Tummers Willemieke S, Warram Jason M, Tipirneni Kiranya E, Fengler John, Jacobs Paula, Shankar Lalitha, Henderson Lori, Ballard Betsy, Pfefer T Joshua, Pogue Brian W, Weichert Jamey P, Bouvet Michael, Sorger Jonathan, Contag Christopher H, Frangioni John V, Tweedle Michael F, Basilion James P, Gambhir Sanjiv S, Rosenthal Eben L
Department of Radiology, Molecular Imaging Program, Stanford University, Stanford, California.
Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama.
Cancer Res. 2017 May 1;77(9):2197-2206. doi: 10.1158/0008-5472.CAN-16-3217. Epub 2017 Apr 20.
Considerable advances in cancer-specific optical imaging have improved the precision of tumor resection. In comparison to traditional imaging modalities, this technology is unique in its ability to provide real-time feedback to the operating surgeon. Given the significant clinical implications of optical imaging, there is an urgent need to standardize surgical navigation tools and contrast agents to facilitate swift regulatory approval. Because fluorescence-enhanced surgery requires a combination of both device and drug, each may be developed in conjunction, or separately, which are important considerations in the approval process. This report is the result of a one-day meeting held on May 4, 2016 with officials from the National Cancer Institute, the FDA, members of the American Society of Image-Guided Surgery, and members of the World Molecular Imaging Society, which discussed consensus methods for FDA-directed human testing and approval of investigational optical imaging devices as well as contrast agents for surgical applications. The goal of this workshop was to discuss FDA approval requirements and the expectations for approval of these novel drugs and devices, packaged separately or in combination, within the context of optical surgical navigation. In addition, the workshop acted to provide clarity to the research community on data collection and trial design. Reported here are the specific discussion items and recommendations from this critical and timely meeting. .
癌症特异性光学成像技术取得了重大进展，提高了肿瘤切除的精准度。与传统成像方式相比，这项技术的独特之处在于能够为手术医生提供实时反馈。鉴于光学成像具有重大临床意义，迫切需要规范手术导航工具和造影剂，以促进快速获得监管批准。由于荧光增强手术需要设备和药物相结合，二者可以联合开发，也可以单独开发，这是审批过程中的重要考量因素。本报告是2016年5月4日与美国国立癌症研究所、美国食品药品监督管理局的官员、美国图像引导外科学会成员以及世界分子成像学会成员举行的为期一天会议的成果，会议讨论了美国食品药品监督管理局指导的人体试验以及研究性光学成像设备和手术用造影剂审批的共识方法。本次研讨会的目标是在光学手术导航的背景下，讨论美国食品药品监督管理局的批准要求以及对这些单独或组合包装的新型药物和设备批准的期望。此外，研讨会还为研究界澄清了数据收集和试验设计方面的问题。以下是此次重要且及时的会议的具体讨论内容和建议。
