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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310000
- Jianmin Zhang
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Patients examined with MRI/CT
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Patients diagnosed with brain supratentorial tumors through MRI/CT
|
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他の：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The AUC of ROC curve of the maximum increased value of impedance
時間枠：1 year
|
The AUC of ROC curve of the maximum increased value of impedance
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
the difference between the left and right equilibrium
時間枠：1 year
|
the difference between the left and right equilibrium
|
1 year
|
協力者と研究者
捜査官
- 主任研究者：1 year 1 year, M.D.、Department of Neurosurgery
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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