Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Demonstrate lumisight fluorescence activity in lumisight cohort vs controls
研究概览
简要总结
Active inflammation plays a key role in causing Coronary Artery Disease (CAD) and Peripheral Arterial Disease (PAD). Since inflammation is so important in how these diseases start, are diagnosed, and treated, being able to see it clearly in each patient could lead to more personalized and effective care - and may help prevent heart attacks. Right now, there's no imaging technology available to clearly see inflammation inside the coronary arteries.
The investigators hope to learn how an imaging drug; called LUMISIGHT (Pegulicianine) can help detect inflammation in blood vessels compared with saline. If the investigators find out that LUMISIGHT is active in humans, the investigators might be able to use it for detecting plaque risk in the future.
详细描述
Objective of this research is to find out if a new imaging drug called LUMISIGHT can show inflammation inside blood vessels for participants with severe coronary and peripheral arterial disease. This will allow us to obtain information about diseases that cause inflammation in the heart and blood vessels.
On the day of the procedure, at least 2 hours before the surgery, consented study participants will be injected with either the LUMISIGHT or saline. Following the injection, study participants will be monitored and observed for 30 minutes for any allergic reactions. Study participants will then undergo the standard of care surgery for their clinical care. During the procedure, surgeon will take out blocked pieces of subjects' blood vessel for clinical care. The investigators will get these discarded pieces and image it with a special imaging system developed by the Tearney Lab. This system uses a thin tube with a light-based camera (called Optical Coherence Tomography-Near Infra Red Fluorescence or OCT-NIRF) to capture detailed images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Must have an established diagnosis of severe carotid or peripheral arterial disease (ischemic or aneurysmal) requiring surgery and be sufficiently healthy to undergo surgery
- •Must be age of 18 years or older
- •Must be able to give informed consent
- •Women with childbearing potential must have a negative pregnancy test
- •Estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2 (mild renal impairment
排除标准
- •History of allergic reaction to oral or intravenous contrast agents
- •History of allergic reaction to polyethylene glycol (PEG)
- •History of allergic or anaphylactic reactions
- •Participants who have taken an investigational drug within 14 days of enrollment.
- •Participants with hemodynamic instability
- •Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) <60ml/min/1.73 m2)
- •Pregnant or lactating females
- •Participants with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy
- •Severe concurrent illnesses including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
Normal Saline
Five(5) participants will receive saline injections and be considered controls
干预措施: Placebo (Other)
PEGULICIANINE (LUMISIGHT)
Twenty (20) participants will receive 1.0 mg/kg of LUMISIGHT
干预措施: Pegulicianine (Drug)
结局指标
主要结局
Demonstrate lumisight fluorescence activity in lumisight cohort vs controls
时间窗: 2-6 hours
Mean difference in plaque for fluorescence ratio to show that fluorescence in the Lumisight cohort is 2 fold greater than that of the control
次要结局
未报告次要终点
研究者
Guillermo Tearney
Principal Investigator
Massachusetts General Hospital