Noninvasive Assessment of Abdominal Aortic Aneurysm (AAA) Wall Structural Integrity and Inflammation as Predictors of Expansion and/or Rupture
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Standard Uptake Value (SUV)
研究概览
简要总结
Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or because they do not have an AAA (control group).
The purpose of this research study is to further study, through FEA, changes that occur in the mechanical properties of the aortic wall. The investigator will compare two radiotracers, 18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging during the PET-CT scan. The investigator will also compare the results describing the mechanical properties of the AAA wall to the degree of inflammation in that wall as determined by PET-CT imaging to define new and better predictors of AAA growth and/or rupture.
详细描述
Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or because they do not have an AAA (control group).
The aorta serves as the main artery to supply blood flow to the body. It is approximately the size of a garden hose. Due to the effects of high blood pressure (hypertension), atherosclerosis (hardening of the arteries), and tobacco use, the aorta may widen and enlarge to form an aneurysm. An abdominal aortic aneurysm (AAA) is a dilation (enlargement) or ballooning out of a section of blood vessel caused by disease or weakness in the wall of the aorta below the level of the kidney arteries. As an AAA dilates and increases in size, rupture of the AAA may occur. AAA rupture carries a significant risk of death.
Currently, aortic size is the primary factor used to assess aortic rupture risk. There are other imaging procedures (imaging modalities) that are being used and developed to assess AAA rupture risk. Finite element analysis (FEA) is a way to study the mechanical properties of the aortic wall, including areas of stress and strength that are used to calculate rupture risk. Positron Emission Tomography (PET) utilizes glucose (a form of sugar) labeled with a radioactivity to look at the metabolic activity and inflammation in the aortic wall.
The purpose of this research study is to further study, through FEA, changes that occur in the mechanical properties of the aortic wall. The investigator will compare two radiotracers, 18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging during the PET-CT scan. The investigator will also compare the results describing the mechanical properties of the AAA wall to the degree of inflammation in that wall as determined by PET-CT imaging to define new and better predictors of AAA growth and/or rupture.
The radioactive tracers that are used in this study are 18F-fludeoxyglucose (FDG) and 11C-PBR28 (PBR) which stands for Peripheral Benzodiazepine Receptor. 11C-PBR28 is considered investigational, which means that it has not been approved by the U.S. Food and Drug Administration. FDG is an approved drug by the FDA, however in this study it is considered investigational.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control Group
Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
干预措施: Assess AAA rupture risk by PET-CTA scans (Drug)
Control Group
Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
干预措施: 18F-fludeoxyglucose (FDG) (Drug)
Control Group
Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
干预措施: 11C-PBR28 (Diagnostic Test)
Small AAA's
Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
干预措施: Assess AAA rupture risk by PET-CTA scans (Drug)
Small AAA's
Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
干预措施: 18F-fludeoxyglucose (FDG) (Drug)
Small AAA's
Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
干预措施: 11C-PBR28 (Diagnostic Test)
Rapidly expanding AAA's
Six subjects (three males and three females) with rapidly expanding AAAs (>0.5cm over 6 months and/or >1.0cm over 12 months).
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
干预措施: Assess AAA rupture risk by PET-CTA scans (Drug)
Rapidly expanding AAA's
Six subjects (three males and three females) with rapidly expanding AAAs (>0.5cm over 6 months and/or >1.0cm over 12 months).
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
干预措施: 18F-fludeoxyglucose (FDG) (Drug)
Rapidly expanding AAA's
Six subjects (three males and three females) with rapidly expanding AAAs (>0.5cm over 6 months and/or >1.0cm over 12 months).
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
干预措施: 11C-PBR28 (Diagnostic Test)
AAA's undergoing treatment
Six subjects (three males, AAA >5.5cm and three females, AAA >5.0cm) with AAAs that are indicated for treatment.
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
干预措施: Assess AAA rupture risk by PET-CTA scans (Drug)
AAA's undergoing treatment
Six subjects (three males, AAA >5.5cm and three females, AAA >5.0cm) with AAAs that are indicated for treatment.
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
干预措施: 18F-fludeoxyglucose (FDG) (Drug)
AAA's undergoing treatment
Six subjects (three males, AAA >5.5cm and three females, AAA >5.0cm) with AAAs that are indicated for treatment.
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
干预措施: 11C-PBR28 (Diagnostic Test)
结局指标
主要结局
Standard Uptake Value (SUV)
时间窗: 1 day
Aortic inflammation as demonstrated by uptake of radiotracer
次要结局
- Qualitative Comparison of SUV and RPI(9-10 months)
- Rupture Potential Index (RPI)(9-10 months)