跳至主要内容
临床试验/NCT01499823
NCT01499823Unknown不适用

Permeability Map As an Imaging Biomarker to Distinguish Progression From Pseudoprogression in High-Grade Glioma

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
74
试验地点
1
主要终点
Permeability Map to Distinguish Progression From Pseudoprogression in High-grade glioma

研究概览

简要总结

The aim of the present study is to assess whether a new method of quantifying therapy-associated hemodynamic alterations based on DCE MR imaging may help to distinguish pseudoprogression from true progression in patients with high grade glioma, who received CCRT.

详细描述

Combination temozolomide and radiation significantly prolongs survival compared with radiation alone and has become standard treatment for glioblastoma multiforme (GBM). Response assessment in GBM is difficult as a result of the frequent occurrence of early imaging changes indistinguishable from tumor progression, termed pseudoprogression. The majority of patients remain clinically stable. It is often unclear whether current therapy should be maintained or second-line therapy initiated. The incidence of pseudoprogression after concurrent chemoradiation is15%to 30%. A potential mechanism of pseudoprogression is that radiation-induced vascular changes may lead to focal transient increase in gadolinium enhancement. Dynamic contrast-enhanced (DCE) MR imaging provides a noninvasive means for quantifying tumor vascular properties.

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

入选标准

  • Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.

排除标准

  • Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients do not show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.

结局指标

主要结局

Permeability Map to Distinguish Progression From Pseudoprogression in High-grade glioma

时间窗: 2year

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

Seung Hong Choi

Seoul National University Hospital

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验