| Japanese |
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| Title | 甲状腺, 乳腺および肺・縦隔腫瘍の検出における99mTc-MIBIシンチグラフィの臨床的有用性 - 第III相多施設臨床試験報告 - |
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| Subtitle | 技術報告 |
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| Authors | 久保敦司*1, 榎本耕治*2, 日下部きよ子*3, 福光延吉*4, 高見博*5, 大島統男*6, 油野民雄*7, 遠藤啓吾*8, 利波紀久*9, 小西淳二*10, 西村恒彦*11, 楢林勇*12, 増田康治*13 |
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| Authors(kana) | |
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| Organization | *1慶應義塾大学医学部放射線科, *2慶應義塾大学医学部外科, *3東京女子医科大学放射線科, *4東京慈恵会医科大学放射線科, *5帝京大学医学部第一外科, *6帝京大学医学部放射線科, *7旭川医科大学放射線科, *8群馬大学医学部核医学科, *9金沢大学医学部核医学診療科, *10京都大学医学部核医学科, *11大阪大学医学部放射線部, *12大阪医科大学放射線科, *13九州大学医学部放射線科 |
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| Journal | 核医学 |
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| Volume | 35 |
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| Number | 9 |
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| Page | 909-928 |
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| Year/Month | 1998/11 |
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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」甲状腺, 肺・縦隔および乳腺の腫瘍の検出における99mTc-MIBIの臨床的有用性を評価するために136名の患者を対象に第III相臨床試験を実施した. 脱落症例1症例を除く135症例中43症例に異味感, 1症例に嘔気が認められた以外, 自他覚症状の発現はなかった. 本剤に起因すると思われる身体所見および臨床検査値の異常変動も認められなかった. 最終診断が確定しなかった7症例を除く128症例において本剤の有効性を検討した. 悪性腫瘍はその種類, 組織型, 局在部位にかかわらず良好に検出され, 全体で88%の感度であった. 良性腫瘍は6病変中3病変が検出された. 悪性・良性腫瘍123症例中11症例(15部位), および非腫瘍性疾患5症例すべて(6部位)に偽陽性集積が認められた. 有効性については全体の82%において「きわめて有効」あるいは「有効」の評価が得られた. したがって, 本剤は腫瘍の検出において安全で有用な薬剤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-MIBI, Thyroid tumor, Breast tumor, Lung/Mediastinum tumor. |
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| English |
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| Title | Evaluation of Clinical Utility of 99mTc-MIBI Scintigraphy in the Localization of Thyroid, Breast and Lung/Mediastinum Tumors - A Report of Multicenter Phase III Clinical Trials - |
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| Authors | Atsushi KUBO*1, Koji ENOMOTO*2, Kiyoko KUSAKABE*3, Nobuyoshi FUKUMITSU*4, Hiroshi TAKAMI*5, Motoo OSHIMA*6, Tamio ABURANO*7, Keigo ENDO*8, Norihisa TONAMI*9, Junji KONISHI*10, Tsunehiko NISHIMURA*11, Isamu NARABAYASHI*12, Kouji MASUDA*13 |
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| Authors(kana) | |
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| Organization | *1Department of Radiology, School of Medicine, Keio University, *2Department of Surgery, School of Medicine, Keio University, *3Department of Radiology, Tokyo Women's Medical College, *4Department of Radiology, Jikei University School of Medicine, *5First Department of Surgery, Teikyo University School of Medicine, *6Department of Radiology, Teikyo University School of Medicine, *7Department of Radiology, Asahikawa Medical College, *8Division of Nuclear Medicine, Gunma University School of Medicine, *9Division of Nuclear Medicine, School of Medicine, Kanazawa University, *10Department of Nuclear Medicine, Kyoto University Faculty of Medicine, *11Division of Nuclear Medicine, Osaka University Medical School, *12Department of Radiology, Osaka Medical College, *13Department of Radiology, Faculty of Medicine, Kyushu University |
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| Journal | The Japanese Journal of nuclear medicine |
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| Volume | 35 |
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| Number | 9 |
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| Page | 909-928 |
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| Year/Month | 1998/11 |
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| Article | Report |
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| Publisher | THE JAPANESE SOCIETY OF NUCLEAR MEDICINE |
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| Abstract | Phase III clinical study in 136 patients diagnosed or strongly suspected of thyroid, lung/mediastinum or breast cancer was performed to determine clinical utility of 99mTc-MIBI in the localization of tumors, and the results in 135 were evaluated. Except taste peculiar in 43 patients and nausea in one, no adverse events were reported. Seven abnormal changes in vital signs and 27 in clinical laboratories were noted, which were all judged as having no or unlikely relationship to the agent. Out of 177 malignant lesions, 156 (88%) were detected with 99mTc-MIBI regardless of their histology or location. Of 6 benign tumors, 3 were detected. Fifteen sites of false positive in 11 malignant tumor patients and 5 sites in 6 patients with non-tumor disease were observed. Our study indicates that 99mTc-MIBI is a safe and excellent agent for the localization of tumors. Especially, the fact that 99mTc-MIBI detected remote metastatic lesions with high sensitivity is a great advantage over the other conventional imaging modalities. |
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| Practice | Clinical medicine |
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| Keywords | 99mTc-MIBI, Thyroid tumor, Breast tumor, Lung/Mediastinum tumor. |
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