A multicenter clinical study of FDG-PET imaging

ZHANG Zhengwei1 HUA Fengchun1 GUAN Yihui1 XIE Mingxuan2 CUI Bing2 KONG Lingshan2  JIANG Xufeng3 LI Biao3 XUE Fangping1 ZUO Chuantao1 ZHAO Jun1 WANG Hongbing1  1

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A multicenter clinical study of FDG-PET imaging

更新时间：2021-03-12

- A multicenter clinical study of FDG-PET imaging
- NUCLEAR TECHNIQUES Issue 10, (2005)
- 作者机构：
  
  1. 复旦大学附属华山医院PET中心
  2. 第二军医大学长海医院核医学科
  3. 上海第二医科大学附属瑞金医院核医学科
  4. 复旦大学附属华山医院PET中心,上海,200235
  5. ,上海,200025
- 作者简介：
- 基金信息：
- DOI：
  CLC： R817
- Published：01 October 2005
- 稿件说明：
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[1]张政伟,华逢春,管一晖,谢明宣,崔兵,孔令山,江旭峰,李彪,薛方平,左传涛,赵军,王红兵.氟[~(18)F]脱氧葡萄糖的多中心临床研究[J].核技术,2005(10):771-774.

ZHANG Zhengwei1 HUA Fengchun1 GUAN Yihui1 XIE Mingxuan2 CUI Bing2 KONG Lingshan2 JIANG Xufeng3 LI Biao3 XUE Fangping1 ZUO Chuantao1 ZHAO Jun1 WANG Hongbing1 1. A multicenter clinical study of FDG-PET imaging[J]. Nuclear techniques, 2005, (10): 771-774.
[1]张政伟,华逢春,管一晖,谢明宣,崔兵,孔令山,江旭峰,李彪,薛方平,左传涛,赵军,王红兵.氟[~(18)F]脱氧葡萄糖的多中心临床研究[J].核技术,2005(10):771-774. DOI：

ZHANG Zhengwei1 HUA Fengchun1 GUAN Yihui1 XIE Mingxuan2 CUI Bing2 KONG Lingshan2 JIANG Xufeng3 LI Biao3 XUE Fangping1 ZUO Chuantao1 ZHAO Jun1 WANG Hongbing1 1. A multicenter clinical study of FDG-PET imaging[J]. Nuclear techniques, 2005, (10): 771-774. DOI：

摘要

验证上海科兴药业公司提供的氟[18F]脱氧葡萄糖（18F-FDG）注射液的安全性和有效性

并对1个供药中心对多个需要18F-FDG的单位供药的可行性进行探讨。对上海科兴药业公司提供给3家医院的19批显像药物（18F-FDG）进行了性状观察、酸碱度测定、放射化学纯度测定（稳定性最长至合成后9h）、无菌测定

比活度测定、内毒素测定等。药物质量符合要求后静脉注射并显像。结果显示所测试的氟[18F]脱氧葡萄糖（18F-FDG）质量符合标准

放置9h后放射性化学纯度仍符合要求

经过65例患者的18F-FDG临床验证

未发现不良反应

显像效果良好;所完成的65例病人检查中

图像质量均达到甲级片的要求

无1例有不良反应

与多数患者（89.23%）的临床最终诊断相符合

假阳性率为4.61%、假阴性率为6.15%。该显像剂安全有效

可以在具有PET扫描仪或者可以使用18F-FDG的符合线路SPECT扫描仪的多个医疗单位使用。

Abstract

To systematically evaluate the efficacy and safety of radiopharmaceutical 18F-FDG provided by Shanghai Kexing Pharmaceutical Corporation

a multicenter study of FDG-PET imaging was conducted at 3 hospitals in 2003. The sterile aqueous solution of 18F-FDG was injected to patients before five items of determination including specific activity

radiochemical purity

bacterial endotoxins were completed. The quality control of 18F-FDG aqueous solution is found to be efficient and so the agent is safe. Average radiochemical purity is 95.7% and is still no less than 90% after 9 hours. Moreover

FDG-PET imaging is very clear and none of 65 patients showed any bad reaction. Diagnostic conclusions accorded with the last clinical diagnosis for most patients (89.23%)

though there are still a few false positive cases (4.61%) and false negative cases (6.15%). It is feasible that 18F-FDG produced by PET Center equipped with cyclotron and hot cell could be used in the nearby hospitals.

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Department of Nuclear Medicine,The First Affiliated Hospital of Soochow University,Suzhou 215006,China) 2

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