Cryoablation for the Palliation of Painful Bone Metastases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 8
- 主要终点
- Difference in worst pain scores
研究概览
简要总结
This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain associated with metastatic bone tumors.
详细描述
Patients with painful bone metastases who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy will be offered enrollment into the study. Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).
Patients agreeing to participate will read and sign an informed consent form and thus become subjects in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Subjects will be followed for up to 24 weeks (6 months) for palliation of pain, quality of life and analgesic usage. Baseline and follow-up data will be collected for each subject via a web-based electronic data collection tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •18 years of age or older
- •Metastatic bone disease with metastatic disease previously confirmed by prior biopsy; or Metastatic bone disease previously confirmed on imaging [e.g. computed tomography (CT) or magnetic resonance imaging (MRI)] with known (biopsied) primary disease (primary bone cancer is excluded)
- •Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
- •Unremitting pain that resulted in a return visit to the oncologist. The 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite pharmaceutical pain management
- •Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (additional less painful metastatic sites may be present)
- •Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, MRI, or ultrasound (US) imaging
- •Tumors must be suitable for cryoablation
- •Cryoablation should be performed within 14 days of baseline evaluations
- •Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
- •Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
- •ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3
- •Life expectancy ≥ 2 months
- •Platelet count >50,000/mm³ within 6 weeks screening
- •INR (International Normalized Ratio) <1.5 within 6 weeks screening
- •No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
- •If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
- •Clinically suitable for cryoablation therapy
排除标准
- •Leukemia, lymphoma, and myeloma
- •Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
- •Has undergone prior ablation treatment of the index tumor
- •Prior radiation therapy of the index tumor <3 weeks prior to screening
- •Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
- •Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava, bowel, or bladder
- •Surgery at the tumor site or surgery involving the cryoablation-treated tumor (index tumor)
- •Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
- •Patient currently with neutropenia (absolute neutrophil count <1000) within 6 weeks screening
- •Uncontrolled coagulopathy or bleeding disorders
- •Currently pregnant, nursing, or wishing to become pregnant during the study
- •Active, uncontrolled infection
- •Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to study entry
- •Concurrent participation in other experimental studies that could affect the primary endpoint
结局指标
主要结局
Difference in worst pain scores
时间窗: 24 weeks post-cryoablation
The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale.
次要结局
- Subject satisfaction with the amount palliation of pain obtained from cryoablation(24 weeks post-cryoablation)
- Cryoablation retreatments(24 weeks post-cryoablation)
- Additional surgical treatments other than cryoablation(24 weeks post-cryoablation)
- Reduced analgesic usage(24 weeks post-cryoablation)
- Time to maximal palliation of pain after cryoablation(24 weeks post-cryoablation)
- Number of adverse events(30 days post-cryoablation)
- Difference in average pain scores(24 weeks post-cryoablation)
- Time to recurrence of worst pain(24 weks post-cryoablation)