Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Development of 13C ratio maps in the brain of healthy participants
研究概览
简要总结
Investigators propose to develop hyperpolarized [13C]-labeled pyruvate as potential imaging probes to assess two essential in vivo processes in cerebral metabolism: oxidative metabolism and synthesis of a neurotransmitter in this observational study.
详细描述
Investigators will perform a pilot study to test the translational feasibility by evaluating sensitivity and repeatability of hyperpolarized [1-13C]pyruvate and [2-13C]pyruvate in healthy human subjects (n =10 each). Each subject will be imaged twice using the same hyperpolarized substrate with an interval (<45min) between the injections to evaluate repeatability. Finally, eight subjects will be imaged with both hyperpolarized [1-13C]pyruvate and [2-13C]pyruvate for comparison.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 through 60 years of age.
- •Healthy, with no neurological abnormalities.
- •Ability to understand and the willingness to sign a written informed consent.
- •All races and ethnicities will be included; subjects must be able to read and speak the English language.
排除标准
- •Metallic foreign bodies on the scalp or cranium which may interfere with MRI acquisitions
- •Major debilitating neurological disease including, but not limited to, stroke, CVA, dementia and tumor that would limit compliance with study requirements
- •Under influence of illicit drugs which are known to alter brain physiology/metabolism including, but not limited to cocaine, lysergic acid diethylamide (LSD), and marijuana at the time of MRI/MRSI scanning.
- •Under influence of antiepileptic drugs at the time of MRI/MRSI scanning.
- •Any contraindication per MRI Screening Form including
- •Implants contraindicated at 3T, pacemakers
- •Implantable Cardioverter Defibrillator (ICD)
- •Claustrophobia
- •Medically unstable including
- •Heart failure
- •Severe left ventricular outflow tract (LVOT) obstruction
- •Unstable angina
- •Pregnancy
- •Lactating
研究组 & 干预措施
Hyperpolarized [13C]pyruvate
Hyperpolarized stable isotope injection ([13C]pyruvate) during magnetic resonance spectroscopic imaging
结局指标
主要结局
Development of 13C ratio maps in the brain of healthy participants
时间窗: Measurements made during study scan
Product ratios (Bicarbonate/Lactate, Glutamate/Lactate) will be acquired from the hyperpolarized 13C imaging
次要结局
未报告次要终点
研究者
Jae Mo Park
Principal Investigator
University of Texas Southwestern Medical Center