EUCTR2015-005573-21-HU进行中（未招募）1 期
Exploratory phase II study in patients after treatment of high grade brain tumors to assess the technical performance of Tc-99m tetrofosmin for differentiation of recurrence versus radiation necrosis - GLIOMARK1
pro-ACTINA S.A.0 个研究点目标入组 51 人开始时间: 2016年6月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. confirmed high grade glioma (e.g., anaplastic astrocytoma, glioblastoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma)
- •2. being in follow-up for at least 3 months after completion of radiation therapy (with or without concurrent chemotherapy)
- •3. inconclusive MRI results regarding the differentiation between recurrence and radiation necrosis
- •4. willing and able to undergo all study procedures
- •5. informed consent in writing (dated and signed)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •1. age: less than18 years
- •2. if female, pregnant or breast feeding (females of child-bearing potential must use adequate contraception and must have a negative pregnancy test performed within 7 days prior to inclusion into this study)
- •3. contraindications for Tc-99m tetrofosmin
- •4. contraindications for F-18 FDG
- •5. close affiliation with the investigational site; e.g. first-degree relative of the investigator
- •6. participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
- •7. having been previously enrolled in this clinical trial
- •8. being mentally disabled
- •9. mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
研究者
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