PET Detection of CCR2 in Human Atherosclerosis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of 64CU-ECL1i , imaging characteristics
研究概览
简要总结
: Use of novel radio-pharmaceutical 64CUDOTA-ECL1i to evaluate arterial atherosclrosis
详细描述
Using 64CUDOTA-ECL1i to evaluate arterial atherosclrosis in normal volunteers and patients with carotid or femoral arterial atherosclerosis..
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal Volunteers: 18-40 years of age, non smoker, no history of diabetes, hypertension, or hyperlipidemia. Patients: 50-89 years of age, adequate nutritional status, with or without smoking history, diabetes, hypertension, and hyperlipidema. Both asymptomatic and symptomatic patients with known carotid artery atherosclrosis >70% and scheduled to undergo surgery. Advanced peripheral artery disease.
排除标准
- •Inability to receive and sign informed consent. Currently enrolled in another study. Patients who have type 1 diabetes or are in septic shock, receiving steroid therapy, recent history of heavy alcohol consumption, (male >2 drinks per day, and female > 1 drink per day. following extreme diets like Atkins or South Beach diet or with Stage 4 chronic renal failure. Patients with unstable clinical condition that in the opinion of the PI precludes participation in the study. Inability to tolerate 60 minutes in a supine position with arms down at sides. Contraindications to MR imaging, (pacemaker, brain aneurysm clips, shrapnel, etc. Positive pregnancy test or lactating. Have another conditions such as cancer or autoimmune/inflammatory diseases, e.g. rheumatoid arthritis or multiple sclerosis that are known to have increased expression of CCR
研究组 & 干预措施
Aim 1A
Normal volunteers and patients with Carotid and Femoral Atherosclerosis who will be having surgery
干预措施: Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine) (Drug)
Aim 1B
Patients with Carotid and Femoral Atherosclerosis who will be managed medically and not having surgery
干预措施: Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine) (Drug)
结局指标
主要结局
Evaluation of 64CU-ECL1i , imaging characteristics
时间窗: 1 or 2 days
Injecting normal volunteers and patients who have blocked arteries with a single bolus injection. The dose of the injection is 8-10, and the above drug is measured in millicuries, which is a unit of radioactivity. the dose of millicuries will be 8-10 millicures
次要结局
- PET/MR camera, imaging performance(1-2 days)