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

Primary Purpose

Non Small Cell Lung Cancer, Metastatic Lung Cancer, Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Bronchoscopic Thermal Vapor Ablation

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, Metastatic Lung Cancer, Lung Cancer, Vapor Ablation, BTVA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
1. In periphery of lung (outermost 1/3)
2. Anticipation that resection would remove all gross tumor and ablation with grossly negative margins
3. Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan
Signed informed consent

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)
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

Sites / Locations

The Royal Melbourne Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vapor Ablation

Arm Description

Outcomes

Primary Outcome Measures

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.

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

Ischemic tissue assessment

CT Imaging to identify and assess ischemic tissue

Tissue necrosis evaluated by semi-quantitative histological analysis

Semi-quantitative scoring of necrotic tissue assessed by histology

Secondary Outcome Measures

Full Information

NCT ID

NCT03198468

First Posted

June 14, 2017

Last Updated

November 6, 2021

Sponsor

Uptake Medical Technology, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03198468

Brief Title

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

Acronym

VAPORIZE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

November 21, 2018 (Actual)

Primary Completion Date

August 20, 2019 (Actual)

Study Completion Date

August 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Uptake Medical Technology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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. Subjects identified for this study will be those that have a surgical resection already scheduled as part of their lung cancer treatment. Patients who have consented to participate in this study (enrolled) will undergo screening assessments to evaluate the inclusion criteria associated with their lung cancer and general health. Only patients that meet all of the inclusion criteria and none of the exclusion criteria will be scheduled for treatment with the BTVA-C System. A total of 8 subjects will be treated at up to 2 investigational sites in Australia. Prior to the vapor ablation procedure, the patient's CT scan is analyzed to evaluate the location and size of the target lesion. The segments and airways associated with the lesion are identified and images are created to aid in the navigation to appropriate treatment locations during the upcoming procedure. At the time of the vapor ablation procedure, the Uptake catheter is placed in a selected airway with a thin bronchoscope. A balloon at the distal end of the catheter is then inflated to occlude the bronchus prior to vapor infusion. Sterile water is heated to approximately 100°-140°C by a reusable Generator and vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power. If necessary, the catheter is moved to the next airway and the procedure is repeated until all desired airways have been treated (maximum 3 treatments). The treatment creates a uniform field of necrosis in the parenchyma around the lesion. The interval between vapor ablation and the surgical resection will be a minimum of 60 hours to a maximum of 105 hours, with the exact scheduling determined by the investigator. The resected tissue will undergo pathological evaluation for tissue viability. In addition to standard post-operative follow-up, patients will be evaluated at Day 7 (± 2 days) and Day 30 (± 5 days) post-resection to assess safety and feasibility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer, Metastatic Lung Cancer, Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vapor Ablation

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Bronchoscopic Thermal Vapor Ablation

Intervention Description

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).

Primary Outcome Measure Information:

Title

AEs and SAEs related to BTVA-C procedure

Description

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

Time Frame

Day 30 follow-up

Title

Successful BTVA-C Treatment Delivery

Description

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

Time Frame

1 day post-ablation

Title

Ischemic tissue assessment

Description

CT Imaging to identify and assess ischemic tissue

Time Frame

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

Title

Tissue necrosis evaluated by semi-quantitative histological analysis

Description

Semi-quantitative scoring of necrotic tissue assessed by histology

Time Frame

1 day post-surgical resection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Signed informed consent 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) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Steinfort, MD, PhD

Organizational Affiliation

Melbourne Health, The Royal Melbourne Hospital, City Campus.

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Royal Melbourne Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.uptakemedical.com/

Description

Uptake Medical Website

Learn more about this trial

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

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