| Japanese |
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| Title | 111In-DTPA-D-Phe-octreotideの消化管ホルモン産生腫瘍を対象とした第III相臨床試験 |
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| Subtitle | 技術報告 |
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| Authors | 山本和高1,**, 石井靖1, 古舘正從2, 伊藤和夫3, 塚本江利子3, 金丸龍之介4,**, 遠藤啓吾5,**, 平野恒夫5, 田中孝司6,**, 荻野良郎6, 宇野公一7, 久保敦司8,**, 橋本順8, 日下部きよ子9, 牧正子9, 佐々木康人10, 瀬戸光11, 利波紀久12, 石垣武男13, 中川毅14, 松下智人14, 小西淳二15,**, 阪原晴海15, 長谷川義尚16, 池窪勝治17, 渡邊祐司18, 濱本研19, 増田康治20, 中條政敬21, 中別府良昭21, 鳥塚莞爾* |
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| Authors(kana) | |
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| Organization | *治験総括医師 / 京都大学・福井医科大学名誉教授, **幹事, 1福井医科大学放射線科, 2北海道大学名誉教授, 3北海道大学医学部核医学科, 4東北大学加齢医学研究所癌化学療法研究分野, 5群馬大学医学部核医学科, 6帝京大学医学部第三内科, 7千葉大学医学部放射線科, 8慶應義塾大学医学部放射線科, 9東京女子医科大学放射線科, 10東京大学医学部放射線科, 11富山医科薬科大学医学部放射線科, 12金沢大学医学部核医学科, 13名古屋大学医学部放射線科, 14三重大学医学部放射線科, 15京都大学医学部核医学科, 16大阪府立成人病センターアイソトープ診療科, 17神戸市立中央市民病院核医学科, 18倉敷中央病院放射線科, 19愛媛大学医学部放射線科, 20九州大学医学部放射線科, 21鹿児島大学医学部放射線科 |
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| Journal | 核医学 |
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| Volume | 32 |
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| Number | 11 |
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| Page | 1269-1280 |
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| Year/Month | 1995/11 |
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| Article | 報告 |
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| Publisher | 日本核医学会 |
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| Abstract | 「要旨」ソマトスタチンレセプターへの結合性を有する新しい腫瘍イメージング剤111In-DTPA-D-Phe-Octreotide(111In-ペンテトレオチド, 開発コード : MP-1727)の有効性, 安全性および有用性の検討のため, 消化管ホルモン産生腫瘍患者23例を対象として多施設共同臨床試験を実施した. 本剤の有効性は評価対象21例中16例(76.2%)で「有効」以上と判定され, 各腫瘍の有病正診率はそれぞれカルチノイド77.8%(7/9), ガストリノーマ100%(5/5)およびインスリノーマ40.0%(2/5)であった. また, 3例で事前の画像診断では検出されなかった病巣が新たに確認された. 部位毎の他の画像診断との一致率は全体で82.0%(41/50部位)であった. 安全性については, 軽度の副作用が2例に認められたが, 全例で「全く問題がない」と判定された. 以上のことから本剤は安全で, 消化管ホルモン産生腫瘍の診断に非常に有用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 | 111In-DTPA-D-Phe-octreotide, Gastrointestinal hormone producing tumor, Somatostatin receptor. |
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| English |
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| Title | Phase 3 Multicenter Clinical Study of 111In-DTPA-D-Octreotide (MP-1727) in Patients with Gastrointestinal Hormone Producing Tumors |
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| Authors | Kazutaka YAMAMOTO1),**, Yasushi ISHII1), Masayori FURUDATE2), Kazuo ITO3), Eriko TSUKAMOTO3), Ryunosuke KANAMARU4),**, Keigo ENDO5),**, Tsuneo HIRANO5), Koshi TANAKA6),**, Yoshio OGINO6), Kimiichi UNO7), Atsushi KUBO8),**, Jun HASHIMOTO8), Kiyoko KUSAKABE9), Masako MAKI9), Yasuhito SASAKI10), Hikaru SETO11), Norihisa TONAMI12), Takeo ISHIGAKI13), Tsuyoshi NAKAGAWA14), Tomohito MATSUSHITA14), Junji KONISHI15),**, Harumi SAKAHARA15), Yoshihisa HASEGAWAl6), Katsuji IKEKUBO17), Yuji WATANABE18), Ken HAMAMOTO19), Koji MASUDA20), Masayuki NAKAJO21), Yoshiaki NAKABEPPU21), Kanji TORIZUKA* |
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| Authors(kana) | |
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| Organization | *Principal Investigator, Professor Emiritus, Kyoto University and Fukui Medical School, **Members of Executive Committee, 1)Department of Radiology, Fukui Medical School, 2)Professor Emiritus, Hokkaido University, 3)Department of Nuclear Medicine, Hokkaido University School of Medicine, 4)Institute of Development, Aging and Cancer, Tohoku University, 5)Department of Nuclear Medicine, Gunma University Schoo1 of Medicine, 6)Third Department of Medicine, Teikyo University School of Medicine, 7)Department of Radiology, Chiba University School of Medicine, 8)Department of Radiology, Keio University School of Medicine, 9)Department of Radiology, Tokyo Women's Medical College, 10)Department of Radiology, Tokyo University Faculty of Medicine, 11)Department of Radiology, Toyama Medical and Pharmaceutical University Faculty of Medicine, 12)Department of Nuclear Medicine, Kanazawa University School Medicine, 13)Department of Radiology, Nagoya University School of Medicine, 14)Department of Radiology, Mie University Faculty of Medicine, 15)Department of Nuclear Medicine, Kyoto University Faculty of Medicine, 16)Department of Nuclear Medicine, The Center for Adult Diseases, Osaka, 17)Department of Nuclear Medicine, Kobe City General Hospital, 18)Department of Radiology, Kurashiki Central Hospital, 19)Department of Radiology, Ehime University School of Medicine, 20)Department of Radiology, Kyushu University Faculty of Medicine, 21)Department of Radiology, Kagoshima University Faculty of Medicine |
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| Journal | The Japanese Journal of nuclear medicine |
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| Volume | 32 |
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| Number | 11 |
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| Page | 1269-1280 |
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| Year/Month | 1995/11 |
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| Article | Report |
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| Publisher | THE JAPANESE SOCIETY OF NUCLEAR MEDICINE |
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| Abstract | [Summary]A phase 3 multicenter clinical study was performed to investigate the efficacy, safety and usefulness of MP-1727, a novel tumor imaging agent which binds to somatostatin receptors, in 23 patients with gastrointestinal hormone producing tumor. The efficacy was graded effective or very effective in 16 cases (76.2%) out of 21 cases who could be evaluated. Positive predictive accuracy was 77.8% (7/9) for carcinoids, 100% (5/5) for gastrinomas and 40.0% (2/5) for insulinomas. In three cases, tumor lesions which had been unknown were detected by MP-1727 scintigraphy. The consistent ratio between scintigraphically positive sites and preinjection localizations was 82.0% (41/50 sites) in total. Although adverse drug reactions were observed in two cases, the safety was graded 'not problematic at all' in all of 23 cases. These results show that MP-1727 is a very useful radiopharmaceutical for detection and localization of gastrointestinal hormone producing tumors. |
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| Practice | Clinical medicine |
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| Keywords | 111In-DTPA-D-Phe-octreotide, Gastrointestinal hormone producing tumor, Somatostatin receptor. |
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