Feasibility of a New Thermo-brachytherapy Seed for Concurrent Brachytherapy and H

新型热近距离放射治疗种子同时进行近距离放射治疗和 H 的可行性

• 批准号: 8058357
• 负责人: E ISHMAEL PARSAI
• 金额: $ 11.6万
• 依托单位: BEST MEDICAL INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-20 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8058357
• 关键词: Achievement; Adjuvant; Adverse effects; Alloys; American Cancer Society; Animals; Brachytherapy; Brachytherapy Seeds; Cancer Control; Clinical; Clinical Data; Clinical Engineering; Clinical Trials; Comparative Study; Computer Simulation; Development; Dose; Early treatment; Electromagnetic Fields; Elements; Ensure; Evaluation; External Beam Radiation Therapy; Failure; Feasibility Studies; Fever; Gland; Goals; Heating; Hour; Implant; Implantation procedure; Informal Social Control; Literature; Localized Malignant Neoplasm; Logistics; Malignant neoplasm of prostate; Mediating; Modality; Modeling; Modification; Patients; Penetration; Phase; Probability; Procedures; Property; Prostate; Protocols documentation; Publishing; Radiation; Radiation therapy; Radiation-Sensitizing Agents; Radioactive; Recurrence; Regional Cancer; Relative (related person); Reporting; Salvage Therapy; Seed Implantation; Seeds; Series; Source; Staging; Structure; Systemic Therapy; Techniques; Technology; Temperature; Testing; Thermogenesis; Thermometry; Time; Tissues; Translations; Treatment Protocols; Tungsten; Ultrasonography; Universities; base; cancer therapy; commercialization; design; hormone therapy; hyperthermia treatment; implantation; innovation; innovative technologies; internal radiation; interstitial; magnetic field; men; microwave electromagnetic radiation; news; pre-clinical; prototype; research clinical testing; seal; simulation; statistics; thermal seeds; time interval; tumor

DESCRIPTION (provided by applicant): Adjuvant administration of radiation therapy with hyperthermia in treatment of cancer has been studied extensively in the past three decades (Deger et al., 2004), but simultaneous delivery of these modalities using the same source has not been documented. Here we propose feasibility study, development and clinical implementation of a new Thermo-brachytherapy seed that combines a sealed radioactive source with a ferromagnetic core serving as a self-regulating hyperthermia source when placed in an alternating electromagnetic field. The proposed new seed is based on the conventional 125I seed commonly used for prostate implant with addition of a ferromagnetic core in place of the tungsten marker to be implemented as a heat source. In addition to being used as a source for both radiation and heat at the onset of cancer therapy, these implanted seeds could be used for thermal re-treatment of the tumor in case of recurrence, possibly as a sensitizer to systemic therapies without another invasive procedure. The combination of a magnetic field and a self-regulating seed will preclude the need for invasive thermometry and provides relative ease of the heat delivery especially to deep-seated tumors. With this approach heat self-regulation is achieved by employing the Curie temperature of a ferromagnetic metallic alloy, distinct to its composition, leading to drastic decrease in heat production after reaching the targeted treatment temperature range. This innovation is in contrast to clinically available technology where hyperthermia is delivered by microwave and ultrasound applicators resulting in limited penetration and the inherent need for invasive thermometry. The goals for this project include: complete dosimetric characterization and evaluation of this newly developed dual function seed using Monte Carlo simulation, and characterization and evaluation of its thermal properties using the finite element modeling. Through our partnership with the University of Toledo we aim at development and manufacturing of a prototype, and studying its efficacy in concurrent delivery of radiation and heat. The interdisciplinary team of experts assembled for this project covers all anticipated aspects of the proposed project, including scientific, engineering, and clinical issues, thus ensuring the successful achievement of the specific aims set forth. Successful completion of the Phase I will propel the project into the Phase II stage of development of a fully functional seed prototype. Successive translation of the prototype into a highly effective clinical procedure of concurrent administration of brachytherapy and hyperthermia for prostate cancer treatments will prepare Thermo- brachytherapy seed for immediate commercialization. PUBLIC HEALTH RELEVANCE: Of the nearly 187000 men estimated to get the news for prostate cancer this year in US alone, about 1 in 6 will die from it based on statistics published by the American Cancer Society. The technique proposed in this project has the potential to reduce this ratio and increase the probability of tumor control without a significant change in treatment regimen currently offered. Through an innovative technology and modification of an existing radioactive implant, an adjuvant fractionated hyperthermia treatment can be integrated into radiation delivery procedure, and can be used for salvage therapy in case of a failure by re-heating the gland via the already implanted seeds.

DESCRIPTION (provided by applicant): Adjuvant administration of radiation therapy with hyperthermia in treatment of cancer has been studied extensively in the past three decades (Deger et al., 2004), but simultaneous delivery of these modalities using the same source has not been documented.在这里，我们提出了一种新型热近距离放射治疗种子的可行性研究、开发和临床实施，该种子将密封放射源与铁磁芯相结合，当放置在交变电磁场中时，可作为自我调节热疗源。所提出的新种子基于常用于前列腺植入的传统 125I 种子，并添加铁磁芯代替钨标记以用作热源。 In addition to being used as a source for both radiation and heat at the onset of cancer therapy, these implanted seeds could be used for thermal re-treatment of the tumor in case of recurrence, possibly as a sensitizer to systemic therapies without another invasive procedure. The combination of a magnetic field and a self-regulating seed will preclude the need for invasive thermometry and provides relative ease of the heat delivery especially to deep-seated tumors.通过这种方法，通过采用与其成分不同的铁磁金属合金的居里温度来实现热量自调节，从而在达到目标处理温度范围后导致热量产生急剧减少。 This innovation is in contrast to clinically available technology where hyperthermia is delivered by microwave and ultrasound applicators resulting in limited penetration and the inherent need for invasive thermometry. The goals for this project include: complete dosimetric characterization and evaluation of this newly developed dual function seed using Monte Carlo simulation, and characterization and evaluation of its thermal properties using the finite element modeling.通过与托莱多大学的合作，我们的目标是开发和制造原型，并研究其同时传递辐射和热量的功效。该项目组建的跨学科专家团队涵盖了拟议项目的所有预期方面，包括科学、工程和临床问题，从而确保了所提出的具体目标的成功实现。第一阶段的成功完成将推动该项目进入全功能种子原型开发的第二阶段。将原型成功转化为同时进行近距离放射治疗和热疗治疗前列腺癌的高效临床程序，将为近距离放射治疗的立即商业化做好准备。 公共健康相关性：根据美国癌症协会公布的统计数据，今年仅在美国就有近 187000 名男性得知前列腺癌的消息，其中约六分之一的人将死于前列腺癌。 The technique proposed in this project has the potential to reduce this ratio and increase the probability of tumor control without a significant change in treatment regimen currently offered. Through an innovative technology and modification of an existing radioactive implant, an adjuvant fractionated hyperthermia treatment can be integrated into radiation delivery procedure, and can be used for salvage therapy in case of a failure by re-heating the gland via the already implanted seeds.