MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Efficacy of microwave ablation.
研究概览
简要总结
Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?
详细描述
Surgical resection is the gold standard treatment for localized non-small cell lung cancer (NSCLC). However, surgery is invasive and not all patients are surgical candidates, thus providing an opportunity for percutaneous microwave ablation, for both primary and metastatic disease. Patients that are deemed inoperable are typically treated with other targeted therapies such as radiofrequency ablation (RFA), cryoablation and stereotactic body radiation therapy (SBRT), or systemic therapies. Percutaneous microwave ablation (MWA) is an alternative option for targeted treatment of cancer. Microwave tumor ablation is a procedure that uses heat made by an electric current to destroy a tumor (ablation). With imaging equipment, such as ultrasound or CT (computed tomography), and a small incision made in the skin, the tumor is located and treated with radiofrequency energy. The cells that are killed by the microwave ablation are typically not removed but are eventually replaced by fibrosis and scar tissue. Patients will be followed for 1 year by contrast enhanced chest CT, chest PET/CT and chest PET/MRI to evaluate lesion outcomes.
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
- •Subject must be at least 18 years old.
- •Subject is able to understand the study procedures and provide informed consent.
- •Subject is willing and able to complete the entire study as specified in the protocol, including the follow-up visits.
- •Subject has lung lesion that is biopsy-proven cancer (of any type) or suspicious, with confirmation at the time of the procedure.
- •Lung lesion(s) are reachable/treatable per clinician opinion.
- •Subject can have other location of disease if it is controlled, or there are plans for control.
- •Subject has 1 or more lung nodules (not more than 10), that have a mean diameter <3 cm on axial CT scan.
- •Life expectancy ≥6 months
排除标准
- •Subject is pregnant or breast feeding.
- •Subject has a significant clinical disease or condition, e.g. cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematological, psychiatric or neurologic that would preclude enrollment, as determined by the primary investigator.
- •Subject has another location of disease that is not controlled, and there are no plans for control.
- •Subject has more than 10 lung nodules.
结局指标
主要结局
Efficacy of microwave ablation.
时间窗: 3 months
Efficacy is defined as achieving the technical success = complete ablation = achieving ablation zone size predicted/necessary for treatment.
Assessment of patient adverse events as defined by CTCAE.
时间窗: 3 months
The safety evaluation is based on the major complication rates of performing microwave ablation. The intent is to determine if the results are within acceptable range of what is reported for RFA, cryoablation and surgery. If the microwave ablation has a safety profile that is outside the "standard of care" range, then the procedure would be deemed unacceptable and no further studies of the current generation of microwave ablation would be recommended. The study team has deemed major complication rates of 50% or greater as outside of the "standard of care" range.
次要结局
- Pathological response in patients receiving microwave ablation.(1 year)
研究者
Shanda Blackmon, M.D., M.P.H.
Principal Investigator
Mayo Clinic