Phase I Study of Transarterial Chemoembolization of Lung Metastases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Participant toxicity will be evaluated according to CTCAE v5.0
研究概览
简要总结
This study is being done to determine if it is safe to perform lung chemoembolization and if the lung chemoembolization procedure can successfully deliver chemotherapy to lung tumors.
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
- •Lung, endobronchial, pleural, or mediastinal metastases that are not responding to systemic chemotherapy, and that are not amenable to ablation, resection, or SBRT.
- •At least 18 years old.
- •ECOG performance status 0 or 1
排除标准
- •Primary lung cancer
- •>50% of a lung is replaced with tumor
- •Oxygen saturation <92% on room air
- •FEV1 <60%
- •Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, MRI, or direct pressure measurement)
- •Recent pulmonary embolism (within 3 months)
- •Pulmonary arteriovenous malformation
- •Active lung infection (pneumonia, empyema, or lung abscess requiring therapy within 1 month)
- •Symptomatic heart failure (dyspnea, volume overload)
- •Left bundle branch block (contraindication to pulmonary angiography)
- •Renal failure (eGFR <30 mL/min/1.73m^2)
- •Pregnancy
- •Breastfeeding
- •Altered mental status that would interfere with consent or follow-up
- •Platelets < 100,000 (after transfusion, if needed)
- •INR>2 (after transfusion, if needed)
- •Hemoglobin <7 (after transfusion, if needed)
- •Hyperthyroidism (contraindication to lipiodol)
- •Planned radioactive iodine imaging or therapy (contraindication to lipiodol)
- •Allergy to lipiodol or mitomycin
- •Allergy to iodinated contrast that can not be treated with steroid / diphenhydramine premedication
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
研究组 & 干预措施
Lung, Endobronchial, Mediastinal or Pleural Metastases
Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy
干预措施: Chemoembolization (Procedure)
Lung, Endobronchial, Mediastinal or Pleural Metastases
Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy
干预措施: Mitomycin C (Drug)
Lung, Endobronchial, Mediastinal or Pleural Metastases
Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy
干预措施: Lipiodol (Drug)
Lung, Endobronchial, Mediastinal or Pleural Metastases
Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy
干预措施: Embospheres (Drug)
结局指标
主要结局
Participant toxicity will be evaluated according to CTCAE v5.0
时间窗: Up to 12 months post treatment
Safety will be evaluated by participant toxicity according to CTCAE v5.0
次要结局
未报告次要终点