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临床试验/NCT01515085
NCT01515085终止不适用

MRI-Guided Laser-Induced Thermal Therapy for Cytoreduction of Inoperable Grade III/IV GLiomas Prior to Chemotherapy and Radiation

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
Progression free survival

研究概览

简要总结

Does MR-guided laser interstitial thermal therapy (MRgLITT) prior to chemotherapy and/or radiation give patients a beneficial increase in overall survival? Laser induced thermal therapy (LITT) is a minimally invasive procedure for destroying tissue through generation of heat.

详细描述

Laser induced thermal therapy (LITT) is a procedure for destroying tissue through generation of heat. When used in conjunction with fiberoptic applicators, it offers an excellent means of minimally invasive surgery. As opposed to other thermal techniques like radio-frequency (RF) ablation, or cryo-ablation, LITT may be significantly faster and may exhibit sharper boundary of the thermal ablation zone. More importantly, LITT is highly compatible with MR imaging and when coupled with MR thermal imaging (MRTI) guidance, precise monitoring of the thermal ablation zone in order to avoid eloquent or critical structures is possible.

In this study, we propose to evaluate MR-thermal image guided laser interstitial therapy for the treatment of inoperable brain tumors as upfront therapy prior to initiation of chemotherapy and radiation. MR-thermal imaging (MRTI) will be used to provide information on thermal dose delivered to the target and be used to control laser delivery to prevent damage to critical structures.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Subjects that have/will undergo MRgLITT for inoperable brain tumor.
  • Tumor size < 3cm in transverse diameter for each planned applicator placement.
  • Tumor size < 4 cm in largest dimension.
  • Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.
  • Karnofsky Performance Scale score >
  • ECOG performance status of 2 or better.
  • Biopsy proven histologic diagnosis of malignant glioma.

排除标准

  • Patients with co-existing medical conditions with life expectancy < 1 year.
  • Patients having received pre-ablation chemotherapy and/or radiation to lesion.

结局指标

主要结局

Progression free survival

时间窗: three years

次要结局

  • Overall survival(three years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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