Prototype optical device for image guided surgery with panitumumab-IRDye800

 描述（由申请人提供）：来自我们实验室和其他实验室的证据已经证明了荧光标记抗体测量微观疾病以指导手术干预临床前模型的潜力。我们提供了新的数据，证明了荧光标记的抗EGFR抗体在非人灵长类动物和人中的安全性。我们建议与Novadaq合作进行一项临床试验，以开发一种原型术中成像装置，用于首次使用荧光标记帕尼单抗进行人体临床试验。该试验将B设计用于测试药物的安全性，并确定摄像头是否可以在手术室中检测亚临床癌症，以指导头颈部癌症的手术切除。帕尼单抗染料的cGMP生产正在由NCI NExT项目完成。

 DESCRIPTION (provided by applicant): Evidence from our lab and others has demonstrated the potential of fluorescently labeled antibodies to measure microscopic disease to guide surgical intervention preclinical models. We present novel data demonstrating safety of the fluorescently labeled anti-EGFR antibody in non- human primates and humans. We propose a clinical trial in collaboration with Novadaq to develop a prototype intraoperative imaging device for use in a first in human clinical trial with fluorescently labeled panitumumab. The trial will b designed to test safety of the drug and determine if the camera can detect subclinical cancer in the operating room to guide surgical resection of head and neck cancer. The cGMP manufacture of panitumumab-dye is being completed by the NCI NExT program.