Membrane Potential Mapping with18F-TPP
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Tracers volume of distribution (VT)
研究概览
简要总结
In this study, investigators propose to use PET imaging to study the pharmacokinetics of 18F-TPP and develop methods for imaging membrane potential (ΔΨT) in humans.
详细描述
The aims of this study are:
- Assessment of the pharmacokinetics of primed constant infusion of 18F-TPP in humans.
- Assessment of normal variation of membrane potential (ΔΨT) and extracellular space (ECS) in a cohort of "normal" subjects.
- Assessment of the pharmacokinetics of bolus injection of 18F-TPP in humans. Studies will be performed on a PET/CT scanner. A separate MRI will be collected.
Each scan may or may not have arterial blood sampling for measurement of the time course of radioactivity in the whole-blood, plasma and radiometabolite analysis on selected plasma samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give voluntary written informed consent
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •In good general health as evidenced by medical history, physical examination, ECG, serum/urine biochemistry and hematology tests.
- •If female of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study.
排除标准
- •Know structural heart disease (e.g. myocardial infarction)
- •Abnormal and clinically significant ECG (as determined by the Investigator or his/her designee) at screening.
- •Laboratory tests with clinically significant abnormalities at screening
- •Pregnancy or Lactation
- •MRI incompatible implants (i.e., such as pacemaker, artificial joints, non-removable body piercings) and other contraindications for MRI, such as claustrophobia, having implanted or embedded metal objects/fragments or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist).
- •Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits followed by the Yale University PET Center.
- •Subject who has current, past, or anticipated exposure to radiation in the workplace within one year of the proposed research scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
- •Has any condition that, in the opinion of the investigator, would prevent compliance with the study protocol.
- •Arterial Line Exclusion: Blood donation within eight weeks of the start of the study.
- •Arterial Line Exclusion: History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
- •Arterial Line Exclusion: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) greater than 5msec above the upper limit of normal.
- •Arterial Line Exclusion: Unable to safely discontinue or hold aspirin and other NSAID use
研究组 & 干预措施
18F-TPP
PET imaging to study the pharmacokinetics of 18F-TPP and develop methods for imaging membrane potential (ΔΨT) in humans. Each scan may or may not have arterial blood sampling for measurement of the time course of radioactivity in the whole-blood, plasma and radiometabolite analysis on selected plasma samples.
干预措施: 18F-TPP (Drug)
结局指标
主要结局
Tracers volume of distribution (VT)
时间窗: Visit 2 (up to 90 days post screening visit 1)
Maps of the 18F-TPP tracer volume of distribution (VT) and ΔΨT based on quantitative analysis of PET imaging.
次要结局
未报告次要终点
研究者
Georges El Fakhri
Professor of Radiology and Biomedical Imaging, Therapeutic Radiology and of Biomedical Informatics
Yale University