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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04490954
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor; Brain Edema	Device: brain biological electrical impedance tomography; Device: MRI/CT	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 46 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Prospective, Self-paired, Single-center Clinical Trial Evaluating the Accuracy of Brain Biological Electrical Impedance Tomography Screen for Supratentorial Tumors
• Actual Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

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: 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; Device: MRI/CT; Patients diagnosed with brain supratentorial tumors through MRI/CT

Outcome Measures

Primary Outcome Measures

1. The AUC of ROC curve of the maximum increased value of impedance [1 year]

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

Secondary Outcome Measures

1. the difference between the left and right equilibrium [1 year]

   the difference between the left and right equilibrium

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jianmin Zhang	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

• Principal Investigator: 1 year 1 year, M.D., Department of neurosurgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04490954
• Other Study ID Numbers: IR2019001127
• First Posted: Jul 29, 2020
• Last Update Posted: Jul 29, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University: Electrical Impedance Tomography; Supratentorial Brain Tumors
• Additional relevant MeSH terms: Brain Neoplasms; Supratentorial Neoplasms; Brain Edema

Study Results

No Results Posted as of Jul 29, 2020