CTRI/2019/01/017325尚未招募2 期
Fluorescein guided surgery for resection of malignant glioma: A randomised control trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Proportion of patients with histologically confirmed malignant glioma on neuropathological review without residual contrast-enhancing tumour on postoperative MRI, and progression-free survival at 6 months
研究概览
简要总结
We aim to do a randomised controlled trial toassess the use of fluorescence inmalignant glioma after administration of Sodium Fluorescein improving resectionas defined by postoperative MRI, and to analyse the effect of resection on progressionfree survival and neurological morbidity
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 72.00 Year(s)（—）
- 性别
- All
入选标准
- •newly diagnosed, untreated suspected high grade glioma and who are eligible for surgery according to the study surgeon.
排除标准
- •tumours of the midline, basal ganglia, cerebellum, or brain stem as assessed by MRI
- •more than one contrast-enhancing lesion
- •substantial, non-contrast enhancing tumour areas suggesting low-grade glioma with malignant trans formation 4.medical reasons precluding MRI (eg, pacemaker, metallic implants)
- •inability to give consent because of dysphasia or language barrier 6.tumour location did not enable complete resection of contrast-enhancing tumour as decided by individual study surgeon;
- •renal insufficiency 9.hepatic insufficiency 10.history of malignant tumours at any other body site.
结局指标
主要结局
Proportion of patients with histologically confirmed malignant glioma on neuropathological review without residual contrast-enhancing tumour on postoperative MRI, and progression-free survival at 6 months
时间窗: 6 months
次要结局
- 1.Residual tumour volume on postoperative MRI(2.Overall survival)
研究者
研究点 (1)
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