The MOMENTUM Study: An International Registry for the Evidence-Based Introduction of MR-Guided Adaptive Therapy.
The MOMENTUM Study: An International Registry for the Evidence-Based Introduction of MR-Guided Adaptive Therapy.
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DOI：
10.3389/fonc.2020.01328
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发表时间：
2020
影响因子：
4.7
通讯作者：
Verkooijen HM
中科院分区：
文献类型：
--
作者：
de Mol van Otterloo SR;Christodouleas JP;Blezer ELA;Akhiat H;Brown K;Choudhury A;Eggert D;Erickson BA;Faivre-Finn C;Fuller CD;Goldwein J;Hafeez S;Hall E;Harrington KJ;van der Heide UA;Huddart RA;Intven MPW;Kirby AM;Lalondrelle S;McCann C;Minsky BD;Mook S;Nowee ME;Oelfke U;Orrling K;Sahgal A;Sarmiento JG;Schultz CJ;Tersteeg RJHA;Tijssen RHN;Tree AC;van Triest B;Hall WA;Verkooijen HM
目的：MR引导放射治疗（MRgRT）允许在实时MR可视化下进行高精度放射治疗。这使得边缘减小和随后的剂量递增成为可能，从而导致更高的肿瘤控制和更少的毒性。Unity MR直线加速器（Elekta AB，斯德哥尔摩，瑞典）集成了直线加速器、1.5 T诊断质量MRI和在线自适应工作流程。建立了一项前瞻性国际登记研究，以促进Unity MR直线加速器在临床实践中的循证实施，系统评价长期结局，并帮助进一步开发基于MR直线加速器的MRgRT技术。方法和结果：2019年2月，在MR-linac联盟内开始了使用MR-linac研究（MOMENTUM）进行放射治疗的多结局评价。MOMENTUM研究是多家医院和行业合作伙伴Elekta之间的国际学术-工业合作伙伴关系。所有接受MR直线加速器治疗的患者都有资格入选MOMENTUM。对于参与者，我们收集临床患者数据（例如，患者、肿瘤和治疗特征）和技术患者数据，其被定义为在治疗期间在MR直线加速器上生成的信息。这些数据在治疗后的两年内以设定的时间间隔被采集、数据化并存储在国际登记处。患者可以选择提供患者报告的结局，并同意在MR直线加速器上进行额外的MRI扫描。本登记研究将作为支持MR直线加速器多中心研究的数据平台。关于数据共享、数据访问和知识产权的规则和规定总结在学术-工业合作协议中。数据访问规则确保了研究者和机构的安全数据处理和研究完整性。对于学术和行业合作伙伴，存在单独的数据访问规则。本研究注册于ClinicalTrials.gov，ID：NCT 04075305（https：//clinicaltrials.gov/ct2/show/NCT 04075305）。结论：多机构MOMENTUM研究旨在收集临床和技术患者数据，以推进技术开发，促进MR直线加速器技术的循证实施，最终目的是改善癌症患者的肿瘤控制、生存和生活质量。
Purpose: 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. Methods and Results: 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). Conclusion: 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.
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影响因子：
3.5
作者：
Lagendijk, Jan J. W.;Raaymakers, Bas W.;van Vulpen, Marco
通讯作者：
van Vulpen, Marco
影响因子：
51.1
作者：
van Loon, Judith;Grutters, Janneke P. C.;Macbeth, Fergus
通讯作者：
Macbeth, Fergus
影响因子：
4.7
作者：
Kerkmeijer, Linda G. W.;Fuller, Clifton D.;van Vulpen, Marco
通讯作者：
van Vulpen, Marco
影响因子：
168.9
作者：
McCulloch, Peter;Altman, Douglas G.;Nicholl, Jon
通讯作者：
Nicholl, Jon
影响因子：
9.8
作者：
Wilkinson MD;Dumontier M;Aalbersberg IJ;Appleton G;Axton M;Baak A;Blomberg N;Boiten JW;da Silva Santos LB;Bourne PE;Bouwman J;Brookes AJ;Clark T;Crosas M;Dillo I;Dumon O;Edmunds S;Evelo CT;Finkers R;Gonzalez-Beltran A;Gray AJ;Groth P;Goble C;Grethe JS;Heringa J;'t Hoen PA;Hooft R;Kuhn T;Kok R;Kok J;Lusher SJ;Martone ME;Mons A;Packer AL;Persson B;Rocca-Serra P;Roos M;van Schaik R;Sansone SA;Schultes E;Sengstag T;Slater T;Strawn G;Swertz MA;Thompson M;van der Lei J;van Mulligen E;Velterop J;Waagmeester A;Wittenburg P;Wolstencroft K;Zhao J;Mons B
通讯作者：
Mons B