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临床试验/NCT01923922
NCT01923922已完成不适用

CT Perfusion in the Prognostication of Cerebral High Grade Glioma

Nova Scotia Health Authority2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2013年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Survival of patients with high grade cerebral glioma based on the CT perfusion parameters irrespective of the pathological grade and irrespective of the treatment given.

研究概览

简要总结

High grade cerebral glioma is the most common primary brain tumor in adults and accounts for about 2.5% of all cancer deaths. Brain tumor affects approximately 2300 individuals per year in Canada. Noninvasive accurate and timely diagnosis is imperative.

High grade glioma is an aggressive neoplasm with median survival of 12 months, irrespective of any treatment. The prognosis of these patients can only be decided based on pathology after biopsy or surgery. Conventional imaging techniques, such as routine magnetic resonance imaging(MRI), do not accurately predict the grade of malignancy of cerebral gliomas. Computed tomography(CT) perfusion allows us to study the blood supply to the tumor at the level of capillaries. This information permits determination of aggressiveness of cerebral gliomas at the time of diagnosis.

In a preliminary study of 20 patients with high grade cerebral gliomas, we have shown that CT perfusion can predict survival at the time of diagnosis irrespective of the pathological grade and the treatment received. In the present study, we would like to extend our preliminary findings in larger group of patients to ensure that this technique is indeed robust. If our hypothesis was supported by our study, we will be able to subselect patients based on initial imaging for more aggressive treatment. In patients with shorter survival, the perfusion parameters may help in identifying new therapeutic targets (e.g., anti-angiogenic agents) that may help in the treatment of these patients.

详细描述

Purpose of the research: Evaluate the utility of the non-invasive imaging tool of computed tomography (CT) perfusion in preoperative prognostication of high grade cerebral gliomas.

Background information: Brain tumour affects approximately 2300 individuals per year in Canada. High grade glioma is the most common primary brain tumour in adults and accounts for approximately 2.5% of all cancer deaths. The real incidence of high grade glioma in the country is not known, but it affects approximately 2 per 100,000 people per year in Nova Scotia. Non-invasive, accurate and timely diagnosis is imperative.

High grade glioma is an aggressive neoplasm, and the median survival of affected patients is 12 months, irrespective of any form of treatment. The prognosis of these patients can only be determined on pathology after biopsy or surgery. Conventional imaging techniques such as as magnetic resonance imaging(MRI) alone do not help in predicting the level of malignancy of cerebral gliomas. Formation of new blood vessels plays a central role in the growth and spread of tumours. The advanced imaging tool of computed tomography(CT) perfusion can be used to study blood supply to the tumor at the level of capillaries. This information permits determination of aggressiveness of cerebral gliomas at the time of diagnosis.

To direct better and aggressive care in patients with high grade cerebral glioma, it is important to identify patients whose life expectancy could be relatively longer. The two high grades of gliomas have been grouped together in the literature for both treatment and prognosis. There are only a few studies that have addressed the differentiation of the two higher grades of gliomas. Some of these are our own preliminary studies. In a preliminary study of 20 such patients,investigators have shown that CT perfusion can predict survival, irrespective of the pathological grade and treatement received. In the present study, investigators would like to extend our preliminary findings in a larger group of patients to ensure that this technique is indeed robust. In patients with shorter survival, the perfusion parameters may help in identifying new therapeutic targets (e.g., anti-angiogenic agents) that may help in the treatment of these patients.

Both CT and MR perfusion studies can be used to assess the blood supply of brain tumors. MR perfusion is limited in terms of absolute quantification of the perfusion parameters due to the non-linear relationship between the concentration of contrast material and the signal intensity change. MR perfusion studies also require two bolus injections of contrast agents. CT perfusion is a widely available and reliable technique which can give absolute quantification of perfusion parameters with a single acquisition and single bolus of a contrast agent.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients, presenting with a newly detected brain lesion likely to be high grade cerebral glioma either on CT or MRI of the brain

排除标准

  • Pregnant patients
  • those with impaired renal function

结局指标

主要结局

Survival of patients with high grade cerebral glioma based on the CT perfusion parameters irrespective of the pathological grade and irrespective of the treatment given.

时间窗: 1 year

次要结局

  • Number of Adverse Events as a Measure of Safety and Tolerability(30 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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