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Development of Computational Clinical Trial Mehtod for Laser Medicine

Research Project

Project/Area Number 19K22966
Research Category

Grant-in-Aid for Challenging Research (Exploratory)

Allocation TypeMulti-year Fund
Review Section Medium-sized Section 90:Biomedical engineering and related fields
Research InstitutionOsaka University

Principal Investigator

Awazu Kunio  大阪大学, 工学研究科, 教授 (30324817)

Co-Investigator(Kenkyū-buntansha) 西村 隆宏  大阪大学, 工学研究科, 助教 (10722829)
間 久直  大阪大学, 工学研究科, 准教授 (70437375)
Project Period (FY) 2019-06-28 – 2021-03-31
Project Status Completed (Fiscal Year 2020)
Budget Amount *help
¥6,500,000 (Direct Cost: ¥5,000,000、Indirect Cost: ¥1,500,000)
Fiscal Year 2020: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
Fiscal Year 2019: ¥4,420,000 (Direct Cost: ¥3,400,000、Indirect Cost: ¥1,020,000)
Keywords計算機臨床試験 / レーザー治療 / レギュラトリーサイエンス / 医療機器評価 / in silco試験 / 医療機器 / 光治療 / レーザー
Outline of Research at the Start

本研究では,光治療のための新規光学デバイスに対する安全性・有効性評価を計算的手法 にて実施するコンピュテーショナル臨床試験法を確立する.これまで物理空間で実施され ていた光治療における前臨床試験・臨床試験を計算機上で再現することにより,迅速・低コストな最先端光デバイスの臨床応用に向けた定量評価が可能となる.実現に向け,光治療の光照射条件に応じた光・生体組織相互作用の数理モデルの構築,高精度な数値パラメータ実測,臨床成果を活用した計算機的手法による確度向上により,確度の高い光治療シミュレータを実現する.

Outline of Final Research Achievements

This study proposed a computational clinical trial method to evaluate the safety and efficacy of novel laser devices for laser medicine. For this purpose, we constructed a computational phototherapy simulator that reproduces the treatment effects on the biological tissue using numerical methods. We also measured experimentally the optical properties of human skin tissue for use in the simulator. Using the simulator, we quantitatively compared the effects by several clinical laser devices to evaluate the safety from the viewpoint of thermal damage.

Academic Significance and Societal Importance of the Research Achievements

超短パルスレーザーなど,光学機器に関する技術進展は日進月歩であり,光治療のさらなる高度化や新たな治療法の創出につながる.ただし新規光学機器の臨床応用には,時間や費用コストが障壁となっている.これは臨床応用までのデバイスラグ・ギャップを生じさせるだけでなく,新規機器開発を躊躇させる要因となり,光治療分野の進展を妨げる.本研究で提案する光治療におけるコンピュテーショナル臨床試験では,これまで物理空間で実施されていた前臨床試験・臨床試験を計算機上で再現し,迅速・低コストな最先端光学機器の臨床適用に向けた評価手法を提供できる.

Report

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

    (10 results)

All 2021 2020 2019

All Journal Article (6 results) (of which Peer Reviewed: 6 results,  Open Access: 5 results) Presentation (4 results) (of which Int'l Joint Research: 1 results)

  • [Journal Article] Determination of optical properties in double integrating sphere measurement by artificial neural network based method2021

    • Author(s)
      Nishimura Takahiro、Takai Yusaku、Shimojo Yu、Hazama Hisanao、Awazu Kunio
    • Journal Title

      Optical Review

      Volume: 28 Issue: 1 Pages: 42-47

    • DOI

      10.1007/s10043-020-00632-6

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Incident Fluence Analysis for 755‐nm Picosecond Laser Treatment of Pigmented Skin Lesions Based on Threshold Fluences for Melanosome Disruption2021

    • Author(s)
      Shimojo Yu、Nishimura Takahiro、Hazama Hisanao、Ito Nobuhisa、Awazu Kunio
    • Journal Title

      Lasers in Surgery and Medicine

      Volume: - Issue: 8 Pages: 1096-1104

    • DOI

      10.1002/lsm.23391

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] A Method of Computational Clinical Trial of a Nanosecond Pulsed Laser Skin Treatment Device by Numerical Simulation of Photothermal Damage2020

    • Author(s)
      Nishimura Takahiro、Shimojo Yu、Hazama Hisanao、Awazu Kunio
    • Journal Title

      Nippon Laser Igakkaishi

      Volume: 40 Issue: 4 Pages: 301-308

    • DOI

      10.2530/jslsm.jslsm-40_0050

    • NAID

      130007785792

    • ISSN
      0288-6200, 1881-1639
    • Year and Date
      2020-01-15
    • Related Report
      2019 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Measurement of absorption and reduced scattering coefficients in Asian human epidermis, dermis, and subcutaneous fat tissues in the 400- to 1100-nm wavelength range for optical penetration depth and energy deposition analysis2020

    • Author(s)
      Shimojo Yu、Nishimura Takahiro、Hazama Hisanao、Ozawa Toshiyuki、Awazu Kunio
    • Journal Title

      Journal of Biomedical Optics

      Volume: 25 Issue: 04 Pages: 1-1

    • DOI

      10.1117/1.jbo.25.4.045002

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Fluorescence detection of deep intramucosal cancer excited by green light for photodynamic diagnosis using protoporphyrin IX induced by 5-aminolevulinic acid: an ex vivo study2020

    • Author(s)
      Ihara Daisuke、Hazama Hisanao、Nishimura Takahiro、Morita Yoshinori、Awazu Kunio
    • Journal Title

      Journal of Biomedical Optics

      Volume: 25 Issue: 06 Pages: 1-1

    • DOI

      10.1117/1.jbo.25.6.063809

    • Related Report
      2019 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Singlet oxygen model evaluation of interstitial photodynamic therapy with 5-aminolevulinic acid for malignant brain tumor2019

    • Author(s)
      Izumoto Atsuki、Nishimura Takahiro、Hazama Hisanao、Ikeda Naokado、Kajimoto Yoshinaga、Awazu Kunio
    • Journal Title

      Journal of Biomedical Optics

      Volume: 25 Issue: 06 Pages: 1-13

    • DOI

      10.1117/1.jbo.25.6.063803

    • Related Report
      2019 Research-status Report
    • Peer Reviewed / Open Access
  • [Presentation] Experimental analysis of morphological change in melanin for multiscale modeling of picosecond laser skin treatment2021

    • Author(s)
      Shimojo Yu、Nishimura Takahiro、Hazama Hisanao、Awazu Kunio
    • Organizer
      SPIE BiOS
    • Related Report
      2020 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 双積分球光学系と逆モンテカルロ法に基づいた表皮, 真皮, 皮下脂肪の光学特性値計測2020

    • Author(s)
      下条裕, 西村隆宏, 間久直, 小澤俊幸, 粟津邦男
    • Organizer
      レーザー学会学術講演会第40回年次大会
    • Related Report
      2019 Research-status Report
  • [Presentation] QスイッチNd:YAGレーザーによるダブルパルス照射が皮膚組織に及ぼす熱影響のin silico評価,2019

    • Author(s)
      下条裕, 西村隆宏, 間久直, 粟津邦男
    • Organizer
      第40回日本レーザー医学会総会
    • Related Report
      2019 Research-status Report
  • [Presentation] 計算機シミュレーションに基づいたレーザー治療のレギュラトリーサイエンス2019

    • Author(s)
      下条裕, 粟津邦男
    • Organizer
      第7回レーザー学会「レーザーバイオ医療」技術専門委員会
    • Related Report
      2019 Research-status Report

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Published: 2019-07-04   Modified: 2022-01-27  

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