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

NCT04490954 | Unknown

• 1 other identifier: IR2019001127
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Brain Edema

Keywords

Electrical Impedance Tomography; Supratentorial Brain Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the difference between the left and right equilibrium

  1 year

Study Arms (2)

Patients examined with MRI/CT

OTHER

Device: MRI/CT

Patients examined with biological electrical impedance

OTHER

Device: brain biological electrical impedance tomography; Device: MRI/CT

Interventions

brain biological electrical impedance tomography 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

Patients examined with biological electrical impedance

MRI/CT DEVICE

Patients diagnosed with brain supratentorial tumors through MRI/CT

Patients examined with MRI/CT; Patients examined with biological electrical impedance

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Jianmin Zhang

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Brain Neoplasms; Brain Edema

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• 1 year 1 year, M.D.

  Department of neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 29, 2020
• Study Start: August 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)