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

Zhejiang University logo

Zhejiang University

Status

Unknown

Conditions

Brain Edema
Brain Tumor

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04490954
IR2019001127

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

46 participants in 2 patient groups

Patients examined with MRI/CT
Other group
Treatment:
Device: MRI/CT
Patients examined with biological electrical impedance
Other group
Treatment:
Device: brain biological electrical impedance tomography
Device: MRI/CT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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