None listed
Conditions
Brief summary
The purpose of this study is to assess the feasibility and safety of a minimally invasive treatment technique in the treatment of lung cancer called bronchoscopic (tube down the throat) 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 surgical resection of a lung cancer tumour. Study Details All participants will receive one treatment of radiofrequency ablation via a bronchoscope. This will be performed 2 to 14 days prior to undergoing their scheduled surgical lung resection. The procedure will be performed under a general anaesthetic in a day surgery area. All patients will be followed up using standard hospital procedure. The aim of this research is to provide information into non-surgical treatment options for lung cancer and as such will provide future non-surgical related options for the disease.
Interventions
Radiofrequency ablation (RFA) is delivered to targeted lung lesions (Cancerous lesions). Radiofrequency ablation is the delivery of measured dose radiofrequency energy into a cancerous lesion.
RFA will be delivered bronchoscopically via the EUSRA™ (Taewong, South Korea) 19-gauge RFA needle in conjunction with the VIVA combo™ RF generator (Taewong, South Korea). The needle will be dispatched using the linear endobronchial ultrasound (EBUS) scope. The linear EBUS scope will allow direct real-time
Radiofrequency ablation (RFA) is delivered to targeted lung lesions (Cancerous lesions). Radiofrequency ablation is the delivery of measured dose radiofrequency energy into a cancerous lesion. RFA will be delivered bronchoscopically via the EUSRA™ (Taewong, South Korea) 19-gauge RFA needle in conjunction with the VIVA combo™ RF generator (Taewong, South Korea). The needle will be dispatched using the linear endobronchial ultrasound (EBUS) scope. The linear EBUS scope will allow direct real-time ultrasound guidance of the EUSRA™ needle into the cancerous lesion. The needle will be inserted into the cancerous lesion and radiofrequency energy between 10 to 30 watts, generated from the VIVA combo™ RF generator will be administered. Wattage will be determined by the clinician performing the procedure and will depend on the size of the target lesion. The cancerous lesion will be identified prior to procedure using CT imaging. The procedure will be performed by an interventional pulmonologist (respiratory physician) in a bronchoscopy suite within a hospital. It will be performed in a single bronchoscopic procedure prior to lung resection. Echogenic bubbling on EBUS image will represent adequate ablation, this will be monitored by the interventional pulmonologist during the procedure to determine adequate ablation. The procedure will generally take less than 60 minutes to perform. Lung resection will then occur according to standard hospital procedures. The interval between ablation and resection will be a maximum of 2 weeks. Degree of tissue damage/necrosis from ablation will be determined post procedure by a pathologist to determine efficacy of ablation.
Sponsors
Respiratory Department, Royal Melbourne Hospital
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 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.
Exclusion criteria
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
Outcome results
None listed