A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 16
- 主要终点
- Adverse events
研究概览
简要总结
RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases.
PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing pain in patients who have bone metastases.
详细描述
OBJECTIVES:
- Determine the side effects of radiofrequency ablation in patients with bone metastases.
- Determine the effect of this regimen on pain in these patients.
- Determine the effect of this regimen on mood in these patients.
- Determine the effects of narcotic usage in patients treated with this regimen.
- Determine the relationship between laboratory and imaging features of this treatment and the effects of the treatment in these patients.
OUTLINE: This is a multicenter study.
Patients undergo percutaneous CT-guided radiofrequency ablation directly to the metastatic lesion over approximately 12 minutes.
Pain and mood are assessed at baseline, daily for 14 days after treatment, and at 1 and 3 months after treatment.
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
- 21 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
RFA as pain therapy
Changes in the severity of pain as measured using using the Memorial Pain Assessment Cards (MPAC) before and after RadioFrequency Ablation (RFA) will be statistically analyzed
干预措施: radiofrequency ablation (Procedure)
RFA as pain therapy
Changes in the severity of pain as measured using using the Memorial Pain Assessment Cards (MPAC) before and after RadioFrequency Ablation (RFA) will be statistically analyzed
干预措施: pain therapy (Procedure)
结局指标
主要结局
Adverse events
时间窗: 1 month post procedure
Estimate the adverse event rate due to RFA within 1 month follow-up period.
次要结局
- Pain intensity(3 months post-procedure)
- Pain reduction(3 month post-procedure)
- Mood(3 month post-procedure)
- Pain Severity(3 month post-procedure)