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

Primary Purpose

Brain Tumor, Brain Edema

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
brain biological electrical impedance tomography
MRI/CT
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumor focused on measuring Electrical Impedance Tomography, Supratentorial Brain Tumors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jianmin Zhang

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients examined with MRI/CT

Patients examined with biological electrical impedance

Arm Description

Outcomes

Primary Outcome Measures

The AUC of ROC curve of the maximum increased value of impedance
The AUC of ROC curve of the maximum increased value of impedance

Secondary Outcome Measures

the difference between the left and right equilibrium
the difference between the left and right equilibrium

Full Information

First Posted
July 19, 2020
Last Updated
July 26, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04490954
Brief Title
The Accuracy of Brain Biological Electrical Impedance Tomography Screen for Supratentorial Tumors
Acronym
ABST
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Brain Edema
Keywords
Electrical Impedance Tomography, Supratentorial Brain Tumors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients examined with MRI/CT
Arm Type
Other
Arm Title
Patients examined with biological electrical impedance
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
brain biological electrical impedance tomography
Intervention Description
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
Intervention Name(s)
MRI/CT
Intervention Description
Patients diagnosed with brain supratentorial tumors through MRI/CT
Primary Outcome Measure Information:
Title
The AUC of ROC curve of the maximum increased value of impedance
Description
The AUC of ROC curve of the maximum increased value of impedance
Time Frame
1 year
Secondary Outcome Measure Information:
Title
the difference between the left and right equilibrium
Description
the difference between the left and right equilibrium
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 ≤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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
1 year 1 year, M.D.
Organizational Affiliation
Department of neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jianmin Zhang
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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