2009-02-02 FDA 通過F-18 FLT多中心臨床試驗

Post date: 2009/2/4 上午 01:42:09

The FDA has approved an SNM-sponsored multicenter investigational new drug application for F-18-labeled 3'-deoxy-3'-fluorothymidine -- a PET imaging agent used in measuring tumor growth and response to therapy. The multicenter IND allows multiple generators of the FLT agent to be evaluated under a single application, resulting in cost and time savings.

為了加速核醫診斷新藥的開發速度,日前FDA通過由美國核醫學會贊助的F-18 FLT多中心臨床試驗案,以往,類似的研究多由各醫院單一IND主導,各醫院的放射製藥結果不一,也影像了藥廠投入新藥研發的意願。

該藥物目前在國內有台大核子醫學科正在進行類似的臨床試驗。F-18 FLT-PET可以針對腫瘤的細胞增生做定量測量,是一個潛在的腫瘤增生標記!

原始來源 | Dignosticimaging.com

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