Percutaneous US and CT-guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 18
- 主要终点
- Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8
研究概览
简要总结
RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases.
PURPOSE: This clinical trial is studying the side effects and how well percutaneous cryoablation works in treating patients with painful bone metastases.
详细描述
OBJECTIVES:
- To confirm the safety of percutaneous cryoablation in the palliative treatment of patients with painful bone metastases.
- To determine the benefits of cryoablation of painful bone metastases by assessing pain intensity using a standardized Cleeland Brief Pain Inventory (BPI) and quality of life using a standardized SF-8 both before and after treatment.
- To determine the secondary benefits of cryoablation of painful bone metastases by assessing change in analgesic use following therapy.
- To determine the level of anesthesia required for cryoablation with a baseline level of conscious sedation planned for each treatment.
OUTLINE: This is a multicenter study.
Patients undergo percutaneous cryoablation to one or two sites of metastatic disease using the Endocare Cryocare system. Patients with a good initial response to treatment (≥ 2 decrease in pain intensity rating on the Brief Pain Inventory) who develop recurrent pain at the same site or a new painful site ≥ 1 month after initial treatment may undergo one additional cryoablation treatment.
Patients complete pain and quality of life questionnaires periodically.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 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
结局指标
主要结局
Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8
次要结局
- Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months
- Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10
- Percentage of patients who are able to reduce analgesic medications