Exploratory Study of Entire-body PET Scans for Multiple Sclerosis
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Entire-body PET imaging of demyelination of peripheral and central nervous system
研究概览
简要总结
To evaluate whether an entire-body positron emission tomography (PET) scanner can be exploited to improve evaluation, monitoring and measurement of both peripheral and central demyelination in multiple sclerosis (MS) patients.
详细描述
To collect exploratory data using the most recent PET-CT scanners with their increased detection sensitivity and spatial resolution for the evaluation of F18-florbetapir radiopharmaceutical uptake in the nervous system of the entire body with special attention to correlation of radiotracer activity levels in the myelinated, demyelinated, or remyelinated white matter of multiple sclerosis (MS) patients compared to normal healthy subjects. The pilot study will be conducted on 20 participants as a clinical research trial of PET amyloid and myelin imaging with the primary objective of identifying possible differences in F18-florbetapir radiotracer activity for MS patients compared to normal healthy subjects, and the secondary objective of monitoring psychological health of those participants who elect to be informed of imaging results and who complete a panel of psychometric scales before and after imaging results disclosure.
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
盲法说明
Participants will be de-identified; results will be anonymized.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Multiple sclerosis (MS) patients diagnosed by a credentialed neurologist experienced with care of multiple sclerosis patients.
- •Normal healthy subjects.
- •Willing and able to lie motionless on the PET-CT scanner bed for at least 10 minutes and up to 20 minutes for the duration of the PET-CT medical imaging scan.
排除标准
- •Any additional complicating medical illness other than MS including any other neuropsychiatric illness unrelated to MS diagnosed prior to the onset of initial symptoms of MS.
- •Pregnancy or breast feeding.
- •Diabetes or other metabolic-endocrine disorders.
- •Any known concomitant acute infection.
- •History of metastatic or locally invasive cancer.
- •Recent surgery, chemotherapy or radiation therapy.
研究组 & 干预措施
Siemens Biograph Vision PET-CT scans
Parallel study arms defined by PET-CT scanners by different manufacturer and model
干预措施: Entire-body PET-CT scans (Diagnostic Test)
Siemens Biograph Vision PET-CT scans
Parallel study arms defined by PET-CT scanners by different manufacturer and model
干预措施: Amyvid radiopharmaceutical (Drug)
United Imaging uEXPLORER PET-CT scans
Parallel study arms defined by PET-CT scanners by different manufacturer and model
干预措施: Entire-body PET-CT scans (Diagnostic Test)
United Imaging uEXPLORER PET-CT scans
Parallel study arms defined by PET-CT scanners by different manufacturer and model
干预措施: Amyvid radiopharmaceutical (Drug)
结局指标
主要结局
Entire-body PET imaging of demyelination of peripheral and central nervous system
时间窗: During 1 day single PET-CT scan
Exploratory analysis of relative regional increases and/or decreases of Amyvid activity
Psychometric questionnaire for monitoring psychological health
时间窗: Up to 90 days
Assessments of participants
次要结局
未报告次要终点