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

NAPTA：优化临床试验设计

• 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
• 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

 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明确的放射治疗（RT），通常使用X射线。基于可以减少并发症和改善局部控制的假设，越来越多地使用具有低线性能量转移（LET）质子的粒子束放射治疗（PBRT）。高LET PBRT，例如，此外，碳和氖可以产生针对放射抗性和缺氧（氧合不良）肿瘤细胞的增加的有效性水平，所述肿瘤细胞代表最耐RT和化疗的侵袭性肿瘤细胞。患有晚期肺、头颈部、脑、食管和胰腺肿瘤的成人患者可能特别受益于高LET离子的优势，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，确定性研究（即，随机试验）来证明高LET离子束RT与使用低LET质子或基于先进X射线的治疗（例如调强放射（IMRT）或立体定向体放射治疗（SBRT））的治疗相比导致改善的结果。北美粒子治疗联盟（NAPTA）汇集了放射肿瘤学、医学和加速器物理学、磁体设计和放射生物学方面的专家，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的主要目标是通过整合和开发所需的临床，生物和技术专业知识，在美国建立离子治疗的未来。在这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，以进行PBRT的研发和临床研究; 2）通过开发所有合作机构共享的通用协议治疗所有患者的基础设施，加强PBRT的临床研究; 3）促进开发新的，低成本，紧凑/高效的离子加速器设计，离子加速器设计，离子加速 机架、治疗计划系统和成像技术;以及4）通过整合当前正在进行的项目和启动与使用质子和离子的现有设施的合作，促进与PBRT相关的放射生物学中的“新知识”的发展。

项目成果

The impact of secondary fragments on the image quality of helium ion imaging.

• DOI: 10.1088/1361-6560/aadf25
• 发表时间: 2018-10-02
• 期刊: Physics in medicine and biology
• 影响因子: 3.5
• 作者: Volz L;Piersimoni P;Bashkirov VA;Brons S;Collins-Fekete CA;Johnson RP;Schulte RW;Seco J
• 通讯作者: Seco J

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

• DOI: 10.1002/mp.12942
• 发表时间: 2018-07
• 期刊: Medical physics
• 影响因子: 3.8
• 作者: Piersimoni P;Faddegon BA;Méndez JR;Schulte RW;Volz L;Seco J
• 通讯作者: Seco J

Use of the NASA Space Radiation Laboratory at Brookhaven National Laboratory to Conduct Charged Particle Radiobiology Studies Relevant to Ion Therapy.

• DOI: 10.1667/rr14412.1
• 发表时间: 2016-06
• 期刊: Radiation research
• 影响因子: 3.4
• 作者: Held KD;Blakely EA;Story MD;Lowenstein DI
• 通讯作者: Lowenstein DI

New Clinical and Research Programs in Particle Beam Radiation Therapy: The University of California San Francisco Perspective.

粒子束放射治疗的新临床和研究项目：加州大学旧金山分校的观点。

• DOI: 10.14338/ijpt-15-00025.1
• 发表时间: 2016
• 期刊: International journal of particle therapy
• 影响因子: 1.7
• 作者: Roach3rd,Mack;Schulte,Reinhard;Mishra,Kavita;Faddegon,Bruce;Barani,Igor;Lazar,Ann;Blakely,EleanorA
• 通讯作者: Blakely,EleanorA

Particle-Tracking Proton Computed Tomography-Data Acquisition, Preprocessing, and Preconditioning.

• DOI: 10.1109/access.2021.3057760
• 发表时间: 2021
• 期刊: IEEE access : practical innovations, open solutions
• 作者: Schultze B;Karbasi P;Sarosiek C;Coutrakon G;Ordoñez CE;Karonis NT;Duffin KL;Bashkirov VA;Johnson RP;Schubert KE;Schulte RW
• 通讯作者: Schulte RW