PET Imaging of Cyclooxygenases in Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]PS13
研究概览
简要总结
Background:
Multiple sclerosis (MS) is an autoimmune disease that has no cure. MRI is the main tool used in the study and treatment of people with MS. Tracers have been developed for cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), key enzymes that involved in neuroinflammation. Researchers want to explore the role inflammation plays in MS and see if COX-1 and COX-2 are measurable in the brains of people with the disease.
Objective:
To see if COX-1 and COX-2 are detectable in the brains of individuals with MS.
Eligibility:
People ages 18 and older with MS who are otherwise healthy.
Design:
Participants will be screened with their medical history and a physical exam. They will have an EKG to check the electrical activity of the heart.
Participants study involvement requires 3 to 5 visits and will last between 2 weeks and 4 months.
Participants will have two positron emission tomography (PET) scans of the brain for each tracer. Scans of the same tracer might occur on the same day or on separate days. A small amount of a radioactive chemical will be injected through an intravenous catheter. A needle will be used to guide a thin plastic tube into an arm vein. The needle will be removed. Only the catheter will be left in the vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. They will wear a plastic mask molded to fit the head. The scan will last about 90 minutes for each tracer. Participants will receive the medication ketoprofen or celecoxib orally about 2 hours before the second scan.
Participants will have blood tests.
Participants must avoid certain medications a month prior to the PET scans.
详细描述
Study Description: This study will examine whether cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2) are elevated in the brain of individuals with Multiple Sclerosis (MS)
Objectives: To determine whether COX-1 and COX-2 are detectable in the brains of individuals with MS.
Endpoints:
Primary endpoint: Calculation of COX-1 and COX-2 densities from [11C]PS13 and [11C]MC1 PET scans, respectively, using baseline scans and scans after blockade with ketoprofen and celecoxib, respectively.
Secondary endpoint: 1) Comparison of [11C]PS13 and [11C]MC1 specific uptake in different types of MS lesions (active, chronic active, inactive) and in normal white matter. 2) Comparison of [11C]PS13 and [11C]MC1 specific uptake in the brain lesions of the same subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
Participants with multiple sclerosis
Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline [11C]PS13 scan followed by a second [11C]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline [11C]MC1 scan followed by a second scan with [11C]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of [11C]PS13 or [11C]MC1 during each scan.
干预措施: 11C-MC1 (Drug)
Participants with multiple sclerosis
Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline [11C]PS13 scan followed by a second [11C]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline [11C]MC1 scan followed by a second scan with [11C]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of [11C]PS13 or [11C]MC1 during each scan.
干预措施: 11C-PS13 (Drug)
Participants with multiple sclerosis
Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline [11C]PS13 scan followed by a second [11C]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline [11C]MC1 scan followed by a second scan with [11C]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of [11C]PS13 or [11C]MC1 during each scan.
干预措施: Ketoprofen (Drug)
Participants with multiple sclerosis
Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline [11C]PS13 scan followed by a second [11C]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline [11C]MC1 scan followed by a second scan with [11C]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of [11C]PS13 or [11C]MC1 during each scan.
干预措施: Celecoxib (Drug)
结局指标
主要结局
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]PS13
时间窗: 60-90 minutes after the start of PET scan
Standard uptake value (SUV) was measured by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of \[11C\]PS13. The SUVR was calculated by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the caudate from 60-90 minutes after the start of the PET scan.
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]MC1
时间窗: 60-90 minutes after the start of PET scan
Standard uptake value (SUV) was measured by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of \[11C\]MC1. The SUVR was calculated by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the cerebellum from 60-90 minutes after the start of the PET scan.
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]PS13 After Blockade With Ketoprofen
时间窗: 60-90 minutes after the start of PET scan
Calculation of standard uptake value (SUV) by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of \[11C\]PS13 after blockade with ketoprofen. Calculation of SUVR by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the caudate from 60-90 minutes after the start of the PET scan.
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]MC1 After Blockade With Celecoxib
时间窗: 60-90 minutes after the start of PET scan
Calculation of standard uptake value (SUV) by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of \[11C\]MC1 after blockade with celecoxib. Calculation of SUVR by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the cerebellum from 60-90 minutes after the start of the PET scan.
次要结局
- Standard Uptake Value Ratio (SUVR) of Chronic Active Lesions With Injection of [11C]MC1(60-90 minutes after the start of PET scan)
- Standard Uptake Value Ratio (SUVR) of Chronic Active Lesions With Injection of [11C]PS13(60-90 minutes after the start of PET scan)