Targeted Molecular Probe for Abdominal Aortic Aneurysm Imaging and Therapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- First in-person CCR2 molecular imaging using 64Cu-DOTA-ECL1i PET/CT in AAA patient
研究概览
简要总结
The purpose of this research study is to look at whether an investigational imaging agent, 64Cu-DOTA-ECL1i, used during Positron Emission Tomography (PET)/ Computed Tomography (CT) scanning, can help to identify conditions that place patients at an increased risk for AAA rupture. The study is also looking more closely at cellular, molecular and inflammatory properties of the aortic wall. Having the ability to identify markers that predict AAA progression/expansion and risk for rupture could allow the physician to manage patients in a more individualized, personal way.
详细描述
Abdominal aortic aneurysm (AAA) is a life-threatening degenerative vascular disease characterized by transmural aortic macrophage infiltration, elastin degradation, and reduction of smooth muscle cell content. AAAs occurs later in life and are especially prevalent in men over the age of 65. Patients typically remain asymptomatic until rupture, which is associated with high mortality. Currently, surgical repair is the only approach for AAA treatment, and there is no pharmacological intervention. Clinically, ultrasound and computed tomography measurement of aneurysm diameter represents the mainstay of management and the principal determinant of timing for elective surgical repair. However, this anatomy-based approach fails to provide useful information about the cellular and molecular processes associated with aneurysm expansion and rupture. Therefore, developing translatable molecular biomarkers, specifically expressed by aneurysms, is necessary to determine associated status and progression, capture the risk of rupture, and deliver personalized treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with aortoiliac occlusive disease causing lifestyle limiting claudication, rest pain, and/or tissue loss that requires aortofemoral bypass
排除标准
- •Patients with aortoiliac occlusive disease, we will apply the same exclusion criteria as AAA patients.
- •Abdominal Aortic Aneurysm (AAA) Patients, (Aim 2B, n=5)
- •Inclusion Criteria:
- •We will recruit asymptomatic patients with known AAAs by ultrasound, Doppler, and CT (men ≥ 5.5 cm, women ≥ 5.0cm);
- •Both men and women, between the ages of 45 -75;
- •With or without active tobacco use;
- •Exclusion Criteria:
- •Inability to receive and sign informed consent;
- •Has a history of hypersensitivity to contrast agent, Iopamidol (Isovue)
- •Patients with Stage ≥ 4 chronic renal failure (calculated by modification of diet in renal disease eGFR equation [to minimize confounding imaging variables]);
- •Inability to tolerate 60 minutes in a supine position with arms down at sides, as necessary for PET/CT;
- •Severe claustrophobia;
- •Positive pregnancy test or lactating;
- •Has a history of hypersensitivity to 64Cu-DOTA-ECL1i or any of its excipients;
- •Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data such as: Symptomatic/recently treated coronary disease, cancer requiring oncologic management, or autoimmune/inflammatory diseases (e.g., rheumatoid arthritis or multiple sclerosis) that are known to have increased associated expression of CCR2.
结局指标
主要结局
First in-person CCR2 molecular imaging using 64Cu-DOTA-ECL1i PET/CT in AAA patient
时间窗: 1-2 weeks
Determine the background retention of 64Cu-DOTA-ECL1i in the abdominal aorta of patients with non-aneurysmal, atherosclerotic occlusive disease.
Perform 64Cu-DOTA-ECL1i PET/CT in AAA patients and correlate imaging readouts with tissue inflammatory biomarkers in patients undergoing open repair
时间窗: 1-2 weeks prior to surgery
Patients undergoing open AAA repair will be scheduled for PET/CT imaging at 1-2 weeks prior to surgery. This will be first-in-patient molecular imaging using CCR2 targeted 64Cu-DOTA-ECL1i in AAA patients undergoing open repair. The surgically removed aneurysmal tissue will be collected and processed for a complete characterization.
次要结局
未报告次要终点