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

Brain Tumor Clinical Trial

— ABST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04490954
• Other study ID #: IR2019001127
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Edema
• Brain Neoplasms
• Brain Tumor
• Supratentorial Neoplasms

Intervention

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
• MRI/CT
Patients diagnosed with brain supratentorial tumors through MRI/CT

Locations

Country	Name	City	State
China	Jianmin Zhang	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the difference between the left and right equilibrium	the difference between the left and right equilibrium	1 year