2012-11-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/649110摘要：由總計劃所獲致的數據與國外多篇論文所顯示之結果，18F-choline 正子掃描可以提供肝癌病患更有效益的分子造影。尤其18FDG 與18F-choline 兩項正子掃描共同使用之時，更可以將肝癌之診出效果超過90%以上。本研究在配合總計畫之策劃下聯合國內具有代表性之九所教學醫院共同進行一個前瞻性的臨床試驗以求證實18F-choline正子掃描之診斷效益，作為未來申請TFDA查核之參考。本子計畫負責臺灣北區，主要是以台大醫院核子醫學部正子中心生產18FDG與18F-choline供應可及之台大醫院與其他四家醫院為執行本臨床試驗之場所。由於國內罹患肝癌之病患在尋求臨床醫治的過程中會選擇不同的醫療機構，我們選擇這五家醫院是臺灣北區具有代表性的五家。各家醫院負責執行的醫師都必須要撰寫臨床試驗計畫書送各該醫院的臨床試驗委員會(IRB)審核。每家醫院之臨床試驗由各該醫院一位核子醫學科/部醫師與一位胃腸肝膽科醫師共同負責。胃腸肝膽科醫師負責臨床案例之收集以及臨床數據與病情之收集與追蹤，必須符合臨床試驗計畫書之規範；核子醫學科醫師負責18FDG與18F-choline 兩項正子掃描之品管、條件。18FDG 與18F-choline 兩項正子掃描之影像則在收集之後交由總計劃安排之兩名核子醫學專科醫師進行盲目判讀(maskedinterpretation)。吾人期望這三年的研究成果將有助於證實18F-FCH PET/CT 掃描對於肝癌有高可信度的診斷價值，能在肝癌診斷與治療計畫與療效評估上扮演重要角色。<br> Abstract: Based on recent data from abroad and the Main Project, 18F-choline positronemission tomography/computed tomography (PET/CT) has been proved to be veryeffective in the diagnosis of hepatocellular carcinoma (HCC). The diagnostic efficacycan be over 90% with the combination of [18F]Fluorodeoxyglucose (FDG) and18F-choline PET/CT. This prospective study is proceeded with NTUH and 8 otherhospitals in Taiwan under the coordination of the Main Project on doing the clinical trialusing 18F-choline PET/CT in the diagnosis of HCC. The conclusion will be used for theapplication of TFDA approval in the future.The investigators of each site will prepare for the trial protocol and requireddocuments for the application of IRB approval. There will be one nuclear physician anda gastroenterologist responsible for the trial. The trial will follow stringently theprotocol. The quality control of radioactivity measurement and image acquisition,processing will be monitored by same quality control requirement. The final PET/CTscans will be read by two nuclear physicians under masked interpretation.We expected that our research results will prove the high diagnostic values of18F-FCH PET/CT. Eventually, 18F-FCH will play an important role in the diagnosis andprognostic following of HCC in Taiwan.肝細胞癌正子電腦斷層掃描[18F]Fluorocholine[18F]Fluorodeoxyglucose(FDG)Hepatocellular carcinomapositron emission tomography (PET/CT)[18F]Fluorocholine[18F]Fluorodeoxyglucose