Non-Invasive Characterization in Cardiac Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Ratio of 11C-PBR28 in the Myocardium
研究概览
简要总结
In a study of Cardiac sarcoidosis, a serious heart condition, a radiotracer is being used to examine inflammation.
详细描述
Cardiac sarcoidosis is a serious medical condition which affects the heart. The purpose of this study is to characterize the relationship between the FDG PET findings and other markers of inflammation including using a new targeted PET radiotracer, 11C-PBR28, and analysis of blood specimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •18 years of age or older
- •must have undergone a cardiac positron emission tomography (PET) scan using 18F-fluorodeoxyglucose (FDG) for clinical reasons (i.e. referred by your doctor) within the preceding 30 days which showed evidence of active inflammation in your heart.
排除标准
- •If you have two copies of a genetic variation called rs6971 which will prevent this tracer from generating high-quality images you may not participate. If you consent, a blood sample will be drawn to check whether you have this genetic variation.
- •Pregnancy or breastfeeding. If you are female and still experience menstrual periods, you must be willing to use contraception until your participation in the study is complete.
- •Allergy or intolerance to contrast dye containing gadolinium
- •Claustrophobia which would prevent you from completing an approximately one hour MRI scan
- •Inability to lie flat with your arms by your head
- •Abnormal kidney function (estimated GFR(glomerular filtration rate) <60 ml/min/1.73 m2)
- •Implanted pacemaker, defibrillator or other medical devices which are not safe for 3 Tesla MRI
- •Metal in the eyes or shrapnel in the body
- •If you are clinically unstable you may not participate in this study. For example, if you have potentially life threatening abnormal heart rhythms which are not controlled by medication or other treatments, you cannot participate. Also, if you need medications to increase your blood pressure or cardiac function due to weak heart muscle, you cannot participate.
研究组 & 干预措施
11C-PBR PET
Subjects will have a blood sample drawn to evaluate the presence of a specific genetic variation which would prevent the new type of imaging test we are evaluating from working and we will test the inflammatory cells in the blood for the same purpose.
All participants who proceed will have to return on at least one additional day to undergo a positron emission tomography (PET) scan similar to the scan your doctor ordered. we will use 11C-PBR28 as the radiotracer. This study will evaluate whether 11C-PBR28 can show areas of inflammation due to cardiac sarcoidosis. On either the same day or a different day, you will also undergo a cardiac MRI.
干预措施: 11C-PBR PET (Device)
结局指标
主要结局
Ratio of 11C-PBR28 in the Myocardium
时间窗: 1 hour scan
The primary outcome of this study will be the ratio of 11C-PBR28 PET activity in myocardial regions with inflammation indicated by FDG PET and/or edema indicated by increased T2 signal with cardiac MRI compared to the 11C-PBR28 PET activity in myocardial segments which appear normal on FDG PET and cardiac MRI. The primary outcome is thus the intensity of uptake in abnormal regions as a percentage of the intensity of uptake in normal segments.
次要结局
- The Ratio of 11C-PBR28 PET Activity in Cardiac Regions With Fibrosis(1 hour scan)
研究者
Venkatesh L. Murthy, M.D., Ph.D.
Principal Investigator
University of Michigan