Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Pain response
研究概览
简要总结
The aim of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device for the palliation of pain in patients with bone metastases.
Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) uses ultrasound to palliate pain caused by bone metastases. The main palliative mechanism of the method is due to local bone denervation, caused by the heat denaturation of the periosteum layer in the treated area. The importance of this therapy is that it offers a non-invasive, focal therapy, avoiding side-effects to surrounding normal tissue that occur with radiation therapy or the need for needle insertion as with radio-frequency(RF)ablation.
The study hypothesis is that MR-HIFU will be effective in treating the pain associated with bone metastases
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •radiologic evidence of bone metastases from any solid tumour
- •diagnosis of dominant painful bone metastasis
- •target lesion less than 8cm
排除标准
- •primary bone tumours rather than metastases
- •Inability to tolerate stationary position during treatment
- •pregnancy
- •MRI incompatible metal implants
研究组 & 干预措施
MR-HIFU of painful bone metastases
干预措施: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) (Device)
结局指标
主要结局
Pain response
时间窗: 30 days post-treatment
次要结局
未报告次要终点
研究者
NdeSouza
Professor of Translational Imaging
Institute of Cancer Research, United Kingdom