<b>Safety and Efficacy of Photodynamic Therapy using Talaporfin Sodium and Diode Laser for Malignant Glioma: Report of Investigator Initiated Clinical Tria</b><b>l </b>

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  • Akimoto Jiro
    Department of Neurosurgery, Tokyo Medical University
  • Muragaki Yoshihiro
    Faculty of Advanced Techno-Surgery, Institute of Advanced Biomedical Engineering and Science, Tokyo Women’s Medical University
  • Maruyama Takashi
    Department of Neurosurgery, Tokyo Women’s Medical University
  • Ikuta Soko
    Faculty of Advanced Techno-Surgery, Institute of Advanced Biomedical Engineering and Science, Tokyo Women’s Medical University
  • Iseki Hiroshi
    Faculty of Advanced Techno-Surgery, Institute of Advanced Biomedical Engineering and Science, Tokyo Women’s Medical University

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  • 悪性脳腫瘍に対するレザフィリン<sup>® </sup>を用いた光線力学的治療 〜日本初の医薬品・医療機器複合型医師主導治験〜

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To investigate the safety and efficacy of photodynamic therapy (PDT) using talaporfin sodium and diode laser in patients with malignant gliomas. Subjects consisted of consecutive 27 adult patients with malignant gliomas. PDT was used as additional intraoperative treatment 24 hours after 40 mg/m2 of talaporfin sodium had been injected intravenously. After the tumor bulk had been resected as extensively as possible either 1 or 2 sites of probable tumor invasion in the bottom of resection cavity were irradiated superficially with a 664 nm diode laser for 27 J/cm2 at a power density of 150 mW/cm2. In glioblastoma patients, the median survival time was 24.8 months and 1 year survival rate was 100%. No adverse events directly attributable to PDT occurred in any patients. Protection against light was only required for 8 days after PDT. PDT in addition to surgical resection achieved better therapeutic results than conventional protocols, especially in patients with glioblastoma.

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