Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 20
- 主要终点
- Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in participants with pulmonary metastatic disease. This study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 centimeter (cm). Participants will be followed 24 months post their cryoablation procedure.
详细描述
Treatment for pulmonary metastatic disease may include surgery, chemotherapy, radiation therapy, or a combination of treatments. However, several variables may exclude participants from these treatments such as multiple tumors, multiple previous surgeries, pulmonary dysfunction, or co-morbid medical conditions. For these participants, percutaneous cryoablation may be a suitable option.
Ablation of metastatic lung tumors is a rapidly expanding area within interventional oncology. Cryotherapy, radiofrequency, laser, and microwave have all been shown to be effective. Cryotherapy offers a wide range of anatomic and tumor treatment options because of the ability to visualize the ice under imaging guidance and the preservation of collagenous tissue structure. Cryoablation has been extensively performed in the prostate and kidney with favorable outcomes reported in the literature. More recently, cryoablation has been shown to be safe in the treatment of lung tumors with CT guidance.
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
- •Participant must be at least 18 years old.
- •Participant has signed a written informed consent.
- •Participant presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy; or Participant presents with Stage 4 pulmonary metastatic disease previously confirmed on imaging (for example, computerized tomography or CT) with histology proven primary cancer.
- •Participant has up to 6 local pulmonary metastases targetable by cryoablation.
- •Targeted index tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm, measured in the longest cross-sectional dimension.
- •The target index tumor(s) is determined (by CT images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs/ structures and is greater than 0.5 cm from any critical organ/structure (possibly achieved with additional maneuvers such as iatrogenic pneumothorax or hydrodissection).
- •Karnofsky Performance Scale (KPS) score greater than or equal to
- •Platelet count greater than 50,000/millimeters (mm)^3 within 8 weeks prior to initial cryoablation procedure.
- •International Normalized Ratio (INR) less than 1.5 within 8 weeks prior to initial cryoablation procedure.
- •Participant has a life expectancy of greater than 3 months.
排除标准
- •Participant's index tumor(s) is primary lung cancer.
- •Participant has uncontrollable primary or metastatic disease outside of the lung.
- •Participant is unable to lie flat or has respiratory distress at rest.
- •Participant has a coagulopathy or bleeding disorder which is uncontrolled.
- •Absolute Neutrophil Count (ANC) <1000 within 8 weeks prior to initial cryoablation procedure.
- •Participant has evidence of active systemic, pulmonary, or pericardial infection.
- •Participant has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
- •Participant is currently participating in other experimental studies that could affect the primary endpoint (for example, experimental chemotherapy regimen).
结局指标
主要结局
Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12
时间窗: Month 1 (Month 3 if Month 1 Data was missing) and Month 12
Local tumor control defined as the absence of local treatment failure 12 months following study cryoablation based on site-reported data. Local control was achieved if the 3-axis measurement (that is, the greatest trans-axial diameter plus the 2 perpendicular diameters) of a tumor at Month 12 was less than 20% larger than the 3-axis measurement of the tumor at Month 1 following study cryoablation. A separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Month 1 data served as the baseline for this analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at the prior study visit and those with repeat cryoablation procedures prior to Month 12 were counted as failures. Imaging for assessment of tumor measurements was performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast.
次要结局
- Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect(Baseline up to 30 days post-cryoablation)