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MR-guidance – a clinical study to evaluate a shuttle- based MR-linac connection to provide MR-guided radiotherapy

机译:MR指导–评估基于航天飞机的MR-直线加速器连接以提供MR指导的放射治疗的临床研究

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Background The purpose of this clinical study is to investigate the clinical feasibility and safety of a shuttle-based MR-linac connection to provide MR-guided radiotherapy. Methods/Design A total of 40 patients with an indication for a neoadjuvant, adjuvant or definitive radiation treatment will be recruited including tumors of the head and neck region, thorax, upper gastrointestinal tract and pelvic region. All study patients will receive standard therapy, i.e. highly conformal radiation techniques like CT-guided intensity-modulated radiotherapy (IMRT) with or without concomitant chemotherapy or other antitumor medication, and additionally daily short MR scans in treatment position with the same immobilisation equipment used for irradiation for position verification and imaging of the anatomical and functional changes during the course of radiotherapy. For daily position control, skin marks and a stereotactic frame will be used for both imaging modalities. Patient transfer between the MR device and the linear accelerator will be performed with a shuttle system which uses an air-bearing patient platform for both procedures. The daily acquired MR and CT data sets will be digitally registrated, correlated with the planning CT and compared with each other regarding translational and rotational errors. Aim of this clinical study is to establish a shuttle-based approach for realising MR-guided radiotherapy for certain clinical situations. Second objectives are to compare MR-guided radiotherapy with the gold standard of CT image guidance for quality assurance of radiotherapy, to establish an appropiate MR protocol therefore, and to assess the possibility of using MR-based image guidance not only for position verification but also for adaptive strategies in radiotherapy. Discussion Compared to CT, MRI might offer the advantage of providing IGRT without delivering an additional radiation dose to the patients and the possibility of optimisation of adaptive therapy strategies due to its superior soft tissue contrast. However, up to now, hybrid MR-linac devices are still under construction and not clinically applicable. For the near future, a shuttle-based approach would be a promising alternative for providing MR-guided radiotherapy, so that the present study was initiated to determine feasibility and safety of such an approach. Besides positioning information, daily MR data under treatment offer the possibility to assess tumor regression and functional parameters, with a potential impact not only on adaptive therapy strategies but also on early assessment of treatment response.
机译:背景技术这项临床研究的目的是研究基于穿梭的MR-直线加速器连接以提供MR引导的放射疗法的临床可行性和安全性。方法/设计将招募总共40例具有新辅助,辅助或确定性放射治疗指征的患者,包括头颈部区域,胸部,上消化道和盆腔区域的肿瘤。所有研究的患者都将接受标准疗法,即高度共形的放射技术,例如CT引导的强度调制放射疗法(IMRT),有或没有伴随化疗或其他抗肿瘤药物,此外,每天在治疗位置使用与之相同的固定设备进行短途MR扫描放射线用于位置验证以及放射治疗过程中的解剖和功能变化的成像。对于日常位置控制,两种成像方式都将使用皮肤标记和立体定位框架。 MR设备和线性加速器之间的患者转移将通过一个穿梭系统执行,该系统在两个过程中都使用带有空气的患者平台。每日获取的MR和CT数据集将进行数字注册,与计划的CT相关,并就平移和旋转误差相互比较。这项临床研究的目的是建立一种基于穿梭的方法,以在某些临床情况下实现MR引导的放射治疗。第二个目标是将MR引导的放射治疗与CT图像引导的黄金标准进行放射治疗质量保证相比较,从而建立适当的MR协议,并评估将基于MR的图像引导不仅用于位置验证的可能性,而且还评估用于放射治疗的适应性策略。讨论与CT相比,MRI可能提供以下优点:无需提供额外的放射剂量即可向患者提供IGRT,并且由于其优越的软组织对比度,可以优化适应性治疗策略。但是,到目前为止,混合型MR-直线加速器装置仍在建设中,尚不临床可应用。在不久的将来,基于航天飞机的方法将成为提供MR引导放射疗法的有前途的替代方法,因此,本研究开始了,以确定这种方法的可行性和安全性。除了定位信息外,每天接受治疗的MR数据还提供了评估肿瘤消退和功能参数的可能性,这不仅对适应性治疗策略有潜在影响,而且对治疗反应的早期评估也有潜在影响。

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