Interstitial Laser Ablation System for Thyroid Nodules

甲状腺结节间质激光消融系统

• 批准号: 7611223
• 负责人: Ashok Gowda
• 金额: $ 11.94万
• 依托单位: BIOTEX, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-17 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7611223
• 关键词: Ablation; Benign; Biopsy; Body Temperature; Caliber; Chickens; Clinical; Clinical Data; Clinical Management; Clinical Research; Clinical Trials; Coagulation Process; Compatible; Condition; Development; Devices; Disease; Effectiveness; Engineering; Ensure; Ethanol; Evaluation; Excision; Feedback; Fiber; Fiber Optics; Goals; Guidelines; Heating; Hospitals; In Vitro; Injection of therapeutic agent; Invasive; Laser coagulation; Lasers; Lead; Lesion; Low-Level Laser Therapy; Mammary Gland Parenchyma; Measures; Minor; Monitor; Needle biopsy procedure; Nerve; Nerve Tissue; Nodule; Numbers; Operative Surgical Procedures; Patient Selection; Patients; Performance; Phase; Placement; Procedures; Public Health; Research; Research Design; Resected; Rhode Island; Risk; Safety; Sampling; Secure; Series; Site; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Specialist; Standards of Weights and Measures; Structure; System; Techniques; Testing; Thyroid Function Tests; Thyroid Gland; Thyroid Nodule; Time; Tissue Model; Tissues; Translating; Ultrasonography; United States Food and Drug Administration; Work; desire; dosimetry; follow-up; improved; interstitial; research study; size; soft tissue

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.

描述（由申请人提供）：本I期提案的目标是探索微创超声引导激光消融症状性甲状腺结节的技术可行性。在以前的SBIR支持下，我们开发了一种冷却激光传输系统，用于改进激光间质热治疗（LITT）。在这项工作中，我们获得了FDA 510（k）批准的激光和施源器系统用于一般软组织消融和凝固。在我们与领先的消融专家的讨论中，有人建议在甲状腺结节活检时使用我们的系统进行LITT可能对这种疾病的治疗和临床管理产生理想的效果。在这项研究中，我们建议评估这种方法的技术可行性，首先开发一种微型冷却光纤涂药器，它与目前的小型活检针兼容，并优化了甲状腺结节的消融。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种手术确实在技术上是可行的和有益的，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具体适应症。公共卫生关系：如果成功的话，该项目可能会为大量甲状腺肿块提供一种替代治疗方案，与传统的乙醇注射或手术治疗相比，这种方法更快，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，导致一个更有效的治疗症状性甲状腺结节，需要更少的随访和重复治疗。