NCT05369689尚未招募不适用
Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics
Zhuang Hongqing1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This study aims to assess multimodal Radiomics-based prediction model for prognostic prediction in spinal tumors.
详细描述
Sensitivity for prediction recurrence and survival of currently available prognostic scores is limited. This study proposes to establish a multimodal radiomics model for identifying tumor recurrence and prognostic prediction of spinal tumors. The study will investigate the relationship between the radiomics and the tumor microenvironment. The study includes the construction of multimodal radiomics-based prediction model and the validation of the prediction model.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of spinal tumors for which SBRT is appropriate Karnofsky Performance Status >60 Life expectancy of at least 3 months No contraindication to undergoing MR imaging Age >18 Complete the CT MRI or PET-CT examination before and after treatment Accept stereotactic radiosurgery
排除标准
- •Subjects unable to undergo MRI (includes non-MRI compatible material or devices and severe claustrophobia) Subjects with prior procedural intervention to the involved vertebral body that would result in artifact (kyphoplasty, screw and/or rod placement); minimally invasive surgery without instrumentation of the involved vertebral body and instrumentation immediately above or below the index lesion is allowed.
- •Subjects with spinal cord compression; minimally invasive "separation" surgery to first resect the epidural component is allowed Pregnant or breast-feeding women Allergy to standard IV contrast agents used in MRI
结局指标
主要结局
PFS
时间窗: 1 years
progression-free survival
次要结局
- ORR(3 months)
- Recurrence free survival (RFS)(1 year)
- Overall survival (OS)(1 years)
- DCR(3 months)
研究者
Zhuang Hongqing
Associate department chairman of radiotherapy
Peking University Third Hospital
研究点 (1)
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