NAPTA: Optimizing clinical trial design & delivery of particle therapy for cancer

NAPTA：优化临床试验设计

基本信息

批准号：
9012031
负责人：
ELEANOR A BLAKELY
金额：
$ 49.6万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-02-10 至 2018-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9012031
关键词：
Acute Address Adopted Adult American Biological Brain Cancer Patient Carbon Carbon ion Charge Clinical Clinical Research Clinical Trials Design Collaborations Country Development Documentation Dose Educational workshop Effectiveness Esophagus Europe Funding Future Germany Goals Head and neck structure Health Heavy Ions High-LET Radiation Hypoxia Imaging technology Industry Institution International Investigation Ions Italy Japan Knowledge Laboratories Late Effects Light Linear Energy Transfer Location Low Linear Energy Transfer Radiotherapy Lung Neoplasms Malignant Neoplasms Medical Neon Neutrons Normal tissue morphology Operative Surgical Procedures Outcome Oxygen Pancreas Patients Phase Photons Physics Production Protocols documentation Proton Radiation Protons Radiation Radiation Oncology Radiation therapy Radiobiology Research Research Activity Research Infrastructure Research Project Grants Resistance Rest Risk Second Primary Cancers Study models System Technical Expertise Technology Therapeutic Studies Toxic effect Uncertainty United States Vision Work base cancer risk cancer therapy chemotherapy clinical investigation cost cost effective design follow-up frontier improved improved outcome interest neoplastic cell organizational structure particle particle beam particle therapy public health relevance radioresistant randomized trial research and development response treatment planning tumor

项目摘要

DESCRIPTION (provided by applicant): More than half of all cancer patients receive definitive radiotherapy (RT), usually with x-rays. Particle beam radiation therapy (PBRT) with low linear energy transfer (LET) protons is increasingly being used based on the assumption they can reduce complications and improve local control. High-LET PBRT, e.g., with carbon ions, may provide additional physical dose distribution advantages over low-LET RT. In addition, carbon and neon may yield an increased level of effectiveness against radioresistant and hypoxic (poorly oxygenated) tumor cells, which represent the most RT- and chemotherapy-resistant aggressive tumor cells. Adult patients with advanced tumors of the lung, head and neck, brain, esophagus, and pancreas may especially benefit from the advantages of high-LET ions, but the studies conducted to date have not been definitive. To justify the development of an expensive PBRT facility with high-LET ions, definitive studies (i.e., randomized trials) are needed to prove that high-LET ion beam RT results in improved outcomes compared to treatment with low- LET protons or advanced x-ray based therapy such as intensity modulated radiation (IMRT) or stereotactic body radiotherapy (SBRT). The North American Particle Therapy Alliance (NAPTA) brings together experts in radiation oncology, medical and accelerator physics, magnet design, and radiobiology with international consultants from the existing ion beam facilities in Germany, Italy, and Japan. The main objective of NAPTA is to build a future for ion therapy in the U.S. by integrating and developing the required clinical, biological and technical expertise. In this initil two-year funding period, we will: 1) form a network of teams with a common vision for R&D and clinical studies involving PBRT; 2) enhance clinical PBRT research by developing the infrastructure for treating all patients within common protocols shared by all partner institutions 3) facilitate the development of new, low-cost, compact/efficient designs for ion accelerators, ion gantries, treatment planning systems, and imaging technology; and 4) facilitate the development of "new knowledge" in radiobiology related to PBRT, by integration of currently ongoing projects and startup of collaborations with access to existing facilities with protons and ions.

描述（由申请人提供）：超过一半的癌症患者接受根治性放射治疗（RT），通常采用低线性能量转移（LET）质子的粒子束放射治疗（PBRT），基于以下原因越来越多地使用。假设它们可以减少并发症并改善局部控制，例如使用碳离子，可能会比低 LET RT 提供额外的物理剂量分布优势。此外，碳和氖可能会产生更高的水平。对放射抗性和缺氧（氧合不良）肿瘤细胞的有效性尤其适用于患有肺、头颈、脑、食道和胰腺晚期肿瘤的成年患者。高 LET 离子的优点，但迄今为止进行的研究尚未确定，为了证明开发具有高 LET 离子的昂贵 PBRT 设施的合理性，需要进行明确的研究（即随机试验）来证明这一点。与低 LET 质子治疗或先进 X 射线治疗（例如调强放射治疗 (IMRT) 或立体定向全身放射治疗 (SBRT)）相比，高 LET 离子束放疗可改善治疗效果。 NAPTA 汇集了放射肿瘤学、医学和加速器物理、磁体设计和放射生物学领域的专家以及来自德国、意大利和日本现有离子束设施的国际顾问。 NAPTA 的主要目标是构建未来。通过整合和开发所需的临床、生物学和技术专业知识，我们将在美国开展离子治疗。在最初的两年资助期内，我们将： 1) 组建一个具有共同愿景的团队网络，参与 PBRT 的研发和临床研究； 2) 通过开发用于在所有合作机构共享的通用协议下治疗所有患者的基础设施来加强临床 PBRT 研究 3) 促进离子加速器、离子加速器、离子加速器、离子加速器等新型、低成本、紧凑/高效设计的开发机架、治疗计划系统和成像技术；4) 通过整合当前正在进行的项目并启动与现有质子和离子设施的合作，促进与 PBRT 相关的放射生物学“新知识”的发展。

项目成果

期刊论文数量（15）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

The effect of beam purity and scanner complexity on proton CT accuracy.

光束纯度和扫描仪复杂性对质子 CT 精度的影响。

DOI：
发表时间：
2017-01
期刊：
影响因子：
3.8
作者：
Piersimoni, P;Ramos;Geoghegan, T;Bashkirov, V A;Schulte, R W;Faddegon, B A
通讯作者：
Faddegon, B A

Clinical trials involving carbon-ion radiation therapy and the path forward.

涉及碳离子放射治疗的临床试验和前进的道路。

DOI：
发表时间：
2018
期刊：
影响因子：
6.2
作者：
Lazar, Ann A;Schulte, Reinhard;Faddegon, Bruce;Blakely, Eleanor A;Roach 3rd, Mack
通讯作者：
Roach 3rd, Mack

Stopping power accuracy and achievable spatial resolution of helium ion imaging using a prototype particle CT detector system.

使用原型粒子 CT 探测器系统进行氦离子成像的阻止功率精度和可实现的空间分辨率。

DOI：
发表时间：
2017-09
期刊：
影响因子：
0
作者：
Volz, Lennart;Collins;Piersimoni, Pierluigi;Johnson, Robert P;Bashkirov, Vladimir;Schulte, Reinhard;Seco, Joao
通讯作者：
Seco, Joao

Helium CT: Monte Carlo simulation results for an ideal source and detector with comparison to proton CT.

氦 CT：理想源和探测器的蒙特卡罗模拟结果与质子 CT 的比较。

DOI：
发表时间：
2018-07
期刊：
影响因子：
3.8
作者：
Piersimoni, Pierluigi;Faddegon, Bruce A;Méndez, José Ramos;Schulte, Reinhard W;Volz, Lennart;Seco, Joao
通讯作者：
Seco, Joao

Applications of nanodosimetry in particle therapy planning and beyond.

纳米剂量测定法在粒子治疗规划及其他领域的应用。