The Accuracy of Brain Biological Electrical Impedance Tomography Screen for Supratentorial Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Self-paired, Single-center Clinical Trial Evaluating the Accuracy of Brain Biological Electrical Impedance Tomography Screen for Supratentorial Tumors

Conditions
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Brain Tumor, Brain Edema

Intervention / Treatment
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* Device: brain biological electrical impedance tomography
* Device: MRI/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients examined with MRI/CT<br> | Device: MRI/CT<br>* Patients diagnosed with brain supratentorial tumors through MRI/CT<br>|
| Other: Patients examined with biological electrical impedance<br> | Device: brain biological electrical impedance tomography<br>* Patients diagnosed with brain supratentorial tumors through MRI/CT are evaluated with brain biological electrical impedance tomography. And the brain biological electrical impedance tomography is used to monitor the cerebral edema situation of patients with brain edema<br>Device: MRI/CT<br>* Patients diagnosed with brain supratentorial tumors through MRI/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The AUC of ROC curve of the maximum increased value of impedance | The AUC of ROC curve of the maximum increased value of impedance | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference between the left and right equilibrium | the difference between the left and right equilibrium | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical Impedance Tomography, Supratentorial Brain Tumors