High-intensity Focused Ultrasound (HIFU) for the Symptom Relief of Inoperable Abdominal Tumors (HIFU)
To Evaluate the Safety and Efficacy of High-intensity Focused Ultrasound (HIFU) for the Symptom Relief of Inoperable Abdominal Tumors
調査の概要
詳細な説明
The clinical recommendations for unresectable malignant tumors, which cause pain and other symptoms, are chemotherapy or local radiation therapy to delay tumor progression, improve life quality and prolong survival, while there is no other effective recommendations for benign tumors., Local ablation, such as radiofrequency ablation (RFA), is expected to be another therapeutic option for tumors that cannot be surgically resected. However, the main drawback of radiofrequency ablation is that its puncture invasion can sometimes cause bleeding or tumor metastasis. The peripheral blood vessels can also cause poor ablation, therefore; RFA is limited to small liver cancer treatment.
High-intensity focused ultrasound (HIFU), a recently developed tumor ablation equipment, can be a non-invasive treatment for solid tumors. The principle of HIFU is physically focus the ultrasound point on the biological tissue to form high-intensity ultrasound focus, and kill tumor cells by the thermal effects, mechanical effects and acupuncture effects of the high-intensity ultrasound.
Under the real-time magnetic resonance imaging system and a variety of appropriate scanning to move the focused ultrasound in the treatment area to kill the tumor. The tumor that is killed will gradually absorb and fibrosis in the body. There is no significant invasion due to it is without penetrating the needle into body. This system has been approved and certificated for the use of soft tissue ablation by Taiwan Food and Drug Administration (TFDA) in 2016. The main participants of this study are patients who have benign and malignant tumors in the abdominal cavity with tumor-related symptoms and not suitable for surgical resection. The investigators will conduct HIFU, observe whether there is any complications after surgery. Moreover, the investigators will notice the tumor response after a month and track the survival rate to verify the feasibility and advantages of HIFU for clinical use.
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
研究連絡先
- 名前：Kai-Wen Huang, MD, PhD
- 電話番号：+886-23123456
- メール：cubewu@gmail.com
研究場所
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Taipei、台湾
- 募集
- National Taiwan University Hospital
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コンタクト：
- Kai-Wen Huang, MD, PhD
- メール：skywing@ntuh.gov.tw
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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:
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Patients must meet all of the following inclusion criteria to be eligible for this study:
- Eligible patients with symptomatic intra-abdominal tumor including liver, pancreas, bile duct and retroperitoneal tumors will be enrolled for study.
- The criteria for unresectability included evidence of distant metastatic disease, involvement of the major vessels and high risk of functional insufficiency after tumor excision.
- Eastern Cooperative Oncology Group (ECOG) score of 0-1,
- American Society of Anaesthesiologists (ASA) score ≤ 3,
- Adequate bone marrow, liver and renal function (1). Platelet count ≥ 100 K/Μl(2). Total bilirubin ≦ 5 mg/dL(3). Alanine transaminase (ALT) and aspartate transaminase (AST) < 5 x upper limit of normal (4). Prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0 (5). Serum creatinine ≦ 2 x upper limit of normal
- Prior Informed Consent Form
- Life expectancy of at least 3 months.
Exclusion Criteria:
Patients presenting with any of the following will not be enrolled into this study:
- The tumor cannot be visualized by abdominal MRI.
- No suitable approach route for ultrasound toward tumor under image evaluation, for example scar formation, bowel gas, bone within the ultrasound window.
- Women who are pregnant.
- The patients had received treatment with an investigational agent/ procedure within 30 days prior to this study.
- Arterial calcification was noted within the treatment window of ultrasound.
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
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実験的：High-intensity focused ultrasound therapy
Abdominal MRI will be used to target the tumor, and the tumor will be divided into slices with 5mm separation using MR images.
By scanning the HIFU beam in successive sweeps from the deep to the shallow regions of the tumor.
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Local tumor ablation by ArcBlate (EpiSonica, Taiwan) will be performed, and the entire procedure will be monitored by MRI
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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 |
|---|---|---|
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Evaluation of tumour response
時間枠：1 month after treatment
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Evaluation of tumour response according to the modified RECIST criteria by sequencing CT or MR imaging
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1 month after treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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To evaluate the overall survival
時間枠：within one year
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using Common Terminology Criteria for Adverse Events (CTCAE).
Version 4.0 and overall survival
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within one year
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協力者と研究者
捜査官
- 主任研究者：Kai-Wen Huang, MD, PhD、National Taiwan University Hospital
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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