| Japanese |
|---|
| Title | ヒト免疫グロブリンG-ジエチレントリアミン五酢酸インジウム (111In) (111In-DTPA-IgG) の炎症イメージング剤としての臨床的有用性に関する検討 - 多施設による第II相臨床試験報告 - |
|---|
| Subtitle | 技術報告 |
|---|
| Authors | 久保敦司*1, 小山和行*2, 鈴木謙三*3, 伊藤和夫*4, 遠藤啓吾*5, 宇野公一*6, 間島寧興*7, 後藤元*8, 島田馨*9 |
|---|
| Authors(kana) | |
|---|
| Organization | *1慶應義塾大学病院放射線科, *2東京都立墨東病院診療放射線科, *3東京都立駒込病院放射線診療科, *4北海道大学医学部附属病院核医学講座, *5群馬大学医学部附属病院核医学科, *6千葉大学医学部附属病院放射線科, *7東京都老人医療センター核医学診断科, *8東京都立駒込病院呼吸器内科, *9東京専売病院 |
|---|
| Journal | 核医学 |
|---|
| Volume | 33 |
|---|
| Number | 1 |
|---|
| Page | 85-96 |
|---|
| Year/Month | 1996/1 |
|---|
| Article | 報告 |
|---|
| Publisher | 日本核医学会 |
|---|
| Abstract | 「要旨」炎症イメージング剤として開発された111In-DTPA-IgGの臨床的有用性を評価するために, 局所の感染あるいは炎症が強く疑われた患者59名を対象に第II相臨床試験を実施した. 本剤に起因する自他覚症状の発現, 身体所見や臨床検査値の異常変動は認められず, 本剤の高い安全性が示唆された. 59症例中, 56症例において本剤の臨床的有用性を検討した. 治験担当医師が検討した67部位のうち, 胸腔および筋・骨格系では, 感染あるいは炎症が確認されたすべての病巣に本剤の集積を認めた. また, 偽陽性5例, 偽陰性3例が認められた. 感度および特異性は, それぞれ94.0%および70.6%であり, 91.1%の症例で有効な情報が得られたと評価された. 投与量は80MBq, 撮像時期は投与後1日目あるいは2日目が適当であると考えられた. 以上より, 本剤は炎症イメージング剤として安全で有望な薬剤であると考えられ, 今後さらに第III相臨床試験を行うことは妥当であると判断された. |
|---|
| Practice | 臨床医学：一般 |
|---|
| Keywords | 111In polyclonal human IgG, Clinical study, Inflammation, Infection. |
|---|
| English |
|---|
| Title | Assessment of Clinical Utility of 111In-DTPA-IgG Scintigraphy in the Detection of Inflammation / Infection - A Report of Multicenter Phase II Clinical Trials - |
|---|
| Subtitle | |
|---|
| Authors | Atsushi KUBO*1, Kazuyuki OYAMA*2, Kenzo SUZUKI*3, Kazuo ITOH*4, Keigo ENDO*5, Kimiichi UNO*6, Yasuoki MASHIMA*7, Hajime GOTOH*8, Kaoru SHIMADA*9 |
|---|
| Authors(kana) | |
|---|
| Organization | *1Department of Radiology, School of Medicine, Keio University, *2Department of Radiology, Tokyo Metropolitan Bokuto Hospital, *3Department of Radiology, Tokyo Metropolotan Komagome Hospital, *4Departmnt of Nuclear Medicine, Hokkaido University School of Medicine, *5Department of Nuclear Medicine, School of Medicine, Gunma University, *6Department of Radiology, School of Medicine, Chiba University, *7Department of Nuclear Medicine, Tokyo Metropolitan Geriatric Hospital, *8Department of Pulmonary Diseases, Tokyo Metropolitan Komagome Hospital, *9Tokyo Senbai Hospital |
|---|
| Journal | The Japanese Journal of nuclear medicine |
|---|
| Volume | 33 |
|---|
| Number | 1 |
|---|
| Page | 85-96 |
|---|
| Year/Month | 1996/1 |
|---|
| Article | Report |
|---|
| Publisher | THE JAPANESE SOCIETY OF NUCLEAR MEDICINE |
|---|
| Abstract | [Summary]A Phase II clinical study was performed in patients with strongly suspected focal sites of inflammation/infection to investigate clinical utility of 111In-DTPA-IgG. Neither adverse effects nor abnormal laboratory changes were noted in the all cases. Out of 59 patients, the clinical utility was evaluated in 56 patients with a total of 67 suspicious sites (19 in thorax, 13 in abdomen and pelvis, 30 in musculoskeletal system, and 5 in other regions). True positive results were obtained in 100% of lesions in the thorax (13/13) and the musculoskeletal system (26/26). There were three false negative and five false positive results. Overall sensitivity and specificity was 94.0% and 70.6%, respectively. Most of the true positive scintigram with the best image quality was acquired at Day 1 or Day 2 postinjection. A dose of 80 MBq was considered to be a practical dose for imaging. Our study indicates that 111In-DTPA-IgG is a safe and promising imaging agent for the detection of inflammation/infection, and that it is reasonable to proceed with Phase III studies to further evaluate clinical utility of the agent. |
|---|
| Practice | Clinical medicine |
|---|
| Keywords | 111In polyclonal human IgG, Clinical study, Inflammation, Infection. |
|---|