Correlation of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging and Tumor Histopathology in Patients With Infiltrating Gliomas
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Accuracy of metabolic MRI to diagnose Glioma
研究概览
简要总结
The purpose of this study is to examine the safety and feasibility of performing hyperpolarized metabolic MRI in the diagnosis of brain tumor. This study will also assess the accuracy of hyperpolarized metabolic MRI to diagnose intermediate to patients with infiltrating gliomas and examine the added utility of metabolic MRI over standard MRI imaging
The FDA is allowing the use of hyperpolarized [1-13C] pyruvate (HP 13C-pyruvate) in this study.
Up to 5 patients 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
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients with a new brain lesion interpreted as suspected infiltrating gliomas including but not limited to (diffuse astrocytoma WHO grade 2; oligodendroglioma WHO grade 2 and 3; anaplastic astrocytoma WHO grade 3; astrocytoma WHO grade 4), OR, patients with prior history of infiltrating glioma scheduled for surgery for tumor biopsy or resection.
- •Ages 18-80, including male and female
- •Suitable to undergo contrast-enhanced MRI
- •Negative serum pregnancy test
排除标准
- •Inability to undergo MRI scan
- •Inability to receive IV contrast secondary to severe reaction or renal insufficiency.
研究组 & 干预措施
metabolic MRI
Single-arm study in patients who have Glioma Perform metabolic magnetic resonance imaging on patient have a Glioma cancer to understand if metabolic MRI can be safely performed on this population
干预措施: Hyperpolarized 13C-Pyruvate (Drug)
结局指标
主要结局
Accuracy of metabolic MRI to diagnose Glioma
时间窗: Within three years post treatment
To study the accuracy of hyperpolarized metabolic MRI to diagnose Glioma Cancer. We will compare the prediction of cancer from the MRI scan compared to actual diagnosis of cancer by any subsequent workup or procedure the participant undergoes. Prediction of cancer from MRI scan will be performed by assigning a standardized score . Actual diagnosis of cancer will be based on tissue pathology.
次要结局
- Utility of metabolic MRI over standard MRI imaging in the diagnosis of Glioma cancer(Within three years post treatment)
研究者
Dirk Mayer
Professor
University of Maryland, Baltimore