Clinical trial NCT04490954: The Accuracy of Brain Biological Electrical Impedance Tomography Screen for Supratentorial Tumors
Official title: A Prospective, Self-paired, Single-center Clinical Trial Evaluating the Accuracy of Brain Biological Electrical Impedance Tomography Screen for Supratentorial Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Tumor
Brain Edema
Keywords: Electrical Impedance Tomography
Supratentorial Brain Tumors
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 18 ≤70 years old, male or female;
2. Preoperative patients who had been diagnosed with supratentorial tumors by MRI/CT or other conventional methods or healthy people (23 cases each);
3. The longest diameter of the brain tumor is ≥3 cm;
4. Informed Consent Has been signed

Exclusion Criteria:

1. Severe systemic compound injury or hemorrhagic shock;
2. Epilepsy, poisoning symptoms;
3. In critical condition;
4. Patients with brain wounds or acute inflammation;
5. Lactation and pregnant women;
6. Those who have no informed consent ability or cannot sign by themselves;
7. The investigator considers it inappropriate for the patient to participate in this clinical trial

Primary outcomes:
measure: The AUC of ROC curve of the maximum increased value of impedance
timeFrame: 1 year
Secondary outcomes:
measure: the difference between the left and right equilibrium
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Jianmin Zhang
state: Zhejiang
Study officials:
affiliation: Department of neurosurgery
name: 1 year 1 year, M.D.
role: PRINCIPAL_INVESTIGATOR
References: