Interstitial Laser Ablation System for Thyroid Nodules

描述（由申请人提供）：本I期提案的目的是探讨超声引导下微创甲状腺结节激光消融的技术可行性。在以前的SBIR支持下，我们开发了一种用于改进激光间质热治疗（LITT）的冷却激光输送系统。在这项工作中，我们获得了用于一般软组织消融和凝固的激光和涂抹器系统的FDA 510(k)批准。在我们与主要消融专家的讨论中，建议在甲状腺结节活检时使用我们的系统进行LITT可能对该疾病的治疗和临床管理有理想的效果。在这项研究中，我们建议通过首先开发一种微型冷却光纤应用器来评估这种方法的技术可行性，该应用器与当前的小型活检针兼容，并优化用于甲状腺结节消融。然后，我们将在体外和离体组织实验中表征其性能。最后，我们将进行一项试点临床研究，以确定新疗法提供所需临床结果的程度。如果第一阶段的结果表明这样的程序在技术上确实可行和有益，我们将在第二阶段工作，以扩大系统的能力，并进行更大的临床试验，旨在扩大和确保治疗的特定适应症。公共卫生相关性：如果成功，该项目可能会为大量甲状腺肿块提供一种替代治疗方案，这种治疗方案比传统的乙醇注射或手术治疗更快、更可控、更容易实施。这反过来又会转化为更容易的患者管理，导致对症状性甲状腺结节更有效的治疗，需要更少的随访和重复治疗。

DESCRIPTION (provided by applicant): The goal of this Phase I proposal is to explore the technical feasibility of minimally invasive ultrasound-guided laser ablation of symptomatic thyroid nodules. Under previous SBIR support, we have developed a cooled laser delivery system for improved laser interstitial thermal therapy (LITT). During this work we obtained FDA 510(k) approval on the laser and applicator system for general soft tissue ablation and coagulation. In our discussions with leading ablation specialists it has been suggested that LITT using our system at the time of thyroid nodule biopsy may have a desirable effect on therapy and clinical management of this disease. In this study we propose to evaluate the technical feasibility of such an approach by first developing a miniature cooled fiber optic applicator which is compatible with current small biopsy needles and optimized for ablation of thyroid nodules. We will then characterize its performance during in vitro and ex vivo tissue experiments. Finally we will perform a pilot clinical study to determine the degree to which the new therapy provides desired clinical results. If Phase I results indicate that such a procedure is indeed technically feasible and beneficial, we will work in Phase II to expand the system capabilities and perform a larger clinical trial aimed at expanding and securing specific indications for the therapy. PUBLIC HEALTH RELEVANCE: If successful, this project could lead to an alternate treatment option for a significant number of thyroid masses which is faster, more controlled, and easier to perform than conventional ethanol injection or surgical therapy. This in turn would translate into easier patient management by resulting in a more effective therapy for symptomatic thyroid nodules requiring fewer follow-ups and repeat therapies.