TAS::75 0849::TAS TARGETED PHOTOTHERMAL ABLATION OF MELANOMA

我们建议开发一种商业产品和程序，用于黑色素瘤的光热消融，包括转移瘤，使用靶向，近红外吸收纳米粒子，使用经皮激光能量输送照射。该方法已在小鼠模型中成功证明，该建议将可行性证明扩展到自发性黑色素瘤猪模型中。如果成功，II期提案将进行必要的临床前、体外和实验室研究，以向FDA提交研究器械豁免申请。黑色素瘤具有侵袭和转移能力强的特点。转运转移、淋巴结转移和脑转移是本病患者的严重问题。尽管转运转移和脑转移采用了多种治疗方法，但治疗失败率仍然很高。迫切需要创新的微创技术，能够成功地靶向和治疗转移性病变，同时对周围正常组织施加最小的影响。

We propose to develop a commercial product and procedure for the photothermal ablation of melanoma, including metastases, using targeted, near-infrared absorbing nanoparticles illuminated using a percutaneous laser energy delivery. This approach has been successfully demonstrated in a mouse model, and this proposal will extend the proof of feasibility into a spontaneous melanoma pig model. If successful , the Phase II proposal would conduct the necessary preclinical, in vitro and laboratory studies for an Investigational Device Exemption filing with FDA. Melanoma is characterized by a high capacity for invasion and metastasis. In-transit metastases, lymph node metastases, and brain metastases are serious problems in patients with this disease. Despite the application of various treatment approaches for in-transit metastases and brain metastases, the rate of treatment failure remains high. There is a critical need for innovative, minimally invasive techniques that can successfully target and treat metastatic lesions,while exerting minimal effects on surrounding normal tissue.