An Exploratory, Phase II, Open Label, Single-Center, Non-Randomized Study Of [F-18] RGD-K5 Positron Emission Tomography (PET) In Participants With Carotid Artery Stenosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Uptake of [F-18] RGD-K5 by Carotid Plaque With PET/MRI Imaging in the Artery Believed to be the Cause of Transient Ischemic Attack (TIA) or Stroke Symptoms Compared to the Contralateral Carotid Artery Not Implicated in TIA or Stroke
研究概览
简要总结
The purpose of this study is to investigate the ability of a new investigational agent compound [F-18] labeled RGD-K5 to detect unstable atherosclerotic plaque in the carotid artery of subjects being considered for carotid endarterectomy (CEA), and to confirm this ability through tissue analysis of samples of carotid artery plaques that will be collected during the planned carotid surgery. [F-18] RGD-K5 is a radioactive tracer used in imaging to detect active growth of new blood vessels and presence of macrophages. Patients with unstable plaque may be prone to rupture of the plaque due to increase in macrophage activity and growth of new blood vessels. [F-18] RGD-K5 is an investigational agent, which means that it has not yet been approved by the US Food and Drug Administration (FDA).
Unstable atherosclerotic plaque that is prone to rupture is characterized by an increase in the number of macrophages and enhanced angiogenesis. Both neovascular endothelium and macrophages exhibit increased Alpha-v beta3 integrin expression. PET (Positron Emission Tomography) imaging of [F-18] RGD-K5 uptake may identify carotid plaque with increased inflammation and neovascularization and may therefore detect unstable plaque in participants with carotid artery stenosis.
Prior to Dr. Tamarappoo's relocation to Cedars Sinai Medical Center (CSMC), 5 subjects were enrolled at the Cleveland Clinic where PET-CT (Positron Emission Tomography - Computed Tomography) was performed. 6 subjects will be scanned at Cedars using PET-MRI (Positron emission tomography-magnetic resonance imaging). Based on preliminary data with PET-CTA, the investigator strongly believes the study will be able to reproducibly detect significant [F-18] RGD-K5 uptake in plaque from symptomatic patients. Ultimately, demonstrating preferential [F-18] RGD-K5 uptake in symptomatic patients will significantly impact the way in which patients with carotid plaque (at risk for stroke) are treated and it may prevent unnecessary surgical and endovascular procedures in this population
详细描述
The primary objectives of this exploratory study are:
- To assess the uptake of [F-18] RGD-K5 by carotid plaque with PET/MRI imaging in participants prior to carotid endarterectomy and thereby determine if carotid plaque that causes significant stenosis [in participants being considered for carotid endarterectomy (CEA)] is characterized by increased integrin expression and enhanced angiogenesis.
- To collect safety data of [F-18] RGD-K5 in participants with carotid atherosclerosis.
Potential subjects will be identified and approached during an inpatient or outpatient clinical visit by a member of the research team. Potential subjects will be identified by their treating physicians and referred to the researchers. Patients' private and identifiable information will not be shared prior to receiving permission from the patient to do so
Summary of research procedures:
Physical exam and vital Signs:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting
- •a. to the neurologist for evaluation of stroke or TIA (Symptomatic) with: i. Symptomatic patients with plaque ≥70% in at least one carotid artery that would be implicated as the source of embolus responsible for the stroke/TIA. b. or to the vascular surgeon for CEA (Asymptomatic) with: i. asymptomatic patients with a luminal stenosis of ≥70% in at least one carotid artery (stable plaque) referred for CEA ii. age-matched by deciles to symptomatic patients
排除标准
- •stroke due to atrial fibrillation,
- •preexisting carotid stents in the artery of interest,
- •renal dysfunction defined as glomerular filtration rate (GFR) <40ml/min,
- •allergy to gadolinium based contrast agents,
- •Volunteers who have had four or more prior previous gadolinium contrast scans
- •metal implants incompatible with MRI or other condition that prohibits MRI,
- •inability to provide informed consent and
- •age ≤18 years.
研究组 & 干预措施
[F-18] RDG-K5
PET/CT Imaging with administration of [F-18] RGD-K5
干预措施: PET/CT Imaging with [F-18] RGD-K5 (Drug)
结局指标
主要结局
Uptake of [F-18] RGD-K5 by Carotid Plaque With PET/MRI Imaging in the Artery Believed to be the Cause of Transient Ischemic Attack (TIA) or Stroke Symptoms Compared to the Contralateral Carotid Artery Not Implicated in TIA or Stroke
时间窗: within 96 hrs of a stroke or TIA (transient ischemic attack)
To assess the uptake of \[F-18\] RGD-K5 by carotid plaque with PET/MRI imaging in participants prior to carotid enterectomy and thereby determine if carotid plaque that causes TIA or stroke symptoms is characterized by increased integrin expression and enhanced angiogenesis. Each patient serves as their own control. \[F-18\] RGD-K5 (radiotracer) uptake is measured (expressed as target to background ratio) in the carotid artery containing the plaque considered responsible for causing stroke or TIA symptoms (culprit plaque). Plaque maximum standardized uptake value (RT SUVmax) of the radiotracer is compared to tracer maximum standardized uptake value (RT SUVmax) in the contralateral carotid artery which does not contain cluprit plaque.
次要结局
- Number of Participants With Carotid Atherosclerosis(at the time of imaging and immediately following imaging)
研究者
Balaji Tamarappoo
Staff, Cardiac Imaging
Cedars-Sinai Medical Center