Evaluation of a Novel PET Radioligand to Image Cyclooxygenase-1 (COX-1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- PET tracer update
研究概览
简要总结
Background:
A radioligand is a radioactive substance that is used to diagnose diseases. A new ligand is called [11C]PS13. This has a small amount of radioactivity that can be detected by a positron emission tomography (PET) scan. If this ligand works well in this study, researchers may be able to use it to better understand and diagnose brain disorders.
Objectives:
To evaluate if [11C]PS13 can measure its receptor, which is involved in inflammation. To see if researchers get the same results when scanning a person twice.
Eligibility:
Healthy people ages 18 and older who are in Protocol 01-M-0254.
Design:
This study requires three visits of 2-5 hours each.
Participants will have 2 PET scans with [11C]PS13.
A needle will guide a small plastic tube (catheter) into an arm vein. The needle will be removed, leaving only the catheter in the vein. The ligand will be injected through the catheter.
The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner.
Participants will wear a molded a plastic mask that fits the head.
Another catheter will be put into an artery at the wrist or elbow area.
Vital signs will be monitored during the PET scan. Participants will have a test during the PET scan to monitor heart function.
Participants will have blood and urine tests.
Participants will have 1 magnetic resonance imaging (MRI) scan. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder.
详细描述
Objective
The cyclooxygenase (COX) system is implicated in the pathophysiology of brain diseases, including Alzheimer s disease and depression, and is a potential biomarker for neuroinflammation. COX is the rate-limiting enzyme in the synthesis of prostaglandins from arachidonic acid and exists as two primary isoforms COX-1 and COX-2. Our laboratory recently developed [(11)C]PS13, a novel PET ligand to selectively image COX-1, and initial PET scans in monkey demonstrated that [11C]PS13 is a promising ligand.
This study has two primary objectives. First, we will determine whether the uptake of [(11)C]PS13 in brain and periphery reflects the distribution of COX-1, as demonstrated by blocking with a COX-1 preferential drug (aspirin or ketoprofen) and/or no effect with a COX-2 selective drug (celecoxib). Second, we will measure the test/retest reproducibility of brain uptake quantified by compartmental modeling and using arterial and/or venous blood samples.
Study Population
Healthy adult volunteers (aged 18 years or older) will have either whole body imaging (n = 41) or brain imaging (n = 20).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years（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
controls
healthy subjects
干预措施: [11C]PS13 (Drug)
结局指标
主要结局
PET tracer update
时间窗: during PET scan
For whole body imaging, organ uptake will be quantified as a Standardized Uptake Value (SUV), which normalizes for injected activity and body weight. Blockade by aspirin, ketoprofen, and celecoxib will be expressed as a percentage of the baseline scan in each subject and plotted relative to the plasma concentration of the drug at time of the PET scan. For dedicated brain imaging, uptake will be quantified as distribution volume (VT) calculated with compartmental modeling and serial concentrations of parent radioligand in arterial and/or venous plasma.
次要结局
未报告次要终点