PHSOR07 演讲时间：上午 9:30

IF 1.7 4区医学 Q4 ONCOLOGY

Brachytherapy Pub Date : 2024-10-25 DOI:10.1016/j.brachy.2024.08.081

Inger-Karine Kolkman-Deurloo PhD, Linda Rossi PhD, Andras Zolnay PhD, Miranda Christianen PhD MD, Henrike Westerveld PhD MD, Lorne Luthart Mr, Michele Huge Mrs, Anna Sheremet Mrs, Sebastiaan Breedveld PhD, Wilco Schillemans MSc, Remi Nout PhD MD, Ben Heijmen PhD

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引用次数: 0

摘要

目的根据Embrace-II标准，局部晚期宫颈癌（LACC）的放射治疗包括EBRT和图像引导的自适应腔内/间质BT。众所周知，局部晚期宫颈癌的 BT 治疗是一项复杂而耗时的过程。为了加快这一过程，我们开发了 BiCycle，用于快速自动制定治疗计划。在回顾性和前瞻性验证中，BiCycle 使治疗计划的质量更稳定、更出色，并显著减少了计划时间[Radiother Oncol 148(143)，2020；170(S390)，2022；182(S92)，2023]。欧洲医疗设备法规》（MDR）已于 2021 年 5 月 26 日生效。其主要目的是确保医疗器械的安全性和有效性。本文旨在描述将 BiCycle 作为研究工具转换为符合 MDR 的医疗设备的关键要素。植入物重建、目标和 OAR 划分在商用系统中进行，然后导出到 BiCycle，BiCycle 优化了停留时间，随后将其导入商用 TPS，计算最终剂量分布。在多学科团队定期进行质量保证后，计划将被发送到后装载器并用于治疗。MDR 第 5(5)条允许医疗机构使用内部开发的医疗设备，但必须满足以下条件。医疗机构1) 在其文件中证明市场上的同等器械无法满足目标患者群体的特殊需求； 2) 拟定文件，以便能够了解器械的制造设施和工艺、设计和性能数据，包括预期用途，并足够详细，使主管当局能够确定器械符合一般安全和性能要求；3) 实施并维护适当的质量管理体系 (QMS)，以控制器械的生产和使用； 4) 审查从器械临床使用中获得的经验，并采取一切必要的纠正措施。结果根据 MDR 对 BiCycle 的临床实施和记录持续了 12 个月。1）市场咨询显示，市售的 TPS 均无法满足所有性能要求（即全自动和非劣质）。2) 软件开发由 Redmine 问题跟踪系统 (https://www.redmine.org/) 支持。问题类型以分层方式组织，以便将开发活动与需求联系起来。需求由父问题表示，相应的编程、配置、回归和验收测试问题作为子问题添加。源代码的更改由软件版本系统 Subversion (https://subversion.apache.org/) 跟踪。Redmine 和 Subversion 系统通过在 Subversion 资源库的每次修改中添加的强制性问题 ID 进行链接。这一程序确保了代码与产品需求之间的结构耦合。建立了一个包含 82 个计划的异构数据集，并通过与之前验证的结果进行比较来验证性能。通过风险分析和端到端测试验证了安全要求。端到端测试表明，在已交付的 BiCycle 计划和与 BiCycle 计划具有相同停留位置/时间的手动计划之间，没有测得剂量差异。3) 所有文件都存储在本机构的质量管理系统中，主管当局可随时查阅。4) 自 2023 年 8 月 15 日临床引入以来，我们收集了前瞻性数据，以跟踪临床经验。结论根据 MDR，LACC BT 成功实施了内部开发的用于自动治疗计划的医疗设备软件 BiCycle；2023 年 8 月 15 日进行了首次患者治疗。目前正在收集临床使用经验，并按照 MDR 的要求定期进行审查。

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PHSOR07 Presentation Time: 9:30 AM

Purpose

Radiotherapy for locally advanced cervical cancer (LACC) according to Embrace-II consists of EBRT and image guided adaptive intracavitary/interstitial BT. BT for LACC is known to be a complex and time consuming procedure. To speed up the process, we developed BiCycle for fast and automated treatment planning. In retrospective and prospective validations, BiCycle resulted in more consistent and often superior treatment plan quality and significant decrease in planning time [Radiother Oncol 148(143), 2020; 170(S390), 2022; 182(S92), 2023]. The European Medical Device Regulation (MDR) has been applicable since May 26, 2021. Its main aim is to ensure safety and effectiveness of medical devices. The purpose here is to describe key elements of the conversion of BiCycle as a research tool into an MDR-compliant medical device.

Materials and Methods

BiCycle was implemented as an add-on to our current clinical commercial TPS. Implant reconstruction and target- and OAR delineation are performed in the commercial system and then exported to BiCycle, which optimizes the dwell times, that are subsequently imported in the commercial TPS to calculate the final dose distribution. After regular QA by the multidisciplinary team, the plan is sent to the afterloader and used for treatment. MDR article 5(5) enables health institutions to use in-house developed medical devices, provided that, among others, the following conditions are met. The health institution: 1) Justifies in its documentation that the target patient group's specific needs cannot be met by an equivalent device available on the market; 2) Draws up documentation that makes it possible to have an understanding of the manufacturing facility and -process, design and performance data of the device, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements are met; 3) Implements and maintains an appropriate Quality Management System (QMS) to control manufacturing and use of the device; 4) Reviews experience gained from clinical use of the device and takes all necessary corrective actions.

Results

Clinical implementation and documentation of BiCycle according to MDR lasted ∼12 months. 1) Consultation of the market revealed that none of the commercially available TPS fulfilled all performance requirements (i.e. fully automated and non-inferior). 2) Software development was supported by the Redmine issue tracking system (https://www.redmine.org/). Issue types were organized in a hierarchical way so that development activities were linked to requirements. Requirements were represented by parent issues, and corresponding programming, configuration, regression and acceptance testing issues were added as child issues. Changes to the source code were tracked by the software versioning system Subversion (https://subversion.apache.org/). Redmine and Subversion systems were linked by obligatory issue ID added to each modification to the Subversion repository. This procedure ensures structured coupling between the code and product requirements. A heterogeneous dataset of 82 plans was built and used to verify performance by comparison to previously validated results. Safety requirements were verified using a risk analysis and end-to-end test. The latter revealed no measured dose differences between a delivered BiCycle plan and a manual plan with equal dwell positions/times as the BiCycle plan. 3) All documentation was stored in our institution's QMS and is readily available to the competent authority. 4) Since clinical introduction on August 15, 2023, prospective data are collected to keep track of the clinical experience. In line with MDR, this has already resulted in several requests for system adaptations.

Conclusions

The in-house developed medical device software BiCycle for automated treatment planning was successfully implemented for LACC BT according to the MDR; the 1^st patient treatment was on August 15, 2023. Experience gained from clinical use is now collected and regularly reviewed as required by the MDR.

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来源期刊

Brachytherapy 医学-核医学

CiteScore

3.40

自引率

21.10%

发文量

119

审稿时长

9.1 weeks

期刊介绍： Brachytherapy is an international and multidisciplinary journal that publishes original peer-reviewed articles and selected reviews on the techniques and clinical applications of interstitial and intracavitary radiation in the management of cancers. Laboratory and experimental research relevant to clinical practice is also included. Related disciplines include medical physics, medical oncology, and radiation oncology and radiology. Brachytherapy publishes technical advances, original articles, reviews, and point/counterpoint on controversial issues. Original articles that address any aspect of brachytherapy are invited. Letters to the Editor-in-Chief are encouraged.