Study of 99mTc-EC20 Imaging (FolateScan) in Participants With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Frequency of knee uptake of 99mTc-EC20
研究概览
简要总结
The purpose of this study is to evaluate 99mTc - EC20 imaging (FolateScan), a Nuclear Medicine imaging technology that enables localization of activated macrophages in the joints of participants with knee osteoarthritis (OA). Twenty five participants with symptomatic unilateral or bilateral knee OA will undergo a one-time evaluation of the knee as follows: knee radiography, FolateScan of the knees and whole body, musculoskeletal exam, questionnaires, sampling of blood, urine and synovial fluid for analysis of inflammatory markers. Data analysis will be cross-sectional and include a comparison of the location and intensity of EC20 uptake with the following: radiographic knee OA severity, clinical measures of disease severity, cytokine expression, and synovial fluid cell count.
详细描述
Each study day will on average last one day per individual and each individual will be followed for development of an Adverse Event for 7 days
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral or bilateral knee OA; Kellgren Lawrence grade 1-4; Knee pain on most days of any one-month in the last year in at least one knee; Age > 18 years old.
排除标准
- •Arthroscopic knee surgery within the previous 12 months; Intra-articular injection or systemic (oral, IV, IM) steroid within previous 6 months; Any knee replacement; Current enrollment in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug used in this study); Pregnancy; Positive serum beta HCG within 48 hours prior to 99mTc-EC20 administration and/or lactation; Rheumatoid arthritis or other inflammatory arthropathy; Avascular necrosis; Periarticular fracture; Current anticoagulant therapy; Current immune modulator therapy, or any such therapy within 4 weeks of study procedures; Inability to discontinue use of NSAIDS within 3 days of study procedures (low dose aspirin of up to 325 mg per day is permitted); Must be able to stop Folic Acid containing vitamins 24 hrs before study; Paget's disease; Villonodular synovitis; Joint infection; Ochronosis; Neuropathic arthropathy; Acromegaly; Hemochromatosis; Wilson's disease; Osteochondromatosis; Personnel directly affiliated with this study or their immediate family members; Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
研究组 & 干预措施
Knee Osteoarthritis
Unilateral or bilateral knee osteoarthritis on radiograph associated with knee pain on most days of any one-month in the last year in at least one knee.
Study participants underwent a one-time evaluation by FolateScan which entailed a single intravenous injection of 99mTc-EC20 (total volume of 1.0 to 2.0 ml administered over a period of 30 seconds with radioactive dose between 20 and 25 mCi).
干预措施: 99mTc-EC20 (Drug)
结局指标
主要结局
Frequency of knee uptake of 99mTc-EC20
时间窗: Baseline
These data will be collected at a single timepoint (baseline) only and participants will not be further followed.
次要结局
- Correlation of knee symptoms and knee uptake of 99mTc-EC20(Baseline)
- Intensity and location of uptake of 99mTc-EC20(Baseline)
- Correlation of 99mTc-EC20 uptake and biomarkers(Baseline)
- Correlation of knee radiographic OA and knee uptake of 99mTc-EC20(Baseline)
研究者
Virginia Kraus
Professor
Duke University