NL-OMON52545撤回不适用
The BIOPSY-trial: Biopsy versus Resection in Elderly Glioblastoma Patients. A prospective cohort study. - The BIOPSY-trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 325
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 65 至 99（—）
入选标准
- •1. Age >=70 years
- •2. Tumor diagnosed as glioblastoma on MRI with distinct ring-like pattern of
- •contrast enhancement with thick irregular walls and a core area reduced signal
- •suggestive of tumor necrosis as assessed by the surgeon.
- •3. Karnofsky Performance Score (KPS) >=70
- •4. Written Informed consent
排除标准
- •1. Tumors of the cerebellum, brain stem or midline
- •2. Multifocal contrast enhancing lesions
- •3. Substantial non-contrast enhancing tumor areas suggesting low grade gliomas
- •with malignant transformation
- •4. Medical reasons precluding MRI (e.g. pacemaker)
- •5. Inability to give consent as assessed by neurosurgeon (e.g. language barrier)
- •6. Severe aphasia prohibiting neurolinguistic testing and comprehension of
- •informed consent
- •7. Previous brain tumor surgery
- •8. Previous low-grade glioma
- •9. Second primary malignancy within the past 5 years with the exception of
- •adequately treated in situ carcinoma of any organ or basal cell carcinoma of
研究者
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