ACTRN12620000613909尚未招募未知
Pilot study to assess safety and feasibility of bronchoscopic radiofrequency ablation in non-small cell lung cancer delivered via the EUSRA™ probe.
Respiratory Department, Royal Melbourne Hospital0 个研究点目标入组 20 人开始时间: 2020年5月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Age: greater than or equals to 18 years old
- •2.Non-small cell lung cancer tumour(s) suitable for resection
- •3.Suitable candidate for resection per standard of practice (lobectomy)
- •4.Microscopic proof of malignancy of lung cancer lesion to be ablated obtained.
- •5.Location of tumour:
- •a.Centrally located tumour that is accessible via linear EBUS scope
- •b.Anticipation that resection (lobectomy) would remove all gross tumour and
- •ablation with grossly negative margins
- •6.Signed informed consent as prescribed by hospital policies.
排除标准
- •1.The following lesions should be excluded from the study for safety reasons:
- •a.Unable to access tumour with linear EBUS scope.
- •b.Tumour less than 2cm in size.
- •c.Tumours that are less than 2cm from major pulmonary artery vasculature (as
- •assessed by CT)
- •2.Carcinoid lung tumours
- •3.Tumour is associated with atelectasis or obstructive pneumonitis or pleural effusion
- •4.Pulmonary function tests (PFTs): post-bronchodilator forced expired volume in one second (FEV1) or forced vital capacity (FVC) < 50% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) <50% predicted
- •5.Requirement for supplemental oxygen at rest or exercise
- •6.Hospitalization for cardiac disease within the preceding 6 months
- •7.Liver enzymes (ALP, ALT, AST) or total bilirubin > 1.5 upper limit of normal (ULN)
- •8.Serum creatinine greater than 2 mg/dl
- •9.Recent infection (within 30 days)
- •10.Receiving immunosuppressive medication or prednisone greater than 10 mg/day (or equivalent)
- •11.Pre-existing implants within the airways that impede navigation to the target lesion
- •12.Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
- •13.Disorder of coagulation, history of severe haemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedure and 10 days, post-procedure.
- •14.Any condition that in the opinion of the investigator or reviewer may interfere with the safety of the patient or evaluation of the study objectives
- •15.Any tumour characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives
研究者
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