成果報告書詳細
管理番号20110000001720
タイトル*平成22年度中間年報「がん超早期診断・治療機器の総合研究開発/超早期高精度診断システムの研究開発:画像診断システムの研究開発/がんの性状をとらえる分子プローブ等の研究開発(がんの特性識別型分子プローブ)」(日本メジフィジックス株式会社)
公開日2012/10/4
報告書年度2010 - 2010
委託先名日本メジフィジックス株式会社
プロジェクト番号P10003
部署名バイオテクノロジー・医療技術部
和文要約和文要約等以下本編抜粋:
1. 研究開発の内容及び成果等
本研究開発プロジェクトの目的は、PET を中心とし他の画像診断機器(SPECT、MRI)と組み合わせたマルチモダリティイメージングの手法により、がん分子標的治療薬の標的とする分子の発現・活性およびがんの性状を高効率的・多面的に捉え、効果的な治療法の決定に寄与することにある。本研究プロジェクトの協働実施機関である京都大学では、1)乳がん、2)前立腺がん、3)膵がん、を選択し、それぞれの病態メカニズムと治療法特性に立脚した新規プローブ開発および複数プローブの組み合わせ法の確立、さらに、MRI 画像との組み合わせについての検討を行っている。当社は、京都大学が開発した分子プローブの安全性評価法について適切な手法の調査・確立を行うとともに、動物を用いたインビボ実験に必要な最低限の生体安全性を評価、結果を分子設計にフィードバックし、分子プローブの最適化を図るとの役割を担っている。当該年度に当社が実施した研究開発の内容について、以下に報告する。
英文要約Title: The Advanced Research and Development Project on Diagnosis and Treatment for Early Stage of Cancer - Research and Development Project on High-speck Diagnostic Equipment for Medical Imaging - Research and Development Project on Medical Imaging System - Research and Development Project on Molecular Imaging Probes for Cancer Characterization - Molecular Imaging Probes for Cancer Characterization (FY2010-2012) FY2010 Annual Report

The goal of this R&D project is to develop the multi-modalities imaging methods, combining Positron Emission Tomography (PET) and other imaging devices such as MRI, for the purpose of optimizing the molecular-targeted cancer therapeutics in the personalized clinical settings. In collaboration with Kyoto University, we have decided to develop new PET imaging probes for (1) breast, (2) prostate and (3) pancreatic cancers. Molecular designs of these PET imaging probes would be based on pathophysiological properties and treatment strategies of each tumor. Nihon Medi-Physics (NMP) is in charge of preclinical safety evaluations of the new PET imaging probes to be developed by Kyoto University. This annual report briefly summarizes the R&D activities made by NMP for this project in fiscal year 2010. In FY2010, NMP collected some information regarding the safety requirements for the new PET imaging probes. Briefly, regulatory documents such as “Guidance for Microdose Clinical Trials” and “Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH-M3 R2)” were carefully reviewed. In addition, current activities on microdose clinical studies by Japanese clinical research institutes were surveyed from several medical conferences such as International Symposium of Early Stage Clinical Trial (January 2011 in Beppu), post-congress lectures of Japanese society of Clinical Pharmacology and Therapeutics (December 2010 in Kyoto), etc. Through these activities, the feasibility of microdose clinical studies in Japan has been conformed. However, it should be noted that several additional resources and supports should be required for promoting microdose clinical studies in Japan, especially in the field of regulatory process and supply chain of radio-labeled test materials. Preliminary market research for the new PET imaging probes in the area of breast, prostate and pancreatic cancers were also conducted. Clinical unmet needs in these tumors as well as recent developments of molecular targeted therapeutics were reviewed from many professional congresses such as Japanese Cancer Society (September 2010 in Osaka), Japanese Society of Nuclear Medicine (November 2010 in Omiya), Japanese Society for Therapeutic Radiology and Oncology (November 2010 in Maihama). It is concluded that the understandings on molecular mechanism of treatment-resistance is critical for designing and developing new PET imaging agents.
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