影像臨床試驗 Reunion

Post date: 2013/4/28 上午 03:40:57

三年前，本科開始與臨床科合作，協助進行影像臨床試驗，並引進國外藥廠以及 Molecular NeuroImaging, LLC (MNI) 影像 CRO 公司的經驗，建立了臨床試驗SOP，隨後也取得了美國核子醫學會的臨床試驗中心認證。今年 2013-04-25，本科繼續與藥廠的深厚合作，就 TauRx TRx-237-015 藥物實驗，與MNI影像CRO公司再次攜手，利用FDG 腦部PET影像協助臨床評估失智症藥物的治療效果。

一早，NMI的資深影像技師 John Ceccoli，地一部分先就臨床試驗的程序跟大家做說明，並確認臨床研究的成員，進一步就FDG PET影像的SOP，source document，以及一些如何避免query的作為提出說明。

下午，John與本科PET中心的資深技師文正，確認影像品質以及重建的參數!，後續利用 SIMENS PET 進行假體試驗，最後將影像匿名化後，加上研究ID 傳回 MNI core lab 進行 QC。隨著分子影像研究的蓬勃發展，可以遇見類似的交流將會越來越多!

The PET/CT Imaging requirements for the TauRx-237-015 study include the following:

1. 3D PET Imaging of Head/Brain.
2. Injection of 5 mCi (187 MBq) (+/- 10%) of 18F-FDG.
3. Emission imaging at 30 minutes (+/- 5 minutes) following administration of the 18F-FDG with PET Acquisition requiring 6 PET frames for 5 minutes each ( 6 x 5 ), essentially a serial status set of PET images (sometimes referred to as Dynamic Emission scanning). For centers who cameras can only acquire static PET images, one (1) fifteen (15) minute scan will be allowed (a 1 x 15 PET frame).
4. PET Transmission scan using CT or Transmission source - may be acquired prior to or after emission scan depending on your Standard Operating Procedures (recommend performing the transmission scan prior to emission scan).
5. Additionally, obtain blood glucose levels prior to subject being injected with 18F-FDG as well as subjects' weight.