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临床试验/NCT02212964
NCT02212964已完成不适用

Differentiation of Pseudoprogression and True Progression Through High Field Susceptibility Weighted Imaging and R2*

Centre for Functional and Metabolic Mapping1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
Disease Progression

研究概览

简要总结

Using a multi-echo gradient echo sequence to calculate R2* and quantitative susceptibility maps and well as susceptibility-weighted imaging post processing the investigators hypothesize that the investigators would be able to distinguish between pseudoprogression and true progression with the use of an easily implementable sequence on clinical MRI scanners.

详细描述

Post-treatment radiographic imaging change (PTRIC) is seen in approximately 50% of patients who are treated for brain neoplasms using chemotherapy and radiotherapy. PTRIC can be attributed to true disease progression or a form of benign radiographic enhancement, known in literature as pseudoprogression. Of these patients, 50% of them have benign radiographic enhancement that is usually spontaneously resolved and required no intervention. The other 50% require immediate medical intervention, or more aggressive treatment for true progression. Currently standard medical practise is to administer a prophylactic treatment of chemotherapy to all patients with PTRIC with a follow up scan 3-6 months after initial PTRIC diagnosis, leading to up to 50% of patients receiving an unneeded dose of chemotherapy. The investigators hope to take advantage of the differentiation in tissue types and vascularization between true progression tumour and pseudoprogression to be able to identify patients who would not need to be administered a prophylactic dose of chemotherapy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • The subject must consent to participate.
  • The subject must be above the age of
  • Patients must be classified as possible pseudoprogression or true progression
  • Patients scoring >= 70 on the karnofsky performance status.

排除标准

  • Any subject with contraindication to an MRI procedure as listed in the Magnetic Resonance Environment Screening Questionnaire.
  • Any subject who may be unable to tolerate the MRI environment due to physical size and/or known tendency to claustrophobia.
  • Any subject who does not expect to be available to attend the for the required study MRI scans
  • Patients scoring < 70 on the karnofsky performance status.
  • Attending radiation oncologist or neurologist determines patient is no longer able to consent for themselves.

结局指标

主要结局

Disease Progression

时间窗: 6 months

R2\* and susceptibility-weighted imaging venography to determine retrospectively if pseudoprogression can be distinguished from true progression

次要结局

未报告次要终点

研究者

发起方
Centre for Functional and Metabolic Mapping
申办方类型
Other
责任方
Sponsor

研究点 (1)

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