Vapor Ablation for Localized Cancer Lesions of the Lung – A Clinical Feasibility Treat-and-Resect Study (VAPORIZE)

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 6

Inclusion Criteria

1.Age: equal to or greater than 18 years old
2.Non-small cell lung cancer tumor(s) equal to or less than 2cm in diameter (T1aN0, T1bN0, T1aN1, or T1bN1) suitable for resection
OR
Metastatic lung tumor(s) equal to or less than 2cm suitable for resection
3.Suitable candidate for resection per standard of practice
4.Microscopic proof of malignancy obtained.
5.Location of tumor:
a.In periphery of lung (outermost one third)
b.Anticipation that resection would remove all gross tumor and ablation with grossly negative margins
c.Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan
6.Signed informed consent

Exclusion Criteria

1.Centralized tumor not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea)
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 > 2 mg/dl
9.Recent infection (within 30 days)
10.Receiving immunosuppressive medication or prednisone > 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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