| Japanese |
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| Title | 99mTc-ECDの第II相臨床試験 - 10施設による共同研究 - |
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| Subtitle | 原著 |
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| Authors | 米倉義晴*, 佐々木康人**, 久保敦司***, 棚田修二****, 百瀬敏光**, 鳥塚莞爾***** |
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| Authors(kana) | |
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| Organization | *京都大学医学部脳病態生理学講座, **東京大学医学部附属病院放射線科, ***慶應義塾大学病院放射線科, ****愛媛大学医学部附属病院放射線科, *****福井医科大学 |
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| Journal | 核医学 |
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| Volume | 29 |
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| Number | 9 |
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| Page | 1113-1125 |
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| Year/Month | 1992/9 |
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| Article | 原著 |
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| Publisher | 日本核医学会 |
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| Abstract | 「要旨」新しい局所脳血流イメージング剤である99mTc-ECDの安全性, 有効性, 有用性, 至適投与量および至適撮像時期の検討を目的とし, 脳血管障害, 脳機能障害患者166例を対象に全国10施設の共同により第II相臨床試験を実施した. 本剤の安全性は投与全例について「安全性に問題なし」と判定され, 本剤に起因すると思われる副作用は認められなかった. 163例中160例(98.2%)において臨床診断に有効な情報が得られ, 154例(94.5%)が「きわめて有用」または「有用」と判定された. 撮像開始は投与5分以降より可能であるが, 投与後60〜90分の画像が相対的に優れている例が多かった. 標準的な臨床投与量は400〜800MBqが適当と考えられた. 本剤は局所脳血流イメージング剤として有望な放射性医薬品であると考えられた. |
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| Practice | 臨床医学：一般 |
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| Keywords | 99mTc-ECD, Brain, SPECT, Regional cerebral blood flow. |
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| English |
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| Title | Phase 2 Clinical Study of 99mTc-ECD - A Multicenter Study - |
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| Subtitle | |
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| Authors | Yoshiharu YONEKURA*, Yasuto SASAKI**, Atsushi KUBO***, Shuji TANADA****, Toshimitsu MOMOSE**, Kanji TORIZUKA***** |
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| Authors(kana) | |
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| Organization | *Department of Brain Pathophysiology, Faculty of Medicine, Kyoto University, **Department of Radiology, Faculty of Medicine, University of Tokyo, ***Department of Radiology, Keio University Hospital, ****Department of Radiology, Faculty of Medicine, Ehime University, *****Fukui Medical School |
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| Journal | The Japanese Journal of nuclear medicine |
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| Volume | 29 |
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| Number | 9 |
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| Page | 1113-1125 |
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| Year/Month | 1992/9 |
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| Article | Original article |
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| Publisher | THE JAPANESE SOCIETY OF NUCLEAR MEDICINE |
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| Abstract | [Summary] A phase 2 clinical study of a newly developed brain perfusion agent, 99mTc-ECD, was performed in 166 cases of cerebrovascular diseases and impairment of brain function to evaluate effectiveness, usefulness, optimum dose and optimum timing of imaging as a multi-center study involving 10 institutions in Japan. All cases were judged as no problems on safety and any side effects due to the administration of the compound were not observed. Out of 163 cases evaluated for the clinical usefulness, valuable information for clinical diagnosis was obtained in 160 cases (98.3%), and 154cases (94.5%) were judged as "extremely useful" or "useful". Although SPECT imaging was possible from 5 min after injection, images obtained between 60 and 90 min after injection showed relatively better image quality in many cases. Regarding standard administration dose, 400 to 800 MBq were considered to be appropriate. 99mTc-ECD is considered to be a promising radiopharmaceutical as a brain perfusion agent. |
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| Practice | Clinical medicine |
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| Keywords | 99mTc-ECD, Brain, SPECT, Regional cerebral blood flow. |
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