Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Mayo Clinic
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Pathological state of the tissue
研究概览
简要总结
This study explores whether DESI-MS can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery.
详细描述
PRIMARY OBJECTIVES:
I. To explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to:
Ia. Identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; Ib. Identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and therefore differentiate between IDH-mutant and wild-type gliomas.
OUTLINE: This is an observational study.
Patients undergo tissue sample collection and DESI-MS during standard of care surgery and have their medical records reviewed on study. Patients also undergo MRI per standard of care on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male and female patients age 18 and older
- •Patients or their legally authorized representative (LAR) able to provide written consent
- •Schedule to undergo tumor resection
排除标准
- •Pregnant women
结局指标
主要结局
Pathological state of the tissue
时间窗: Up to 5 years
Will use desorption electrospray ionization mass spectrometry (DESI-MS) to identify cancerous versus noncancerous tissue monitoring depletion of N-acetyl aspartate (NAA) and aberrations of the phospholipid signature (components of the cell membrane) of neurological tissue.
Percentage of tumor infiltration
时间窗: Up to 5 years
Will estimate the percentage of tumor infiltration in tissue biopsies by monitoring depletion of NAA and aberrations of the phospholipid signature of neurological tissue.
Presence of IDH mutations
时间窗: Up to 5 years
Will use DESI-MS to identify the presence of isocitrate dehydrogenase (IDH) mutations by monitoring the 2-hydroxyglutarate (2HG) and therefore differentiate between IDH-mutant and wild-type gliomas.
次要结局
未报告次要终点