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

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

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.

Study Overview

• Status: Unknown
• Conditions: Brain Tumor; Brain Edema
• Intervention / Treatment: Device: MRI/CT; Device: brain biological electrical impedance tomography

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.

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Jianmin Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients examined with MRI/CT	Device: MRI/CT; Patients diagnosed with brain supratentorial tumors through MRI/CT
Other: Patients examined with biological electrical impedance	Device: MRI/CT; Patients diagnosed with brain supratentorial tumors through MRI/CT; Device: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: 1 year 1 year, M.D., Department of Neurosurgery

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 19, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 26, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Electrical Impedance Tomography; Supratentorial Brain Tumors
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms; Brain Edema; Supratentorial Neoplasms
• Other Study ID Numbers: IR2019001127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No