Phase I Study to Evaluated the Safety of Noninvasive Molecular Imaging for the Detection of Inflammation in Carotid Atherosclerotic Lesions by Using Ga-68-NOTA-MSA in Healthy Volunteers and Patients With Coronary Artery Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- side reactions at MSA injection site of the skin
研究概览
简要总结
Until now, no specific atherosclerosis-targeting agent labeled with positron emitter is not yet available. Investigators developed neomannosyl human serum albumin(MSA) for the terminal mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis, and investigators investigate whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of carotid atherosclerotic lesion in PET.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- ••coronary artery disease patients with carotid plaques
- •control without carotid plaque
排除标准
- ••pregnancy, allergy to albumin, any acute or chronic inflammatory disease, hematologic disease, liver disease, renal disease
研究组 & 干预措施
Atherosclerosis
coronary artery disease patients with carotid plaques confirmed by a ultrasound study
干预措施: 68Gallium-MSA (Other)
control
no coronary artery disease patients without carotid plaques confirmed by a ultrasound study
干预措施: 68Gallium-MSA (Other)
结局指标
主要结局
side reactions at MSA injection site of the skin
时间窗: with 2 hours after MSA injection
development of unexpected skin rashes or other skin lesions at MSA injection site of the skin with 2 hours after MSA injection
unstable changes of vital signs and development of abnormal biochemical parameters
时间窗: 24 hours after MSA injection
This includes unstable changes of vital signs including blood pressure, body temperature and heart rate, and abnormal changes of biochemical parameters such as hematologic, hepatic and renal functions.
次要结局
- standard uptake unit(SUV) at carotid arteries(baseline)
- SUV at aorta and iliac arteries(baseline)
研究者
Hong Seog Seo
Professor of Medicine
Korea University