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 range18 Years
SexALL
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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
✓. 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
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
✕. 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)