Pilot Study for Non-invasive Glioma Characterization Through Molecular Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 2HG Concentration via 3T MRI Scanner
研究概览
简要总结
MRI-based sequences can provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.
详细描述
This is a pilot study aiming at developing and optimizing MRI-based sequences to provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 year old)
- •Subjects with suspected or confirmed gliomas and who will have a medically indicated biopsy or resection of his/her brain lesion.
排除标准
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Patients unable to have MRI done
研究组 & 干预措施
IDH-Mutant Glioma Patients
Patients who have suspected or confirmed gliomas and are scheduled to undergo biopsy or resection of their brain tumors will receive a 3 Tesla (3T) Magnetic Resonance Imaging (MRI) scan of their brain.
干预措施: 3T MRI Scanner (Device)
结局指标
主要结局
2HG Concentration via 3T MRI Scanner
时间窗: Day 1
2HG concentrations as measured via 3T MRI Scanner.
2HG Concentration from tissue samples
时间窗: Day 1
2HG concentrations as measured via patient's surgically excised tissue sample ex vivo by tissue based liquid chromatography-mass spectrometry (LC-MS)
次要结局
未报告次要终点
研究者
Macarena De La Fuente, MD
Assistance Professor
University of Miami