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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04490954
Acronym
ABST
Enrollment
46
Registered
2020-07-29
Start date
2019-08-01
Completion date
2020-12-31
Last updated
2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Edema, Brain Tumor

Keywords

Electrical Impedance Tomography, Supratentorial Brain Tumors

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.

Interventions

DEVICEbrain 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

DEVICEMRI/CT

Patients diagnosed with brain supratentorial tumors through MRI/CT

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The AUC of ROC curve of the maximum increased value of impedance1 yearThe AUC of ROC curve of the maximum increased value of impedance

Secondary

MeasureTime frameDescription
the difference between the left and right equilibrium1 yearthe difference between the left and right equilibrium

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026