ACTRN12619001663145Not yet recruiting未知
Radiofrequency ablation Of Lung cancer followed by EXcision – A Clinical Feasibility Treat-Wait and Resect Study (ROLEX)
Zidan Medical Inc.0 sites12 target enrollmentStarted: November 27, 2019Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1.Age: greater than or equals to years old
- •2.Non-small cell lung cancer tumor(s) less than or equal to 2cm (T1aN0, T1bN0, T1aN1, or T1bN1) suitable for resection OR Metastatic lung tumor(s) less than or equal to 4cm 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 tumor:
- •a.In outer two thirds of lung (outermost 2/3 – located distal to 5th bronchial generation)
- •b.Anticipation that resection (lobectomy) would remove all gross tumor and ablation with grossly negative margins
- •c.One or more radiofrequency ablation applications would target entire margin according to the RFA plan
- •6.Signed informed consent as prescribed by hospital policies.
Exclusion Criteria
- •1.The following lesions should be excluded from the study for safety reasons:
- •a.Centralized tumor (inner most one third) not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea).
- •b.Tumors less than 1cm from any pleural surface
- •c.Tumours that do not have normal lung clearance of less than 1cm around the target lesion.
- •d.Tumours that are less than 2cm from major pulmonary artery vasculature (as assessed by CT)
- •2.Carcinoid lung tumors
- •3.Tumor 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 hemoptysis, 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 tumor characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives
Investigators
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