de Mol van Otterloo Sophie R, Christodouleas John P, Blezer Erwin L A, Akhiat Hafid, Brown Kevin, Choudhury Ananya, Eggert Dave, Erickson Beth A, Faivre-Finn Corinne, Fuller Clifton D, Goldwein Joel, Hafeez Shaista, Hall Emma, Harrington Kevin J, van der Heide Uulke A, Huddart Robert A, Intven Martijn P W, Kirby Anna M, Lalondrelle Susan, McCann Claire, Minsky Bruce D, Mook Stella, Nowee Marlies E, Oelfke Uwe, Orrling Kristina, Sahgal Arjun, Sarmiento Jeffrey G, Schultz Christopher J, Tersteeg Robbert J H A, Tijssen Rob H N, Tree Alison C, van Triest Baukelien, Hall William A, Verkooijen Helena M
Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, Netherlands.
Elekta AB, Stockholm, Sweden.
Front Oncol. 2020 Sep 7;10:1328. doi: 10.3389/fonc.2020.01328. eCollection 2020.
MR-guided Radiation Therapy (MRgRT) allows for high-precision radiotherapy under real-time MR visualization. This enables margin reduction and subsequent dose escalation which may lead to higher tumor control and less toxicity. The Unity MR-linac (Elekta AB, Stockholm, Sweden) integrates a linear accelerator with a 1.5T diagnostic quality MRI and an online adaptive workflow. A prospective international registry was established to facilitate the evidence-based implementation of the Unity MR-linac into clinical practice, to systemically evaluate long-term outcomes, and to aid further technical development of MR-linac-based MRgRT. In February 2019, the Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-linac study (MOMENTUM) started within the MR-linac Consortium. The MOMENTUM study is an international academic-industrial partnership between several hospitals and industry partner Elekta. All patients treated on the MR-linac are eligible for inclusion in MOMENTUM. For participants, we collect clinical patient data (e.g., patient, tumor, and treatment characteristics) and technical patient data which is defined as information generated on the MR-linac during treatment. The data are captured, pseudonymized, and stored in an international registry at set time intervals up to two years after treatment. Patients can choose to provide patient-reported outcomes and consent to additional MRI scans acquired on the MR-linac. This registry will serve as a data platform that supports multicenter research investigating the MR-linac. Rules and regulations on data sharing, data access, and intellectual property rights are summarized in an academic-industrial collaboration agreement. Data access rules ensure secure data handling and research integrity for investigators and institutions. Separate data access rules exist for academic and industry partners. This study is registered at ClinicalTrials.gov with ID: NCT04075305 (https://clinicaltrials.gov/ct2/show/NCT04075305). The multi-institutional MOMENTUM study has been set up to collect clinical and technical patient data to advance technical development, and facilitate evidenced-based implementation of MR-linac technology with the ultimate purpose to improve tumor control, survival, and quality of life of patients with cancer.
磁共振引导放射治疗（MRgRT）可在实时磁共振成像的情况下进行高精度放射治疗。这使得能够缩小 margins 并随后提高剂量，从而可能实现更高的肿瘤控制率并降低毒性。Unity MR直线加速器（瑞典斯德哥尔摩的医科达公司）将直线加速器与1.5T诊断级磁共振成像及在线自适应工作流程集成在一起。建立了一个前瞻性国际注册库，以促进将Unity MR直线加速器基于证据地应用于临床实践，系统评估长期结果，并助力基于MR直线加速器的MRgRT的进一步技术发展。2019年2月，使用MR直线加速器的放射治疗多结果评估（MOMENTUM）研究在MR直线加速器联盟内启动。MOMENTUM研究是几家医院与行业合作伙伴医科达之间的国际学术-产业合作项目。所有在MR直线加速器上接受治疗的患者都有资格纳入MOMENTUM研究。对于参与者，我们收集临床患者数据（如患者、肿瘤和治疗特征）以及技术患者数据，技术患者数据定义为治疗期间在MR直线加速器上生成的信息。这些数据在治疗后长达两年的设定时间间隔内被捕获、假名化并存储在国际注册库中。患者可以选择提供患者报告的结果，并同意在MR直线加速器上进行额外的磁共振扫描。该注册库将作为一个数据平台，支持对MR直线加速器进行多中心研究。数据共享、数据访问和知识产权的规则和规定在一份学术-产业合作协议中进行了总结。数据访问规则确保为研究人员和机构进行安全的数据处理并维护研究的完整性。学术和行业合作伙伴有单独的数据访问规则。本研究已在ClinicalTrials.gov注册，注册号为：NCT04075305（https://clinicaltrials.gov/ct2/show/NCT04075305）。多机构的MOMENTUM研究旨在收集临床和技术患者数据，以推进技术发展，并促进基于证据地应用MR直线加速器技术，最终目的是改善癌症患者的肿瘤控制、生存率和生活质量。
