None listed
Conditions
Brief summary
The purpose of this study is to examine the feasibility and safety of a device for ablating cancerous lung tumors using a technique called radiofrequency ablation. Who is it for? You may be eligible for this study if you are aged 18 or older and are a suitable candidate for resection of a lung cancer tumor. Study details All participants will receive one treatment of radiofrequency ablation via a bronchoscope (tube down the throat), 2-14 days before undergoing their scheduled surgical lung resection. The treatment takes place under general anaesthetic in a day surgery procedure area. All participants will be followed-up using standard hospital procedures. It is hoped that this research will provide information into the non-surgical treatments of lung cancer, thereby providing future non-surgery related options for the disease.
Interventions
Radiofrequency Ablation delivered to target lung areas (Cancerous Lesions). Radiofrequency Ablation involves the delivery of a measured dose of radiofrequency energy to the area surrounding the cancerous lesion.
The radiofrequency ablation will be delivered by an interventional pulmonologist (respiratory physician) in a bronchoscopy suite within a hospital.
Dose(s) of up to 80 watts of energy is delivered to targeted lung lesions (according to a CT guided therapy plan) during a single bronchosco
Radiofrequency Ablation delivered to target lung areas (Cancerous Lesions). Radiofrequency Ablation involves the delivery of a measured dose of radiofrequency energy to the area surrounding the cancerous lesion. The radiofrequency ablation will be delivered by an interventional pulmonologist (respiratory physician) in a bronchoscopy suite within a hospital. Dose(s) of up to 80 watts of energy is delivered to targeted lung lesions (according to a CT guided therapy plan) during a single bronchoscopic procedure prior to lung resection. This procedure will generally take less than 60 minutes to perform. Lung resection will then occur according to the standard hospital procedures. Subjects will be treated with Radiofrequency ablation and the interval between ablation and resection will be a minimum of 48 hours to a maximum of 2 weeks, with the exact scheduling determined by the investigator.
Sponsors
Zidan Medical Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed