Prospective Observational Study of Imaging-based Prediction for Genomic Mutations and Prognosis in Glioma
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
This study aims to evaluate whether MRI can be used to predict genomics and prognosis in glioma. Given the profound prognostic significance of genetic mutations seen in glioma, there have been increasing attempts to correlate imaging characteristics with genetic, mutational and expression patterns. To be able to predict genomics and prognosis based on imaging alone will prove useful in patients with involvement of glioma in delicate areas of the brain and better reflect tumor and molecular heterogeneity.
详细描述
Previous studies have proposed certain imaging characteristics correlating with genetic, molecular and expression patterns. Advanced imaging provides additional clues but no studies have examined its added value particularly in a prospective setting. The investigator's aim to evaluate preoperative MRI for patients suspected of glioma to predict IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status using imaging characteristics such as margin, patterns of contrast enhancement and edema as well as diffusion and perfusion characteristics. This will be confirmed pathologically and further correlated with patients' long term outcome.
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
- •Patients suspected of glioma undergoing MRI examination prior to surgery
- •MRI including advanced imaging such as cerebral blood volume, apparent diffusion coefficient and amide proton transfer imaging
- •Signed informed consent
排除标准
- •Pathologic confirmation as tumors other than glioma
- •Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
- •Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
结局指标
主要结局
Time to progression
时间窗: Through study completion, an average of 2 years
The response was determined by a modification of the response assessment in neuro-oncology (RANO) criteria that combined the image assessment, neurologic evaluation and assessment of steroid use.
次要结局
- Genomics including IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status(2 months)
- Progression free survival(Through study completion, an average of 3 years)
研究者
Ho Sung Kim
Professor
Asan Medical Center