FDA批准新的前列腺癌检查显像剂

美国食品药品管理局(FDA)已批准生产胆碱C 11显像剂用于复发性前列腺癌检测。

“当前列腺癌患者血液检查显示复发性癌症但其他影像学检查为阴性时，胆碱C 11注射剂提供了一种重要的影像学方法，有助于确定癌症位置。”FDA药物评价与研究中心的Charles Ganley博士在FDA 声明中指出。

在过去2年中，虽然已有多家影像机构应用胆碱C 11进行PET显像学检查，但均未获得FDA批准生产该显像剂。梅奥医院是首个获得FDA批准生产胆碱C 11注射剂的医学中心，将在明尼苏达州罗彻斯特工厂生产和经销该显像剂。

胆碱C 11的安全性和有效性通过共计98例患者的4项独立研究得到证实。在每项研究中，至少半数PET显像检出的前列腺癌得到了异常部位组织取样的证实。

据FDA声明，PET扫描存在误差和假阳性，这“凸显了对胆碱C 11注射剂PET扫描检出的异常组织进行组织取样验证的必要性”。

除注射部位轻度皮肤反应外，未见胆碱C 11副作用。

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By: NASEEM S. MILLER, Internal Medicine News Digital Network

The Food and Drug Administration has approved the production and use of the imaging agent Choline C 11 for the detection of recurrent prostate cancer.

"Choline C 11 injection provides an important imaging method to help detect the location of prostate cancer in patients whose blood tests suggest recurrent cancer when other imaging tests are negative," noted Dr. Charles Ganley, director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research, in an FDA statement.

Several imaging facilities have been performing PET imaging with Choline C 11 for the past couple of years, but none were approved by the FDA to manufacture the agent. The Mayo Clinic, which manufactures and distributes the agent in its Rochester, Minn., facility, is the first FDA-approved center to produce Choline C 11 injection.

The safety and effectiveness of Choline C 11 were verified after a review of four independent studies of 98 patients. In at least half of the patients in each study, prostate cancer detected by PET imaging was confirmed by tissue sampling of the abnormal areas.

There were also PET scan errors and false positive scans, which "underscore the need for confirmatory tissue sampling of abnormalities detected with Choline C 11 injection PET scans," according to the FDA statement.

No side effects of Choline C 11 were observed, except for mild skin reactions at the injection site.

学科代码：肿瘤学 泌尿外科学 放射学 检验病学　　　关键词：胆碱C 11显像剂 复发性前列腺癌检测
来源： EGMN