伽玛刀永久性脑植入物获得 FDA 批准后的首次临床应用。
First clinical implementation of GammaTile permanent brain implants after FDA clearance.
机构信息
Department of Radiation Oncology, University of Minnesota, Minneapolis, MN.
Department of Radiation Oncology, University of Minnesota, Minneapolis, MN.
出版信息
Brachytherapy. 2021 May-Jun;20(3):673-685. doi: 10.1016/j.brachy.2020.12.005. Epub 2021 Jan 22.
PURPOSE
GammaTile cesium-131 (Cs) permanent brain implant has received Food and Drug Administration (FDA) clearance as a promising treatment for certain brain tumors. Our center was the first institution in the United States after FDA clearance to offer the clinical use of GammaTile brachytherapy outside of a clinical trial. The purpose of this work is to aid the medical physicist and radiation oncologist in implementing this collagen carrier tile brachytherapy (CTBT) program in their practice.
METHODS
A total of 23 patients have been treated with GammaTile to date at our center. Treatment planning system (TPS) commissioning was performed by configuring the parameters for the Cs (IsoRay Model CS-1, Rev2) source, and doses were validated with the consensus data from the American Association of Physicists in Medicine TG-43U1S2. Implant procedures, dosimetry, postimplant planning, and target delineations were established based on our clinical experience. Radiation safety aspects were evaluated based on exposure rate measurements of implanted patients, as well as body and ring badge measurements.
RESULTS
An estimated timeframe of the GammaTile clinical responsibilities for the medical physicist, radiation oncologist, and neurosurgeon is presented. TPS doses were validated with published dose to water for Cs. Clinical aspects, including estimation of the number of tiles, treatment planning, dosimetry, and radiation safety considerations, are presented.
CONCLUSION
The implementation of the GammaTile program requires collaboration from multiple specialties, including medical physics, radiation oncology, and neurosurgery. This manuscript provides a roadmap for the implementation of this therapy.
目的
伽玛刀铯-131（Cs）永久性脑植入物已获得美国食品和药物管理局（FDA）的批准，作为治疗某些脑肿瘤的一种有前途的方法。在获得 FDA 批准后，我们中心是美国第一家在临床试验之外提供伽玛刀近距离放射治疗（BT）的机构。本研究的目的是为医学物理学家和放射肿瘤学家在实践中实施这种胶原载体瓦片近距离放射治疗（CTBT）计划提供帮助。
方法
迄今为止，我们中心已对 23 名患者进行了伽玛刀治疗。通过配置 Cs（IsoRay 模型 CS-1，Rev2）源的参数来进行治疗计划系统（TPS）调试，并使用美国医学物理学家协会 TG-43U1S2 的共识数据验证剂量。根据我们的临床经验，制定了植入程序、剂量学、植入后计划和靶区勾画。根据植入患者的照射率测量值以及身体和环形徽章测量值，评估了放射安全方面。
结果
呈现了伽玛刀临床职责的估计时间框架，包括医学物理学家、放射肿瘤学家和神经外科医生。使用 Cs 的已发表水剂量验证了 TPS 剂量。介绍了临床方面，包括瓦片数量估计、治疗计划、剂量学和放射安全注意事项。
结论
伽玛刀计划的实施需要多学科的合作，包括医学物理、放射肿瘤学和神经外科。本文档提供了实施该治疗的路线图。
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