None listed
Conditions
Brief summary
The aim of this study is to evaluate the safety and feasibility of Endobronchial thermal liquid ablation (ETLA-LC) for the Treatment of Pulmonary Cancer Lesions. Who is this for? You may be eligible for this study if you are a male or female age 18 or older with non small cell lung cancer that is scheduled for lobectomy. Study details: Participants will receive a bronchoscopic procedure which delivers heated normal saline to targeted region(s) where the lung tumour resides. The heated saline causes coagulative necrosis of the tumour and surrounding vasculature that feeds the tumour, and the heated saline takes a margin around the tumour as well. Participants will undergo surgical lobectomy as their standard of care 5 - 14 days after undergoing the bronchoscopy with heated saline. Pathology on the removed lung tissue (and area treated with heated normal saline) will be performed to confirm complete tumour kill. It is hoped that findings from this study will show that the heated saline completely kills the tumour and therefore, provides an option for a procedure to kill a cancerous tumour in patients that cannot tolerate lung surgery.
Interventions
The Morair Medtech Endobronchial Thermal Liquid Ablation - Lung Cancer (ETLA-LC) is a medical device consisting of an ETLA-LC catheter, generator and Lung Cancer Treatment Tool (LCTT). The ETLA-LC System is a minimally invasive bronchoscopic treatment designed to deliver heated normal saline to targeted region(s) in which a lung tumour resides.
The REMOVE study involves the completion of a single procedure using the ETLA-LC System in the bronchoscopy suite by a trained interventional pulmonary
The Morair Medtech Endobronchial Thermal Liquid Ablation - Lung Cancer (ETLA-LC) is a medical device consisting of an ETLA-LC catheter, generator and Lung Cancer Treatment Tool (LCTT). The ETLA-LC System is a minimally invasive bronchoscopic treatment designed to deliver heated normal saline to targeted region(s) in which a lung tumour resides. The REMOVE study involves the completion of a single procedure using the ETLA-LC System in the bronchoscopy suite by a trained interventional pulmonary physician (respiratory physician). The subject will receive aenesthesia and paralytics for the procedure, and the total procedure time is estimated to take about 30 minutes. The treatment will occur 5 to 14 days before the scheduled lobectomy. After the ETLA-LC procedure and immediately prior to the surgical lobectomy additional safety tests will be performed including pulmonary function tests, labs, and another CT scan. After lobectomy, pathology on the treatment region will be performed to confirm percent of tumor killed, vascular impact and margin. ETLA-LC therapy involves the delivery of up to 57ml of heated normal saline (0.9% Normal Saline) at 95 degrees Celsius to the lung regions that contain the identified tumor using the LCTT. The LCTT allows creation of a treatment plan based on the analysis of the high-resolution computed tomography (HRCT) of the subject's chest that provides direction and information to the interventional pulmonologist prior to the procedure. The heated normal saline delivered to the specified tumour areas will cause coagulative necrosis of the tumour and surrounding vasculature feeding the tumour, as well as margin. The goal being complete tumour kill.
Sponsors
Morair Medtech, Pty. Ltd
Avania Pty Ltd
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
General Inclusion Criteria -Age greater than or equal to 18 years old -Non-small cell lung cancer tumor(s) suitable for lobectomy -Suitable candidate for lobectomy as per standard of care -Pathologically confirmed malignancy obtained via bronchoscopic biopsy with adequate yield to perform definitive diagnosis -Cognitively able to provide written informed consent Radiographic Inclusion Criteria -Longest axis of tumor less than 3cm per HRCT analysis by QCT Core lab -Tumor is identified in the periphery of lung (outer 2/3rd) by radiologic reviewer in addition to site radiologist. -Tumor resides in eligible segment(s) per HRCT analysis by QCT Core lab, with target treatment location not adjacent to lobar fissure planned for resection, and assessed by surgeon -Tumor resides within two or fewer eligible segments per HRCT analysis by QCT Core lab with treatment at the segmental or subsegmental level.
Exclusion criteria
General Exclusion Criteria -Post-bronchodilator FEV1 of less than 40% predicted or recent COPD exacerbation requiring treatment within 1 year of screening -DLCO less than 40% predicted -Supplemental oxygen at rest or during exercise -Hospitalization for cardiac event within 6 months of screening -Liver enzymes (AST, ALT, ALP) or total bilirubin more than 1.5 times upper limit of normal (ULN) -Serum creatinine greater than 2 mg/dL -Receiving immunosuppressive medication or prednisone greater than 15 mg/day (or equivalent) -Receiving adjunct chemotherapy -Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception. -History of severe hemoptysis or persistent hemoptysis. -Disorder of coagulation or receiving anticoagulant and/or antiplatelet medication. Note: Antiplatelet/anticoagulant medication is permitted provided that the medication can be held per physician discretion based on specific agent prior to the procedure and through to planned surgical resection. -Unablated tumor tissue is required from the resection to inform patient’s ongoing cancer treatment. -Any condition that in the opinion of the investigator may interfere with the safety of the patient or evaluation of the study objectives. -Any condition that would interfere with completion of the study including study assessments and procedures. -Any tumor characteristic that in the opinion of the investigator may interfere with the safety of the patient or evaluation of the study objectives. -Currently enrolled in another trial studying an experimental treatment that in the opinion of the investigator may impact this study. Radiographic Exclusion Criteria -Tumor invading beyond pleura into chest wall NOTE: HRCT analysis by QCT Core Lab Tumor invading beyond pleura into check wall assessed by Radiologic Eligibility Reviewer in addition to site radiology Pre-procedural Exclusion Criteria -Active respiratory infection or recent respiratory infection with resolution less than 4 weeks prior to screening or procedure.
Outcome results
None listed