CONFORMAL APPLICATOR FOR SIMULTANEOUS THERMORADIOTHERAPY

用于同步热放射治疗的适形敷贴器

• 批准号: 2882446
• 负责人: Paul Rath Stauffer
• 金额: $ 11.14万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-05-15 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2882446
• 关键词: bioengineering /biomedical engineering; clinical biomedical equipment; clinical research; combination cancer therapy; evaluation /testing; human subject; human therapy evaluation; microwave radiation; neoplasm /cancer radiation therapy; neoplasm /cancer thermotherapy; phantom model; radiation therapy dosage; relative biological effectiveness; swine

DESCRIPTION: (adapted from the investigator's abstract) Though historically impossible for most large tumors, hyperthermia has been shown effective for small cancers when sufficiently high thermal doses are delivered in close association with radiation or drug therapies. Phase III clinical trials have investigated 1 hour heat treatments delivered within an hour of approximately 10-20% of the radiation fractions. While showing promise for small tumors, most trials failed to demonstrate sufficient interaction between sequentially applied treatments at the cumulative thermal doses possible in large tumors with a maximum of 8 heat treatments using the best available equipment. The objective of the proposed research is to complete the development of a large, flexible, and easily expandable microwave heat applicator that will facilitate new treatment protocols for maximizing interaction of modalities by delivering well-controlled superficial heat simultaneously with external beam radiation for longer duration treatments up to 4 hours each. To accomplish this goal, applicator design parameters will be optimized theoretically with systematic parametric studies of realistic applicator and tissue load configurations using existing electromagnetic and thermal modeling programs. The applicator will be designed so that it can be secured comfortably to the body surface under a lightweight elastic jacket for heating large area superficial disease such as chestwall recurrence of breast carcinoma. Using optimized applicator designs, very thin conformal microwave array applicators (3-6 mm including water bolus) will be constructed in several useful sizes. Heating patterns will be characterized with detailed radiated field measurements in chestwall tissue phantoms and in vivo temperature distribution measurements in a small number of animals. Finally, applicator functionality in the clinic will be evaluated with feasibility studies intended to provide feedback for final applicator design modifications and to assess the uniformity of heating, feasibility of heating simultaneously with external beam radiation, and patient tolerance and toxicity to the new heat protocols intended to deliver higher cumulative thermal doses simultaneously with radiation. This research should produce a fully tested hyperthermia applicator design that is ready to distribute at relatively low cost to other investigational centers by the end of the grant, in order to initiate a multi-institutional Phase III clinical trial of simultaneous heat with external beam radiation for treatment of diffuse superficial disease. The anticipated long term benefits are a significant increase in efficacy of current treatments for this devasting disease, as measured by improved complete response rates, duration of response, and quality of life, due to the addition of relatively high cumulative thermal doses delivered simultaneously with radiation for maximum synergism of modalities.

描述：（根据调查员的摘要进行了改编） 从历史上来说，大多数大肿瘤不可能 当足够高的热剂量时，对小癌症有效 与放射线或药物疗法密切相关。 第三阶段临床试验研究了1小时的热处理 在一个小时内约为辐射的10-20％ 分数。在表现出对小肿瘤的承诺时，大多数试验失败了 在顺序应用之间证明足够的相互作用 在大肿瘤中可能以累积热剂量治疗 使用最佳的设备最多进行8种热处理。 拟议研究的目的是完成 一个大型，灵活且易于扩展的微波热涂抹器 将促进新的治疗方案，以最大程度地提高相互作用 通过同时传递良好控制的表面热量来方式 外束辐射持续时间长达4个 每个小时。为了实现此目标，涂抹器设计参数将 在理论上通过系统的参数研究对 使用现有的现实涂抹器和组织负载配置 电磁和热建模程序。涂抹器将是 设计以使其可以舒适地固定到身体下方的身体表面 轻巧的弹性夹克，用于加热大面积浅层疾病 例如乳腺癌的胸壁复发。使用优化 涂抹器设计，非常薄的保形微波阵列涂抹器（3-6 包括水推注（包括水推注）的MM将以几种有用的尺寸构建。 加热模式将以详细的辐射场来表征 胸壁组织幻像和体内温度的测量 少数动物的分布测量。最后， 将评估诊所中的施用器功能 可行性研究旨在为最终施用者提供反馈 设计修改并评估加热，可行性的均匀性 与外束辐射同时加热，患者 旨在交付的新热量方案的耐受性和毒性 累积的累积热剂量与辐射同时同时进行。 这项研究应产生全面测试的热疗施加器 准备以相对较低的成本分配给其他的设计 调查中心在赠款结束前，以启动 与同时热量的多机构III期临床试验 外束辐射，用于治疗弥漫性浅表疾病。 预期的长期收益是显着增加 如测量 通过提高完整响应率，响应持续时间和质量 生命，由于添加了相对较高的累积热剂量 与辐射同时交付，以最大的协同作用 方式。