Iodine-125 Peripheral Intravascular Brachytherapy System

Iodine-125 外周血管内近距离治疗系统

• 批准号: 6787597
• 负责人: John J Munro
• 金额: $ 9.48万
• 依托单位: IMPLANT SCIENCES CORPORATION
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-01 至 2005-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6787597
• 关键词: catheterization; drug design /synthesis /production; human therapy evaluation; iodine; iridium; mathematical model; medical implant science; peripheral blood vessel; radiation dosage; radiochemistry; radionuclide implant; radionuclide therapy; radionuclides; restenosis; therapy design /development

DESCRIPTION (provided by applicant): Restenosis of the peripheral vascular arteries is common, morbid and expensive. Initial therapeutic approaches have focused on pharmaceutical agents, mechanical devices (atherectomy or tissue removing), physical devices (stenting) and gene therapy. None of these have been successful. Nor have the recent success surrounding the use of drug-eluting stents in the coronary vascular system yet been translated to the peripheral vascular system. Restenosis has been the Achilles heel of PTA. The current research has shown that intravascular brachytherapy using afterloaded 192-Iridium sources has a beneficial effect of the treatment of restenosis in femoral and popliteal arteries. The drawback to this technique is that patients who have angioplasty performed in the catheterization laboratory must be transported with catheter in situ to the radiation oncology facility where brachytherapy is performed. The aim of this project is to demonstrate that an intravascular brachytherapy system for treatment of peripheral arteries that uses a low-energy source of 125-Iodine will be as safe and effective as the existing system that uses a high-energy source of l92-lridium, and will be suitable to permit the performance of peripheral intravascular brachytherapy within the catheterization laboratory. The accomplishment of this objective will be demonstrated by a) the design and fabrication of a suitable high activity 125-lodine source in the form suitable for delivery for peripheral intravascular treatment, and b) the completion of studies that evaluate the safety and dosimetric efficacy of the prototype source. The principal benefit of this program will be the development of a source and shielding system that will permit the performance of brachytherapy without movement of the patient and its collateral risk, and keep the patient under the supervision of the cardiologist during the procedure. We anticipate that this development will extend the use of peripheral intravascular brachytherapy to a much larger number of hospital centers.

描述（由申请人提供）：外周血管动脉再狭窄是常见的、病态的且昂贵的。最初的治疗方法集中在药剂、机械装置（斑块切除术或组织去除）、物理装置（支架置入术）和基因治疗上。这些都没有成功。最近在冠状血管系统中使用药物洗脱支架所取得的成功也尚未转化为外周血管系统。再狭窄一直是 PTA 的致命弱点。 目前的研究表明，使用后装192-铱源的血管内近距离治疗对于治疗股动脉和腘动脉再狭窄具有有益效果。该技术的缺点是，在导管实验室进行血管成形术的患者必须用导管原位运送到进行近距离放射治疗的放射肿瘤设施。该项目的目的是证明使用 125 碘低能量源治疗外周动脉的血管内近距离治疗系统将与使用 192-铱高能量源的现有系统一样安全有效，并且适合在导管实验室内进行外周血管内近距离治疗。 这一目标的实现将通过 a) 设计和制造适合外周血管内治疗的高活性 125 碘源的设计和制造，以及 b) 评估原型源的安全性和剂量学功效的研究完成来证明。 该计划的主要好处是开发一个源和屏蔽系统，该系统将允许在患者不移动的情况下进行近距离放射治疗及其附带风险，并在手术过程中使患者处于心脏病专家的监督之下。我们预计这一发展将把外周血管内近距离放射治疗的使用扩展到更多的医院中心。