Vapor Ablation for Localized Cancer Lesions of the Lung (VAPORIZE) (NCT03198468) | Clinical Trial Compass
CompletedNot Applicable
Vapor Ablation for Localized Cancer Lesions of the Lung (VAPORIZE)
Australia8 participantsStarted 2018-11-21
Plain-language summary
This study is a prospective, single-arm, multi-center, pilot trial of Bronchoscopic Thermal Vapor Ablation for Lung Cancer (BTVA-C) in patients with primary lung cancer or metastatic cancer in the lung. Patients who have consented to participate in this study (enrolled) will be subject to eligibility screening and baseline assessments, prior to undergoing the BTVA-C procedure. Only patients that meet all of inclusion criteria and none of the exclusion criteria will receive vapor ablation treatment.
Patients will receive BTVA-C treatment followed by standard-of-practice surgical resection.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: ≥ 18 years old
. Non-small cell lung cancer tumor(s) ≤ 2cm (T1aN0, T1bN0, T1aN1, or T1bN1) suitable for resection OR Metastatic lung tumor(s) ≤ 2cm suitable for resection
. Suitable candidate for resection per standard of practice
. Microscopic proof of malignancy obtained.
. Location of tumor:
. In periphery of lung (outermost 1/3)
. Anticipation that resection would remove all gross tumor and ablation with grossly negative margins
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AEs and SAEs related to BTVA-C procedure
Timeframe: Day 30 follow-up
2
Successful BTVA-C Treatment Delivery
Timeframe: 1 day post-ablation
3
Ischemic tissue assessment
Timeframe: 2-4 days post-ablation (pre surgical resection)
4
Tissue necrosis evaluated by semi-quantitative histological analysis
. Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan
Exclusion criteria
. Centralized tumor not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea)
. Carcinoid lung tumors
. Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion
. 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
. Requirement for supplemental oxygen at rest or exercise
. Hospitalization for cardiac disease within the preceding 6 months
. Liver enzymes (ALP, ALT, AST) or total bilirubin \> 1.5 upper limit of normal (ULN)