NCT05864976招募中不适用
Advancing Neurosurgical Neuronavigation Using Resting State MRI and Machine Learning - a Prospective Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants who are deemed as short-term survivor or a long-term survivor
研究概览
简要总结
This study is investigating the use of a computer algorithm to analyze scans of the brain before surgery to predict how a person's tumor will respond to treatment.
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
- •Must have a radiological diagnosis of a lesion in the brain with characteristics consistent with glioblastoma multiforme.
- •Must be planning to undergo a pre-operative MRI.
- •Must be at least 18 years old.
- •Must be able to understand and willing to sign an IRB approved written informed consent document.
排除标准
- •Contraindication to MRI.
- •Inability to have clinical follow-up (e.g., patient is out of town and will do follow-up elsewhere).
研究组 & 干预措施
Standard of care rsfMRI using the Support Vector Machine algorithm
- Once enrolled, clinical pre-surgical MRI will be done on Siemens 3T Prisma or Skyra scanners using a standard pre-surgical tumor protocol. Resting-state functional MRI (rsfMRI) will be acquired. The Support Vector Machine (SVM) algorithm will be used on this pre-surgical MRI.
- Patients will undergo post-operative MRI at approximately 8-12 weeks following surgical resection to evaluate extent of resection. Patients will then undergo subsequent MRI imaging every 2-3 months as part of routine clinical care to monitor for recurrence. The following MR sequences will be acquired: pre-and post-contrast T1-weighted, T2-weighted FLAIR, diffusion weighted imaging. MRI scans will be reviewed by a board-certified neuroradiologist to determine date of radiographic progression/recurrence. Imaging features at recurrence including location, multifocality, and presence of diffuse or distant recurrence will also be recorded.
干预措施: Support Vector Machine (Device)
结局指标
主要结局
Number of participants who are deemed as short-term survivor or a long-term survivor
时间窗: Through completion of follow-up (estimated to be 2 years)
-Patients will be deemed as a short-term survivor or a long-term survivor and this will be defined as overall survival as less than or greater than 14.5 months, respectively.
次要结局
未报告次要终点
研究者
研究点 (1)
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