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：（改编自研究者摘要）虽然 在历史上，对于大多数大肿瘤来说，热疗是不可能的， 当足够高的热剂量时， 与放射或药物治疗密切相关。 III期临床试验研究了1小时热处理 在一小时内提供大约10-20%的辐射 分数虽然显示出对小肿瘤的希望，但大多数试验都失败了 为了证明顺序施用的药物之间的充分相互作用， 在大肿瘤中可能的累积热剂量治疗， 使用最好的设备进行最多8次热处理。 本研究的目标是完成 一种大的、灵活的、易于扩展的微波加热器， 将促进新的治疗方案，以最大限度地发挥 通过同时提供良好控制的浅表热量 使用外部光束辐射进行更长时间的治疗，最高可达4 每小时为了实现这一目标，施用器设计参数将 通过系统的参数研究进行理论优化， 使用现有技术的真实施用器和组织负载配置 电磁和热模拟程序。施用器将 设计使其可以舒适地固定在身体表面 一种用于大面积浅表疾病加热的轻质弹性护套， 如乳腺癌胸壁复发。使用优化的 敷贴器设计，非常薄的共形微波阵列敷贴器（3-6 mm，包括水团）将被构造成几种有用的尺寸。 加热模式将通过详细的辐射场进行表征 胸壁组织模型和体内温度测量 在少数动物中的分布测量。最后， 将通过以下方式评价临床中的施用器功能 可行性研究旨在为最终施用者提供反馈 设计修改和评估加热的均匀性，可行性 与外部光束辐射同时加热， 耐受性和毒性的新的热协议，旨在提供 与辐射同时发生的累积热剂量更高。 这项研究应该产生一个经过充分测试的热疗器 设计，准备以相对较低的成本分发给其他 研究中心的补助金结束时，为了启动一个 多机构III期临床试验， 外照射治疗弥漫性浅表性疾病。 预期的长期效益是显著增加 目前对这种毁灭性疾病的治疗效果， 通过提高完全响应率、响应持续时间和质量， 由于相对较高的累积热剂量， 与放射同时进行，以获得最大的协同作用， 方式。