NCT01031199已完成1 期
Open-label, Non-randomized, Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 140 MBq (ca. 5 mSv) ZK 6032924 (BAY85-8101) for Its Diagnostic Potential in Either Drug-naïve or Specifically (IFN-beta) Pretreated Patients With Multiple Sclerosis (MS) With Acute Relapse or Patients With Clinically Isolated Syndrome (CIS), Compared to Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 16
- 主要终点
- Standard quantification variables derived from 3D PET imaging and brain modeling.
研究概览
简要总结
PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers for brain imaging:
- •males or females, age 20 - 55 years
- •assessment of the brain MRI as "normal (age-appropriate)"
- •absence of any sign of CNS disease, no co-medi cation Patients for brain imaging
- •males or females, age 20 - 55 years
- •patients with previously diagnosed MS, presenting with acute relapse, without any current immunomodulating therapy for MS ("drug-naïve"), or patients presenting with first clinical episode suggestive of demyelinating disease (Clinically Isolated Syndrome, CIS)
- •patients with previously diagnosed MS, presenting with acute relapse, receiving currently immunomodulatory therapy exclusively with interferon β
- •MRI: >/= 2 T2 lesions and >/= 1 Gadolinium- (Gd-) enhancing lesion
排除标准
- •Exclusion criteria for all healthy volunteers and patients:
- •Pregnancy or lactation
- •Any disease, condition, or concomitant medications that significantly compromises the function of the body systems and could result in excessive accumulation, impaired metabolism, altered excretion of the radiotracer, or might interfere with the conduct of the study or interpretation of the results
- •other forms of diseases with neuroinflammatory components
研究组 & 干预措施
Arm 1
Experimental
干预措施: F-18 FEDAA1106 (BAY85-8101) (Drug)
Arm 2
Experimental
干预措施: F-18 FEDAA1106 (BAY85-8101) (Drug)
结局指标
主要结局
Standard quantification variables derived from 3D PET imaging and brain modeling.
时间窗: Day of study tracer administration
Visual analysis/description of the uptake and description of brain PET scans.
时间窗: Day of study tracer administration
次要结局
- Standard Safety Parameter: Adverse Event Collection(maximum time from Screening to Follow-up are 37days)
- Standard Safety Parameter: Electrocardiogram(maximum time from Screening to Follow-up are 37days)
- Standard Safety Parameter: Safety laboratory(maximum time from Screening to Follow-up are 37days)
- Standard Safety Parameter: Vital signs(maximum time from Screening to Follow-up are 37days)
研究者
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