Cone-beam Computed Tomography Guided Percutaneous Cryoablation of Bone Metastases From Endocrine Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- change in the local disease status of the cryoablation treated bone metastases
研究概览
简要总结
This study will evaluate the clinical response and safety of cone beam computed-tomography guided percutaneous cryoablation in bone metastases from thyroid, adrenal and neuroendocrine tumors in 30 patients.
详细描述
Thyroid neoplasms, as well as adrenal and neuroendocrine tumors have the potential to metastasize to bone. About 3% of patients with well-differentiated thyroid carcinomas develop secondary bone lesions, while adrenal and neuroendocrine tumors have 10% and 13% bone metastases rates, respectively. Spinal metastases are associated to a worst prognosis. The progressive systemic disease, the post-operative complications, and the pre-operative neurologic impairment were associated to a worst global survival rate in the thyroid cancer. Additionally, extensive spinal instrumentation of metastatic thyroid carcinoma was associated to greater complication rates. Interventional radiology offers promising techniques for the minimally invasive approach of bone metastases. Image-guided percutaneous radiofrequency ablation and cryoablation techniques have been studied in clinical trials and are considered effective options in pain palliation of patients with bone metastatic disease. These techniques may be associated with conventional treatment, as well as radiation therapy and percutaneous embolization, avoiding major surgical interventions and its complications.
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
- •patients with bone metastases from thyroid, adrenal or neuroendocrine tumor diagnosis, associated to one of the following: pain; risk fracture; risk of compression of spinal cord; hypercalcemia; performance status (ECOG) 0-3; mean life expectancy over one month;
排除标准
- •age < 18 years
- •active anticoagulant therapy or uncorrectable coagulopathy
- •pregnancy or breast feeding
结局指标
主要结局
change in the local disease status of the cryoablation treated bone metastases
时间窗: baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months
absence of neurological impairment and/or pain evaluated by clinical examination and brief pain inventory forms avoiding additional radiation therapy or surgery need
次要结局
- number of participants with treatment-related adverse events according to CTCAE 5.0(baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months)
- evaluation of pain control(baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months)
- evaluation of quality of life(baseline (preprocedure), 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months)
- imaging evaluation (CT or MRI)(baseline (preprocedure); 03 months, 06 months, 12 months, 24 months)
- functional imaging evaluation (PET-CT)(baseline (preprocedure); immediate post-procedure; 06 months)