An early feasibility study of the Nativis Voyager^® device in patients with recurrent glioblastoma: first cohort in US.

Q1 Medicine

CNS Oncology Pub Date : 2019-03-01 Epub Date: 2018-12-14 DOI:10.2217/cns-2018-0013

Charles Cobbs, Edward McClay, J Paul Duic, L Burt Nabors, Donna Morgan Murray, Santosh Kesari

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引用次数: 9

Abstract

Aim: Evaluation of the Nativis Voyager^® device in patients with recurrent glioblastoma (rGBM).

Materials & methods: Voyager is a noninvasive, nonthermal, nonionizing and portable investigational device which delivers ultra-low radio frequency energy (ulRFE^®) that uses a magnetic field to penetrate tissues to alter specific biologic functions within cells. Patients with rGBM were treated with Voyager alone (V) or Voyager in combination with standard of care (V + SoC). Safety and clinical utility were assessed every 2-4 months.

Results: Data from the first 11 patients treated are reported here. Median progression-free survival was 10 weeks in the V arm and 16 weeks in the V + SoC arm. Median overall survival was 16 months in V arm and 11 months in the V + SoC arm. No serious adverse events associated with the device were reported.

Conclusion: These data suggest that the Voyager is safe and feasible for the treatment of rGBM.

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native Voyager®设备用于复发性胶质母细胞瘤患者的早期可行性研究:美国第一队列研究

目的:评价native Voyager®设备在复发性胶质母细胞瘤(rGBM)患者中的应用。材料和方法:Voyager是一种非侵入性、非热、非电离和便携式的研究设备，它提供超低射频能量(ulRFE®)，利用磁场穿透组织，改变细胞内的特定生物功能。rGBM患者单独使用Voyager (V)或Voyager联合标准护理(V + SoC)进行治疗。每2-4个月评估一次安全性和临床效用。结果:本文报道了前11例患者的治疗数据。V组的中位无进展生存期为10周，V + SoC组为16周。V组的中位总生存期为16个月，V + SoC组的中位总生存期为11个月。未报告与该装置相关的严重不良事件。结论:Voyager治疗rGBM是安全可行的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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