NCT02971319已完成2 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
Proactina S.A.10 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 10
- 主要终点
- Technical performance of Tc-99m tetrofosmin SPECT
研究概览
简要总结
This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an intra-individual comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed high grade glioma (e.g., anaplastic astrocytoma, glioblastoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma)
- •being in follow-up for at least 3 months after completion of radiation therapy (with or without concurrent chemotherapy)
- •inconclusive MRI results regarding the differentiation between recurrence and radiation necrosis
- •willing and able to undergo all study procedures
- •informed consent in writing (dated and signed)
排除标准
- •age: less than18 years
- •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)
- •contraindications for Tc-99m tetrofosmin
- •contraindications for F-18 FDG
- •close affiliation with the investigational site; e.g. first-degree relative of the investigator
- •participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
- •having been previously enrolled in this clinical trial
- •being mentally disabled
- •mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
- •Being clinically unstable or requiring emergency treatment
结局指标
主要结局
Technical performance of Tc-99m tetrofosmin SPECT
时间窗: assessed once within 3 weeks of inclusion
次要结局
未报告次要终点
研究者
研究点 (10)
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