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

NCT ID: NCT04490954

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-12-31

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.

Conditions

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Brain Tumor Brain Edema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients examined with MRI/CT

Group Type OTHER

MRI/CT

Intervention Type DEVICE

Patients diagnosed with brain supratentorial tumors through MRI/CT

Patients examined with biological electrical impedance

Group Type OTHER

brain biological electrical impedance tomography

Intervention Type DEVICE

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

MRI/CT

Intervention Type DEVICE

Patients diagnosed with brain supratentorial tumors through MRI/CT

Interventions

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brain biological electrical impedance tomography

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

Intervention Type DEVICE

MRI/CT

Patients diagnosed with brain supratentorial tumors through MRI/CT

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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1 year 1 year, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of neurosurgery

Locations

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Jianmin Zhang

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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IR2019001127

Identifier Type: -

Identifier Source: org_study_id

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