
简要总结
Several clinical trials on genicular artery embolization (GAE) show significant clinical benefit for the majority of patients. However, a proportion of patients do not benefit from GAE, and responses vary across individual patients. Changes in metabolic activity on non-invasive imaging may correlate with improvement in symptoms of knee osteoarthritis. This study will assess changes in metabolic uptake on a hybrid positron emission tomography/magnetic resonance imaging (PET/MRI) system in subjects undergoing GAE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided informed consent
- •Age ≥ 40 years
- •Ineligibility for or refusal of surgical management
- •Moderate-severe knee pain as determined by visual analog scale > 5 out of 10
- •Osteoarthritis based on X-ray. Kellgren-Lawrence score > 2 based on radiograph completed within 3 months of procedure date
- •Resistant/failed some form of conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection/hyaluronic acid joint injection) for at least 3 months
- •Able to comply with all treatments and protocol follow-up visits
排除标准
- •Mild knee pain as determined by visual analog scale < 5 out of 10
- •OA on knee radiograph resulting in greater than 20 degree varus or valgus angulation
- •Moderate loss of kidney function, define as estimated glomerular filtration rate of less than 45 mL/min.
- •Significant arterial atherosclerosis that would limit selective angiography
- •History of fibromyalgia, autoimmune, or inflammatory disorder
- •History of any lumbar spine surgery, spine injections, or radicular pain in the extremity believed to originate from the spine
- •Allergy to iodinated contrast agents
- •Active infection or malignancy
- •Recent (within 12 months) or active cigarette use
- •Prior total or partial knee replacement in the subject knee
- •Active pregnancy
- •Uncorrectable bleeding diathesis
- •Presence of pacemakers, aneurysm clips, neurostimulators, or any other metal implant not compatible with PET/MRI
结局指标
主要结局
Compare metabolic activity
时间窗: Screening, Month 6
To compare change in metabolic activity detected by PET/MRI as defined as percentage change in maximum standardized uptake value (SUVmax) and incidence of clinical response in patients undergoing GAE as defined as a 50% reduction in Western Ontario and McMaster Universities Arthritis Index (WOMAC).
次要结局
- Associate changes in metabolic activity detected by PET(Screening, Month 6)
- Assess osseous metabolic abnormalities correlation with osseous abnormalities and cartilage degeneration(Screening, Month 6)
- Safety of GAE(Treatment, Month 3, Month 6, Month 12)
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Treatment Efficacy(Screen, Month 3, Month 6, Month 12)
- Change From Baseline in Visual Analog Scale (VAS) as a Measure of Treatment Efficacy(Screen, Month 3, Month 6, Month 12)
- Assess KOOS5(Screen, Month 3, Month 6, Month 12)
研究者
Lucas R. Cusumano, MD
Interventional Radiologist, Assistant Clinical Professor
University of California, Los Angeles