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(申请人提供)：这个第一阶段提案的目标是探索超声引导激光微创消融治疗有症状的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疗(LIT)。在这项工作中，我们获得了FDA 510(K)对用于一般软组织消融和凝固的激光和敷贴器系统的批准。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的LITT可能对这种疾病的治疗和临床处理有理想的效果。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敷贴器，它与目前的小活检针兼容，并优化为甲状腺结节的消融。然后我们将在体外和体外组织实验中表征其性能。最后，我们将进行一项试验性临床研究，以确定新疗法在多大程度上提供了预期的临床结果。如果第一阶段的结果表明这样的程序在技术上确实是可行的和有益的，我们将在第二阶段努力扩大系统的能力，并进行旨在扩大和确保该疗法的特定适应症的更大规模的临床试验。公共卫生相关性：如果成功，该项目可能会为相当数量的甲状腺肿块带来另一种治疗选择，比传统的乙醇注射或手术治疗更快、更可控、更容易进行。这反过来将转化为更容易的患者管理，导致对症状性甲状腺结节的更有效的治疗，需要更少的随访和重复治疗。