PET Imaging of Translocator Protein in Subjects With Traumatic Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Receptor Binding (Vt)
研究概览
简要总结
Background:
- People with traumatic brain injury (TBI) often have inflammation in the brain. A protein called the translocator protein (TSPO) is often present with inflammation. Researchers want to see if a radioactive chemical known as [11C]PBR28 can be used to study TSPO and inflammation in the brain of people with TBI.
Objectives:
- To test whether [11C]PBR28 can be used to study changes in the brain after a traumatic brain injury.
Eligibility:
- Individuals at least 18 years of age who have had TBI and have had a brain scan that shows signs of inflammation.
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- All participants will have two brain scans during an outpatient visit. A magnetic resonance imaging scan will study brain activity. A positron emission tomography (PET) scan will use [11C]PBR28 to look for signs of TSPO and brain inflammation.
- Participants with TBI will have two PET scans within 10 days of the head injury, and a PET scan around 90 days after the injury. They may also have MRI scans under this or another study. Tests of thinking, memory, and concentration will be used to study the effects of the injury and inflammation
详细描述
Objective:
Brain damage following traumatic injury (TBI) results from both direct (e.g., mechanical injury to the brain and vasculature) and indirect mechanisms (e.g., secondary mechanisms such as inflammation). While CT and MRI can help visualize the result of inflammatory processes in the brain for instance, the development of cerebral edema neither method can be used to document active inflammation itself. The translocator protein (TSPO), which is highly expressed in microglia and reactive astrocytes, has been used as a biomarker in positron emission tomography (PET) to identify active inflammatory processes. Recently, our laboratory developed PBR28, a new PET ligand that images TSPO with high levels of specific binding. We have successfully used PBR28 to investigate a number of brain disorders such as epilepsy, multiple sclerosis, and HIV infection with minor cognitive motor disorder, and are detecting neuroinflammation. The current protocol aims to explore whether PBR28 PET imaging can show changes in subjects with TBI who have shown MRI abnormalities in the acute phase and also in those who are in the chronic phase of TBI.
Study population: The following three groups will be studied:
TBI subjects who had brain injury within approximately 3 months and have exhibited MRI abnormalities consistent with TBI and who are enrolled in "Evaluation, Pathogenesis, and Outcome of Subjects with or Suspected Traumatic Brain Injury" (10-N-N122, PI Latour), "Evaluation and Diagnosis of Potential Research Subjects with Traumatic Brain Injury (TBI), (11-N-0084, PI: Lawrence Latour), or other CNRM protocols. N = 20
TBI subjects who had brain injury more than approximately 5 month ago, are enrolled in 11-N-0084, and meet criteria of TBI established by CNRM. N = 20
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Baseline brain PET in acute TBI patient
Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to baseline brain positron emission tomography (PET) scan in Acute (< 5 months post-injury) traumatic brain injury (TBI) patients.
干预措施: [11C]PBR28 and Positron Emission Tomography (PET) (Drug)
Repeat brain PET in acute TBI patient
Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to repeat brain positron emission tomography (PET) scan in Acute (< 5 months post-injury) traumatic brain injury (TBI) patients.
干预措施: [11C]PBR28 and Positron Emission Tomography (PET) (Drug)
Single brain PET in Chronic TBI patient
Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to brain positron emission tomography (PET) scan in Chronic (5 months - 5 years post-injury) traumatic brain injury (TBI) patients.
干预措施: [11C]PBR28 and Positron Emission Tomography (PET) (Drug)
Single brain PET in healthy subjects
Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to brain positron emission tomography (PET) scan in Healthy Subjects.
干预措施: [11C]PBR28 and Positron Emission Tomography (PET) (Drug)
结局指标
主要结局
Receptor Binding (Vt)
时间窗: 120 minutes from the start of the PET scan
To determine total distribution volume of \[C-11\]PBR28 in the whole brain using PET and arterial input function (concentration of radioligand in arterial plasma over time).
Receptor Binding Corrected for Plasma (Vt/fp)
时间窗: 120 minutes from the start of the PET scan
Total distribution volume divided by plasma free fraction (fp) of \[C-11\]PBR28. Measured with PET and arterial input function (concentration of radioligand in arterial plasma over time).
次要结局
未报告次要终点
