First-in-Human trial of CT fluoroscopy-guided biopsy using a remote controllable robot for needle insertion
| Project/Area Number |
18K07677
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Review Section |
Basic Section 52040:Radiological sciences-related
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| Research Institution | Okayama University |
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Principal Investigator |
Hiraki Takao 岡山大学, 医歯薬学総合研究科, 研究教授 (50423322)
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| Co-Investigator(Kenkyū-buntansha) |
金澤 右 岡山大学, 医歯薬学総合研究科, 教授 (20243511)
櫻井 淳 岡山大学, 大学病院, 准教授 (30444657)
小牧 稔幸 岡山大学, 大学病院, 医員 (40795548)
松野 隆幸 岡山大学, 自然科学研究科, 准教授 (50377842)
松井 裕輔 岡山大学, 大学病院, 講師 (50614351)
亀川 哲志 岡山大学, ヘルスシステム統合科学研究科, 准教授 (80432623)
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| Project Period (FY) |
2018-04-01 – 2021-03-31
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| Project Status |
Completed (Fiscal Year 2020)
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| Budget Amount *help |
¥4,420,000 (Direct Cost: ¥3,400,000、Indirect Cost: ¥1,020,000)
Fiscal Year 2020: ¥390,000 (Direct Cost: ¥300,000、Indirect Cost: ¥90,000)
Fiscal Year 2019: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2018: ¥2,340,000 (Direct Cost: ¥1,800,000、Indirect Cost: ¥540,000)
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| Keywords | Interventional radiology / ロボット / CTガイド / 生検 / First-in-Human試験 / 臨床試験 / インターベンショナルラジオロジー / IVR / 針穿刺 / CT透視ガイド下生検 / FIH試験 |
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| Outline of Final Research Achievements |
The trial was performed in 2018. Ten patients (4 females and 6 males; mean age, 72 years) with lesions (mean maximum diameter, 28 mm) in the kidney, lung, mediastinum, adrenal, and muscle were enrolled. In all patients, robotic insertion of the introducer needle was feasible; pathological diagnosis was made. There was no machine-related trouble. A total of 11 adverse events occurred in 8 patients, including 10 grade I events and 1 grade IIIa event. Any event was not deemed to be related with the use of the robot. Effective dose to physicians during robotic needle insertion was zero in all cases. The results of the trial were presented in the annual meeting of Japanese Radiology Society and published in European Radiology.
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| Academic Significance and Societal Importance of the Research Achievements |
CTガイド下IVRは、低侵襲で手技時間が短いのが利点であるが、CT装置の近くでCTを撮影しながら針を刺入するため、治療を行う医師は放射線被曝するという欠点がある。ロボットを遠隔操作してCTガイド下IVRを行うことで、術中の医師への被曝は解消した。この社会的意義は大きい。またこのような報告は世界的に見ても希少であり、学術的意義も大きい。ロボットで行う穿刺は、人の手で行う穿刺と異なり手ブレがなく、針の穿刺角度や穿刺深さを数値入力で制御可能であり、手技の半自動化も可能であり、その利点を活かせば、患者の被曝の減少や治療成績の向上など患者の利益も期待できる。
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Report
(4 results)
Research Products
(7 results)
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[Journal Article] Robotic Needle Insertion during Computed Tomography Fluoroscopy-guided Biopsy: Prospective First-in-Human Feasibility Trial.2020
Author(s)
Hiraki T, Kamegawa T, Matsuno T, Sakurai J, Komaki T, Yamaguchi T, Tomita K, Uka M, Matsui Y, Iguchi T, Gobara H, Kanazawa S.
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Journal Title
European Radiology
Volume: 30
Issue: 2
Pages: 927-933
DOI
Related Report
Peer Reviewed
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