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临床试验/NCT03297125
NCT03297125进行中(未招募)不适用

Assessment of Optune Therapy for Patients With Newly Diagnosed Glioblastoma Using Advanced MRI

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
2
主要终点
Overall survival.

研究概览

简要总结

The purpose of this prospective, nonrandomized controlled phase IV study is to compare standard and advanced MRI for their ability to predict response to Optune therapy.

详细描述

Protocol Summary: Optune therapy is a newly approved treatment for patients with glioblastoma. This therapy demonstrated comparable outcomes for patients with recurrent GBM, in comparison to standard therapies, but better quality of life. More recently, in an interim analysis of 315 patients with GBM, adding Tumor Treating Fields (TTFields) to maintenance temozolomide chemotherapy significantly prolonged progression-free and overall survival. It also has demonstrated promise in other cancers such as pancreas, mesothelioma, ovarian and lung. However, in order to optimize the treatment regimen, and potentially predict which patients are most likely to respond, reliable ways of evaluation are necessary. Advanced perfusion and diffusion MRI methods have shown utility with other treatments such as bevacizumab. Preliminary data suggests the same might be true for the evaluation of Optune therapy. The team therefore proposes to determine the utility of these methods to predict response to Optune therapy. A successful result will have wide-ranging implications not only for the optimization of Optune treatment of brain cancer but also other cancers shown to benefit from this novel therapy.

Objective

To compare standard and advanced MRI for their ability to predict response to Optune therapy. The team's approach will be to obtain both standard and advanced MRI in patients with newly diagnosed glioblastoma undergoing adjuvant chemotherapy plus Optune therapy. The ability of standard and advanced MRI to predict response will be assessed. The hypothesis is that perfusion and/or diffusion imaging metrics can be used to predict response to and elucidate mechanisms of action for Optune treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed glioblastoma (GBM), World Health Organization (WHO) grade IV.

排除标准

  • Optune compliance < 75%; they would be excluded from the final analyses.
  • History of craniectomy or significant skull defect (contraindication to Optune).
  • Active implantable medical device (e.g., deep brain stimulator (DBS), spinal cord stimulator, pacemaker, defibrillator, vagus nerve stimulator, programmable shunt).
  • Karnofsky Performance Status (KPS) < 60.

结局指标

主要结局

Overall survival.

时间窗: One year.

The number of subjects alive at one year.

Overall survival.

时间窗: Six months.

The number of subjects alive at six months.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Connelly, MD

Associate Professor

Medical College of Wisconsin

研究点 (2)

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