Utility of Hyperpolarized 13C-Pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis of Early Cerebral Metabolic Crisis After Traumatic Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Measures of conversion of pyruvate to lactate (apparent conversion rate constant kPL, lactate-to-pyruvate ratio) and pyruvate to bicarbonate (apparent conversion rate constant kPB, bicarbonate-to-pyruvate ratio)
研究概览
简要总结
The purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic MRI to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (TBI). This study will also compare HP pyruvate MRI-derived metrics in TBI patients with healthy subjects as well as Subarachnoid hemorrhage (SAH) patients to better understand if metabolic Magnetic resonance imaging scan (MRI) can improve our ability to diagnose a TBI.
The FDA is allowing the use of hyperpolarized [1-13C] pyruvate (HP 13C-pyruvate) in this study.
Up to 15 patients (5 with TBI, 5 with SAH, and 5 healthy volunteers) may take part in this study at the University of Maryland, Baltimore (UMB).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of acute head injury with or suspected non-penetrating acute TBI
- •Suitable to undergo contrast-enhanced MRI
- •Negative serum pregnancy test
排除标准
- •Inability to undergo MRI scan
- •Inability to receive IV MRI contrast agents secondary to severe reaction or renal insufficiency
- •Positive pregnancy test
研究组 & 干预措施
Metabolic MRI in traumatic brain injury patients
Perform metabolic magnetic resonance imaging on patients who have traumatic brain injury to understand early brain metabolism changes in this population
干预措施: Hyperpolarized 13C-Pyruvate (Drug)
Metabolic MRI in subarachnoid hemorrhage patients
Perform metabolic magnetic resonance imaging on patients who have subarachnoid hemorrhage to understand early brain metabolism changes in this population
干预措施: Hyperpolarized 13C-Pyruvate (Drug)
Metabolic MRI in healthy volunteers
Perform metabolic magnetic resonance imaging on healthy volunteers to understand early brain metabolism changes in this population
干预措施: Hyperpolarized 13C-Pyruvate (Drug)
结局指标
主要结局
Measures of conversion of pyruvate to lactate (apparent conversion rate constant kPL, lactate-to-pyruvate ratio) and pyruvate to bicarbonate (apparent conversion rate constant kPB, bicarbonate-to-pyruvate ratio)
时间窗: within two years post enrollment
To assess the differences between the three patient groups
次要结局
- Correlation of the conversion of pyruvate to lactate and pyruvate to bicarbonate measures with results from clinical and neuropsychological evaluation.(within two years post enrollment)
研究者
Jiachen Zhuo
Professor
University of Maryland, Baltimore