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First-in-Human trial of CT fluoroscopy-guided biopsy using a remote controllable robot for needle insertion

Research Project

Project/Area Number 18K07677
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 52040:Radiological sciences-related
Research InstitutionOkayama University

Principal Investigator

Hiraki Takao  岡山大学, 医歯薬学総合研究科, 研究教授 (50423322)

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)
Project Period (FY) 2018-04-01 – 2021-03-31
Project Status Completed (Fiscal Year 2020)
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)
KeywordsInterventional 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
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.

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。

Report

(4 results)
  • 2020 Annual Research Report   Final Research Report ( PDF )
  • 2019 Research-status Report
  • 2018 Research-status Report
  • Research Products

    (7 results)

All 2021 2020 2019

All Journal Article (1 results) (of which Peer Reviewed: 1 results) Presentation (6 results) (of which Invited: 5 results)

  • [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.
    • Journal Title

      European Radiology

      Volume: 30 Issue: 2 Pages: 927-933

    • DOI

      10.1007/s00330-019-06409-z

    • Related Report
      2019 Research-status Report
    • Peer Reviewed
  • [Presentation] CTガイド下IVR用針穿刺ロボット(Zerobot)の開発2021

    • Author(s)
      平木隆夫
    • Organizer
      先端総合イメージングセミナー
    • Related Report
      2020 Annual Research Report
    • Invited
  • [Presentation] 岡山発のがんの低侵襲治療用の針穿刺ロボット(Zerobot)の開発:医師主導治験までの道のり2021

    • Author(s)
      平木隆夫
    • Organizer
      岡山県医用工学研究会
    • Related Report
      2020 Annual Research Report
    • Invited
  • [Presentation] CTガイド下IVR用針穿刺ロボットの開発2020

    • Author(s)
      平木隆夫
    • Organizer
      日本生体医工学学会大会
    • Related Report
      2020 Annual Research Report
    • Invited
  • [Presentation] CTガイド下肺生検 ~最新の研究も含めて~2020

    • Author(s)
      平木隆夫
    • Organizer
      日本肺癌学会
    • Related Report
      2020 Annual Research Report
    • Invited
  • [Presentation] CTガイド下IVR用穿刺ロボット(Zerobot)の開発2020

    • Author(s)
      平木隆夫
    • Organizer
      日本脳神経外科学会
    • Related Report
      2020 Annual Research Report
    • Invited
  • [Presentation] ロボット(Zerobot)を用いたCT透視ガイド下生検:前向き、ファーストインマン、実行可能性試験2019

    • Author(s)
      平木隆夫、亀川哲志、松野隆幸、櫻井 淳小牧稔幸、冨田晃司、松井裕輔、郷原英夫、金澤 右
    • Organizer
      第78回日本医学放射線学会総会
    • Related Report
      2019 Research-status Report

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Published: 2018-04-23   Modified: 2022-01-27  

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