A SonoKnife for Advanced Cancers

用于治疗晚期癌症的声诺刀

• 批准号: 7943978
• 负责人: PETER M. CORRY
• 金额: $ 49.72万
• 依托单位: UNIV OF ARKANSAS FOR MED SCIS
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7943978
• 关键词: Address; Adjuvant; Advanced Malignant Neoplasm; Animal Experimentation; Area; Arts; Biomedical Technology; Categories; Characteristics; Clinical Trials; Data Analyses; Deposition; Development; Devices; Disease; Dose; Ensure; Face; Family suidae; Feedback; Fever; Focused Ultrasound Therapy; Funding; Goals; Head and Neck Squamous Cell Carcinoma; Head and neck structure; Heating; Image; Institution; Intensity-Modulated Radiotherapy; Ionizing radiation; Lesion; Malignant - descriptor; Malignant Neoplasms; Modality; Modeling; Neck; Operative Surgical Procedures; Outcome; Patients; Phase I Clinical Trials; Population; Positive Lymph Node; Principal Investigator; Procedures; Radiation; Radiation therapy; Radiofrequency Interstitial Ablation; Radiosensitization; Recurrence; Relative (related person); Research; Scanning; Skin Temperature; Staging; System; Technology; Temperature; Testing; Therapeutic; Thermal Ablation Therapy; Translations; Ultrasonography; United States Food and Drug Administration; Work; base; clinical practice; clinically relevant; conventional therapy; cytotoxicity; design; high risk; improved; in vivo; innovation; lymph nodes; new technology; open source; outcome forecast; patient population; patient safety; programs; public health relevance; tool; treatment planning; Address; Adjuvant; Advanced Malignant Neoplasm; Animal Experimentation; Area; Arts; Biomedical Technology; Categories; Characteristics; Clinical Trials; Data Analyses; Deposition; Development; Devices; Disease; Dose; Ensure; Face; Family suidae; Feedback; Fever; Focused Ultrasound Therapy; Funding; Goals; Head and Neck Squamous Cell Carcinoma; Head and neck structure; Heating; Image; Institution; Intensity-Modulated Radiotherapy; Ionizing radiation; Lesion; Malignant - descriptor; Malignant Neoplasms; Modality; Modeling; Neck; Operative Surgical Procedures; Outcome; Patients; Phase I Clinical Trials; Population; Positive Lymph Node; Principal Investigator; Procedures; Radiation; Radiation therapy; Radiofrequency Interstitial Ablation; Radiosensitization; Recurrence; Relative (related person); Research; Scanning; Skin Temperature; Staging; System; Technology; Temperature; Testing; Therapeutic; Thermal Ablation Therapy; Translations; Ultrasonography; United States Food and Drug Administration; Work; base; clinical practice; clinically relevant; conventional therapy; cytotoxicity; design; high risk; improved; in vivo; innovation; lymph nodes; new technology; open source; outcome forecast; patient population; patient safety; programs; public health relevance; tool; treatment planning

DESCRIPTION (provided by applicant): This application addresses the broad Challenge Area Enabling Technologies and the primary specific Challenge Topic 06-EB-103 Development of Non-Invasive Therapies and Treatment Procedures (a secondary specific Challenge Topic is 06-EB-102* Development of Biomedical Technologies and Systems). Patients with advanced head and neck squamous cell carcinomas (HNSCC) continue to represent a challenging disease category which faces a poor prognosis and often suffers poor cosmesis from currently conventional treatment practices. Although adjuvant radiochemotherapy has been shown to improve overall survival, innovative therapeutic approaches are clearly needed in view of these persistently poor outcomes. Thermal ablation is a therapeutic modality that has gained acceptance in the treatment of some advanced cancers. We propose incorporation of thermal ablation into the treatment of advanced superficial HNSCC recurrences and/or positive neck lymph nodes. We contend that non-invasive thermal ablation may circumvent or reduce the need for surgery and augment ionizing radiation therapy; thus, possibly providing significant outcome improvements in this high-risk patient population. However, commercially available thermal therapy technologies were not designed for application in the head and neck, and those most accepted, like radiofrequency ablation, are relatively invasive and poorly suited. Therefore, we propose to develop a new technology optimized for thermal ablation of superficial HNSCC and/or positive lymph nodes, namely, the SonoKnife, a scanned, line-focused ultrasound thermal therapy system specifically designed for non-invasive thermal ablation (target temperatures of 50-60¿C). Our working hypothesis is that non- invasive, scanned, line-focused ultrasound can replace/augment surgery in the treatment of advanced superficial HNSCC and/or positive neck nodes. To test this hypothesis we will pursue the following specific aims: (1) Develop a scanned, line-focused, high power ultrasound thermal therapy system (a SonoKnife) to deliver controlled thermal ablation (50-60¿C) to superficial malignant lesions non-invasively. In this project we will develop applicators specifically for superficial head and neck lesions and neck lymph nodes. (2) Implement a practical and clinically useful thermoradiotherapy treatment planning system (TTPS). Three- dimensional, image-based, ultrasound and thermal models will be developed to build the TTPS for the SonoKnife. A computational interface will be developed to communicate with radiotherapy treatment planning systems to integrate thermal and radiation dose data analysis. And (3) perform in vivo studies to evaluate the SonoKnife (SA1) and the TTPS (SA2) in clinically-relevant situations. PUBLIC HEALTH RELEVANCE: Our long-term goal seeks to maximize the therapeutic benefits of thermoradiotherapy by developing specialized heating systems. In particular, we seek to a) improve thermal doses to maximize direct thermal cytotoxicity, and b) deliver ionizing radiation with thermal therapy to maximize heat-induced radiosensitization. We propose the development of a new non-invasive thermal ablation technology to replace or reduce the need for surgery in patients with advanced superficial cancer in the head, neck or neck lymph nodes. We called this new technology the SonoKnife, a scanned, line-focused ultrasound thermal therapy system specifically designed for non-invasive thermal ablation.

描述（由应用程序提供）：本申请地址为广泛的挑战领域促进技术和主要的特定挑战主题06-EB-103的开发非侵入性疗法和治疗程序（次要特定挑战主题是06-EB-102*生物医学技术和系统的开发）。头颈部鳞状细胞癌（HNSCC）的患者继续代表挑战疾病类别，该类别的预后不佳，并且通常会因目前常规的治疗方法而遭受较差的cosmesis。尽管调整放射化学疗法已被证明可以提高整体生存率，但鉴于这些持续差的结果，显然需要创新的治疗方法。热消融是一种治疗方式，在治疗某些晚期癌症方面已得到接受。我们建议将热消融掺入晚期浅表HNSCC回报和/或正颈淋巴结的处理中。我们认为，非侵入性热消融可能会规避或减少手术和增强电离放射治疗的需求。因此，可能在这一高风险患者人群中提供重大结果改善。但是，商业上可用的热疗法技术并不是设计用于头颈部的应用，而最受欢迎的人，例如射频消融，是相对侵入性且适合不适合的。因此，我们建议开发一项针对浅表HNSCC和/或阳性淋巴结的热消融优化的新技术，即Sonoknife是一种专门设计用于非侵入性热消融的扫描，以线路为中心的超声热治疗系统（目标温度为50-60€c）。我们的工作假设是，在治疗晚期表面HNSCC和/或阳性颈部节点时，无创，扫描，以线路为中心的超声可以取代/增强手术。为了检验这一假设，我们将追求以下特定目的：（1）开发扫描的，以线路为中心的高功率超声热治疗系统（SONOKNIFE），以非融合性地提供受控的热消融（50-60€），以使其对表面恶性病变。该项目我们将专门针对浅表头和颈部病变和颈部淋巴结开发涂药器。 （2）实施实用且临床上有用的热治疗计划系统（TTPS）。 Three-dimensional, image-based, ultrasound and thermal models will be developed to build the TTPS for the SonoKnife.将开发一个计算界面，以与放疗治疗计划系统进行通信，以整合热剂量和辐射剂量数据分析。 （3）在临床上相关的情况下进行体内研究以评估Sonoknife（SA1）和TTP（SA2）。 公共卫生相关性：我们的长期目标旨在通过开发专门的加热系统来最大程度地利用热疗法的治疗益处。特别是，我们寻求a）改善热剂量以最大化直接热细胞毒性，b）通过热疗法提供电离辐射，以最大程度地提高热诱导的放射敏化。我们建议开发一种新的非侵入性热消融技术，以替代或减少头部，颈部或颈部淋巴结淋巴结晚期浅表癌患者的手术需求。我们称这项新技术为Sonoknife，这是一种专门针对非侵入性热消融的扫描，以线路为中心的超声热治疗系统。