A Prospective, Self-paired, Single-center Clinical Trial Evaluating the Accuracy of Brain Biological Electrical Impedance Tomography Screen for Supratentorial Tumors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The AUC of ROC curve of the maximum increased value of impedance
研究概览
简要总结
Compared with MRI or CT, brain biological electrical impedance tomography were performed on patients with supratentorial tumors and healthy people . The AUC (area under the curve) of ROC, which is associated with the increased maximum and the difference between left and right equilibrium of impedance value, is calculated. The specificity of brain biological electrical impedance tomography in screening supratentorial tumors are evaluated.
To compare the changes of parameters detected by brain biological electrical impedance tomography, the enrolled brain tumor patients with cerebral edema were paired with themselves and intravenous infusion of mannitol so that the sensitivity of this device in monitoring cerebral edema can be evaluated.
详细描述
Compared with MRI or CT, brain biological electrical impedance tomography were performed on patients with supratentorial tumors and healthy people . The AUC (area under the curve) of ROC, which is associated with the increased maximum and the difference between left and right equilibrium of impedance value, is calculated. The specificity of brain biological electrical impedance tomography in screening supratentorial tumors are evaluated.
To compare the changes of parameters detected by brain biological electrical impedance tomography, the enrolled brain tumor patients with cerebral edema were paired with themselves and intravenous infusion of mannitol so that the sensitivity of this device in monitoring cerebral edema can be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 ≤70 years old, male or female;
- •Preoperative patients who had been diagnosed with supratentorial tumors by MRI/CT or other conventional methods or healthy people (23 cases each);
- •The longest diameter of the brain tumor is ≥3 cm;
- •Informed Consent Has been signed
排除标准
- •Severe systemic compound injury or hemorrhagic shock;
- •Epilepsy, poisoning symptoms;
- •In critical condition;
- •Patients with brain wounds or acute inflammation;
- •Lactation and pregnant women;
- •Those who have no informed consent ability or cannot sign by themselves;
- •The investigator considers it inappropriate for the patient to participate in this clinical trial
研究组 & 干预措施
Patients examined with MRI/CT
干预措施: MRI/CT (Device)
Patients examined with biological electrical impedance
干预措施: brain biological electrical impedance tomography (Device)
Patients examined with biological electrical impedance
干预措施: MRI/CT (Device)
结局指标
主要结局
The AUC of ROC curve of the maximum increased value of impedance
时间窗: 1 year
The AUC of ROC curve of the maximum increased value of impedance
次要结局
- the difference between the left and right equilibrium(1 year)