Vapor Ablation for Localized Cancer Lesions of the Lung (VAPORIZE)

NCT03198468 | Completed DMC

• 1 other identifier: CSP-2402
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non Small Cell Lung Cancer; Metastatic Lung Cancer; Lung Cancer

Keywords

Non Small Cell Lung Cancer; Metastatic Lung Cancer; Lung Cancer; Vapor Ablation; BTVA

Outcome Measures

Primary Outcomes (4)

• AEs and SAEs related to BTVA-C procedure

  The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure.

  Day 30 follow-up

• Successful BTVA-C Treatment Delivery

  Treatment meets 100% of the required procedural steps/requirements per the Instructions For Use (IFU) and treatment is delivered to the target tumor per the individual patient navigational plan

  1 day post-ablation

• Ischemic tissue assessment

  CT Imaging to identify and assess ischemic tissue

  2-4 days post-ablation (pre surgical resection)

• Tissue necrosis evaluated by semi-quantitative histological analysis

  Semi-quantitative scoring of necrotic tissue assessed by histology

  1 day post-surgical resection

Study Arms (1)

Vapor Ablation

EXPERIMENTAL

Device: Bronchoscopic Thermal Vapor Ablation

Interventions

Bronchoscopic Thermal Vapor Ablation DEVICE

Vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power (an energy level of 330 calories).

Vapor Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed informed consent

You may not qualify if:

• 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)
• Serum creatinine \> 2 mg/dl
• Recent infection (within 30 days)
• Receiving immunosuppressive medication or prednisone \> 10 mg/day (or equivalent)
• Pre-existing implants within the airways that impede navigation to the target lesion
• Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception
• 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.
• 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
• 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

Sponsors & Collaborators

• Uptake Medical Technology, Inc.: lead

Study Sites (1)

The Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Related Links

• Uptake Medical Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Daniel Steinfort, MD, PhD

  Melbourne Health, The Royal Melbourne Hospital, City Campus.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 26, 2017
• Study Start: November 21, 2018
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)