NCT00026247已完成不适用
A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 8
- 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
- •4.1 Inclusion Criteria
- •4.1.1 Histologically or cytologically documented malignant disease with a bone lesion that has the clinical and/imaging features of metastatic disease.
- •4.1.2 Persistent intractable pain that results in a return visit to the oncologist. The measurable pain must be above a pain scale of five (scale of 0-10). (Pain during the last week described as "the worst" by the patient on a scale of 0 (no pain) to 10 (pain as bad as patient can imagine)).
- •4.1.3 The patient's pain must be from a solitary site of metastatic disease in the bone. Each site must be amenable to RFA utilizing a percutaneous CT-guided approach. (RF electrode can be safely placed under CT guidance without harm to normal structures.) 4.1.4 The maximum size of the bone metastasis (study site) must be no greater than 8 cm.
- •4.1.5 Radiofrequency treatment can be performed within 5 days of baseline evaluations.
- •4.1.6 All patients must understand and sign a study-specific informed consent.
排除标准
- •4.2.1 Tumor mass in contact with hollow viscera. 4.2.2 Uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with FFP and platelets prior to procedure. (Platelets must be ≥ 70,000/ul.) 4.2.3 Aspirin and nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued prior to the procedure for a time period that is appropriate given the drug half life and the drugs known antiplatelet activity (e.g. aspirin for 7 days and ibuprofen 24 hours). Low molecular weight heparin preparations must be discontinued 24 hours prior to procedure.
- •4.2.4 Tumor involves a weight-bearing long-bone of the lower extremity. 4.2.5 Site of tumor surgically stabilized with metallic hardware. 4.2.6 Previous (within 30 days immediately prior to RFA or post RFA) or scheduled concurrent systemic treatment of metastases with external beam radiation or radioisotopes. (Chemotherapy will not be allowed within 14 days prior to and within 14 days post RFA procedure).
- •4.2.7 Patients with primary musculoskeletal malignancies, lymphoma and leukemia will not be RFA treatment candidates.
- •4.2.8 Spinal metastases that do not have an intact cortex between the mass and the spinal canal and exiting nerve roots.
- •4.2.8 Patients with a pacemaker.
研究组 & 干预措施
RFA as pain therapy
Experimental
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
Experimental
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)
- Pain intensity(1 month post-procedure)
- Pain reduction(1 month post-procedure)
- Mood(1 month post-procedure)
- Pain Severity(1 month post-procedure)
研究者
研究点 (8)
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