Catheter-Based Ultrasound Hyperthermia System for 3D-Targeted Thermal Therapy

描述（由申请人提供）：用于30靶向热治疗的基于导管的超声热疗系统热疗联合放疗和/或化疗治疗局部晚期或复发盆腔肿瘤（如前列腺、宫颈）已被证明可显著改善临床反应。在许多这类研究中使用的深区域加热技术不能有效地定位规定的温度分布，也不能提供一种方法来验证足够热剂量的输送。我们的总体研究计划是开发高度可控的间质腔内超声加热技术，与HDR近距离放射治疗相结合，显著提高热疗联合标准放化疗对体积较大的IB-IllB（可能为IVA）期宫颈癌患者、复发性前列腺癌患者及其他持续或进展期盆腔肿瘤的治疗效果。凭借我们开发导管超声加热技术的专业知识，包括先前盆腔疾病的临床治疗，我们计划迅速完成间质和腔内热疗应用器和治疗递送系统的高级开发（目标1）。这包括将超声涂抹器和温度传感集成在一个腔内HDR环涂抹器中，用于直接从子宫颈内加热，以及一个用于加热前列腺的经尿道涂抹器。将开发基于图像的治疗计划程序和热模型，并用于确定治疗策略和涂抹器配置，从而显着改善治疗递送和加热一致性（目标2）。因此，在HDR治疗之前或之后，用于放射治疗的相同导管和设备可用于提供合适的热疗并监测肿瘤内温度。将对这种基于导管的超声系统进行临床研究，以提供设计反馈并确定该方法的可行性（目标3）。从这项工作中获得的信息将用于指导未来必要的发展和设计/实施第1 / 2阶段研究，以确定该方法对特定地点的安全性和有效性。同样的技术可以被修改并用于将3D适形热疗应用于HDR近距离治疗的其他部位（例如，头颈部、黑色素瘤、乳房）。

DESCRIPTION (provided by applicant): Catheter-Based Ultrasound Hyperthermia System for 30-Targeted Thermal Therapy Hyperthermia combined with radiotherapy and/or chemotherapy for the treatment of locally advanced or recurrent pelvic tumors (e.g., prostate, cervix) has been shown to dramatically improve clinical response. The deep-regional heating techniques used in many of these studies do not effectively localize a prescribed temperature distribution nor provide a means of verifying delivery of adequate thermal dose. Our overall research plan is to develop highly-controllable interstitial and endocavity ultrasound heating technology to be integrated with HDR brachytherapy as a means to significantly enhance treatment efficacy of combining hyperthermia with standard radiation and chemotherapy for cervical cancer patients with bulky Stage IB-IllB (possibly IVA) disease, recurrent prostate cancer, and other persistent or advanced pelvic tumors. Relying upon our expertise developing catheter-based ultrasound heating technology, including previous clinical treatments of pelvic disease, we plan to expeditiously complete advanced development of interstitial and endocavity hyperthermia applicators and treatment delivery systems (Aim 1). This includes the integration of an ultrasound applicator and temperature sensing within an endocavity HDR ring applicator for heating from directly within the uterine cervix, and a transurethral applicator for heating prostate. Image based treatment planning programs and thermal models will be developed and used to determine treatment strategies and applicator configurations that dramatically improve treatment delivery and heating conformability (Aim 2). Thus, prior to or after the HDR treatment, the same catheters and devices used to deliver radiotherapy can be used to deliver conformable hyperthermia and monitor intratumoral temperatures. A clinical study of this catheter-based ultrasound system will be performed to provide design feedback and determine the feasibility of this approach (Aim 3). The information obtained from this effort will be used to guide future development as necessary and the design/implementation of Phase l/ll studies to determine safety and efficacy of this approach for specific sites. The same technique can be modified and utilized for applying 3D conformal hyperthermia to other sites treated with HDR brachytherapy (e.g., head & neck, melanoma, breast).