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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310000
- Jianmin Zhang
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Patients examined with MRI/CT
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Patients diagnosed with brain supratentorial tumors through MRI/CT
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Andet: Patients examined with biological electrical impedance
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Patients diagnosed with brain supratentorial tumors through MRI/CT
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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The AUC of ROC curve of the maximum increased value of impedance
Tidsramme: 1 year
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The AUC of ROC curve of the maximum increased value of impedance
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1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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the difference between the left and right equilibrium
Tidsramme: 1 year
|
the difference between the left and right equilibrium
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1 year
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: 1 year 1 year, M.D., Department of Neurosurgery
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IR2019001127
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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