Phase 1 Study Evaluating the Safety of [11C]MeDAS Myelin-Targeting PET Agent in Humans
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Radiation dosimetry
研究概览
简要总结
This study evaluates the safety of [11C]MeDAS, a PET radiotracer.
详细描述
Myelin PET imaging provides a new type of information regarding the integrity of the central nervous system based on molecular imaging of myelin. Preclinical studies have shown [11C] MeDAS uptake in the brain and spinal cord to be an indicator of the microstructural integrity of the tissue.
[11C]MeDAS PET (Positron Emission Tomography) scans will be performed on healthy subjects at 2 timepoints to assess for safety of the radiotracer and to assess its performance in humans. Following measurement of [11C]MeDAS pharmacokinetics and biodistribution, an optimal protocol for dosing and imaging will be established.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject reports no known physical diseases of the central nervous system including no history of mental health disorders.
- •Capable of giving informed consent
- •Efforts will be made to include approximately equal numbers of women and men. Efforts will be made to include individuals of diverse ethnicities, as reflected in the local clinic population.
排除标准
- •Age <18 or >65
- •History of malignant hypertension or hypertensive crisis
- •Known infectious disease requiring treatment during the course of the study
- •Subject reported history of substance abuse
- •inability to undergo an MRI or PET scan
研究组 & 干预措施
Single Arm: Healthy subjects
The PET radiotracer Myeliviz ([11C]MeDAS) will be administered to healthy subjects twice and PET scans will be obtained each time. This will allow assessment of the PET image quality, PET scan reproducibility and radiotracer distribution.
干预措施: [11C]MeDAS (Drug)
结局指标
主要结局
Radiation dosimetry
时间窗: Less than or equal to 2 hours
Whole body radiotracer uptake, as measured using PET scan image data. Radiotracer uptake will be measured in absolute counts and using distribution volume ratios.
Pharmacokinetic analysis based on PET scan data
时间窗: Less than or equal to 2 hours
Determination of time-dependent radiotracer distribution using PET scan image data, with time measurement in minutes, PET data measured in absolute counts, and position in the body determined by organ segmentation.
Biodistribution analysis
时间窗: Less than or equal to 2 hours
Organ-specific radiotracer uptake, as measured using PET scan image data. Radiotracer uptake will be measured in absolute counts and using distribution volume ratios.
Metabolism analysis
时间窗: Less than or equal to 2 hours
Analysis of in vivo radiotracer metabolism using liquid chromatography, with quantification of relative peak areas under the curve.
Analysis of time-dependent radiotracer distribution based on arterial blood sampling
时间窗: Less than or equal to 2 hours
Determination of time-dependent radiotracer distribution as assessed by arterial blood sampling, using scintillation counting for determination of radiotracer activity. Time is measured in minutes and radiotracer quantity is assayed by scintillation counting with units in absolute counts.
次要结局
- Spinal cord imaging characterization(Less than or equal to 2 hours)
- Brain imaging characterization(Less than or equal to 2 hours)
研究者
Robert Fox
Vice Chair, Research
The Cleveland Clinic