跳至主要内容
临床试验/NCT03072979
NCT03072979Unknown不适用

Reduction in Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年1月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
18
试验地点
1
主要终点
Reduction in vasculature

研究概览

简要总结

Pre-clinical evidence suggests that radiotherapy reduces tumour-associated vasculature. The investigators will conduct a single-arm prospective study to quantify the reduction in tumour vasculature post-radiotherapy

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥21 years of age
  • Proven metastatic disease, excluding haematological and germ cell neoplasms
  • Life expectancy >3 months, Eastern Cooperative Oncology group (ECOG) 0-2

排除标准

  • The patient must not have an allergy to gadolinium contrast that will limit the ability to image the tumour by MRI safely even with the use of premedication
  • eGFR < 30 mL/min or if patient is suffering from acute renal insufficiency
  • Prior radiotherapy to the specified region
  • Recent surgery to affected spinal levels, or patients requiring immediate surgical intervention
  • Spinal instability score (SINS) >12
  • Symptomatic cord compression (Bilksy grade 2 or 3), or worsening neurological deficits
  • Body weight of more than 120kg
  • Pregnancy

结局指标

主要结局

Reduction in vasculature

时间窗: 3 month

Reduction in vasculature measured by changes on Dynamic Contrast enhanced MRI

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Radiation Oncology

Dr Balamurugan Vellayappan

National University Hospital, Singapore

研究点 (1)

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