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临床试验/NCT02391246
NCT02391246Unknown不适用

A Dual Time Point FDG-PET to Differentiate Between Recurrent Brain Tumor and Radionecrosis

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
62
试验地点
1
主要终点
sensitivity and specificity percentages

研究概览

简要总结

Gliomas are the most common malignant primary central nervous system (CNS) tumours. When high-grade gliomas (HGG) recur, subsequent magnetic resonance (MRI) imaging, with additional sequences is required.The Positron Emission Tomography (PET) radiotracer [18F]-fluorodeoxyglucose (FDG) will be used in this study to distinguish between changes seen on MRI which can be a reflection of pseudoprogression, radiation necrosis, or recurrence.

详细描述

Molecular imaging has been used to distinguish recurrent tumor from post-treatment changes through the use of positron emission tomography (PET) as well as other techniques. The best-studied PET radiotracer for this application is [18F]-fluorodeoxyglucose (FDG). Normal brain matter is very FDG-avid, making it more difficult to identify lesions and in addition, inflammation associated with radiation injury has been shown to be FDG avid.

In light of this, variations of the standard FDG protocols have been proposed in order to increase overall accuracy, including dual time point imaging (DTPI), consisting of injecting the patient with the standard radiotracer and acquiring two sets of images several hours apart, typically the normal initial images in addition to a delayed acquisition set.

There is good reason to suspect that DTPI FDG-PET would be useful a technique for characterizing lesions in the brain. It's been shown that FDG uptake by normal brain parenchyma initially increases then decreases with time, while tumor uptake typically increases and then plateaus. This pattern of increasing and then decreasing FDG activity has also been seen in inflammatory tissue. The difference in FDG uptake at different times is what allows for a better distinction between malignant and benign tissue.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Age ≥ 18 years old
  • Able and willing to comply with the study procedures
  • The patient must be followed at The Ottawa Hospital for a tissue-proven, grade III or IV glioma.
  • The patient must have been treated in the past with radiotherapy for glioma.
  • A disease recurrence is suspected based on clinical symptoms and/or imaging results.

排除标准

  • Missing information regarding tumor type and grade
  • Brain biopsy in the ten days preceding DTPI FDG-PET
  • Breastfeeding or pregnancy
  • Claustrophobia or inability to lie still in a supine position
  • Unwillingness or inability to provide informed consent

结局指标

主要结局

sensitivity and specificity percentages

时间窗: 3 years

The sensitivity and specificity of dual time point imaging (DTPI) FDG-PET/CT will be compared to the sensitivity and specificity of MR imaging obtained as standard of care for identifying glioma recurrence post-treatment.

次要结局

  • Cost efficiency analysis(3 years)

研究者

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

Lionel Zuckier

Principal Investigator

Ottawa Hospital Research Institute

研究点 (1)

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