Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001748202
Ethics application status
Approved
Date submitted
19/10/2018
Date registered
24/10/2018
Date last updated
24/04/2019
Date data sharing statement initially provided
24/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Vapor Ablation for Localized Cancer Lesions of the Lung – A Clinical Feasibility Treat-and-Resect Study (VAPORIZE)
Scientific title
Vapor Ablation for Localized Cancer Lesions of the Lung – A Clinical Feasibility Treat-and-Resect Study (VAPORIZE)
Secondary ID [1] 296374 0
None
Universal Trial Number (UTN)
Trial acronym
Uptake Medical VAPORIZE Clinical Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancerous / Malignant Lung Lesions 310116 0
Condition category
Condition code
Respiratory 308866 308866 0 0
Other respiratory disorders / diseases
Cancer 308885 308885 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thermal Vapor Ablation delivered to target lung areas (Cancerous Lesions). Thermal Vapor Ablation involves the delivery of a measured dose boiling water to the area surrounding the cancerous lesion.
The Vapor ablation will be delivered by an interventional pulmonologist (respiratory physician) in a bronchoscopy suite within a hospital.
One dose of 330 calories of energy is delivered to targeted lung lesions (according to a CT guided therapy plan) during a single bronchoscopic procedure prior to lung resection. This procedure will generally take less than 30 minutes to perform.
Lung resection will then occur according to the standard hospital procedures.
Subjects will be treated with Thermal Vapor Ablation (BTVA-C) and the interval between ablation and resection will be a minimum of 60 hours to a maximum of 105 hours, with the exact scheduling determined by the investigator.
Intervention code [1] 312709 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307837 0
Safety will be evaluated as the 30-day (or date of Day 30 follow-up) number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure.
Possible or known adverse events associated with the investigational device / procedure may include:
The possible risks associated with bronchoscopy:
Very Common (>50%)
- none
Common (between 10% and 50%)
- Sore throat
- Injury to teeth
- Bleeding

Uncommon (between 1% and 10%)
- Asthma-like reaction
- Fever

Rare (<1%)
- Infection (higher risk for smokers)
- Thrombosis (blood clot) in legs
- Pneumothorax
- Myocardial infarction (heart attack)
- Pulmonary enema
- Cardiac arrest
- Spasm of the muscles in your airway and / or voice box
- Death

The possible risks of the BTVA-C treatment:
Very Common (>50%)
- None

Common (between 10% and 50%)
- Bronchitis or pneumonitis (airway inflammation)
- Cough
- Minor bleeding
- Pain at the treatment site
- Respiratory distress

Uncommon (between 1% and 10%)
- Fever o Fatigue
- Loss of appetite
- Pneumonia
- Damage to lung lobes, chest wall or heart
- Pleural effusion (fluid between chest wall and lungs)
- Pericardial effusion (fluid between the heart and the pericardium)
- Pneumothorax (collapsed lung)
- Haemoptysis (coughing up blood)
- Nausea and vomiting

Rare (<1%)
- Haemothorax (blood between the chest wall and lungs)
- Cardiac arrhythmias
- Brain damage
- Death
These possible adverse events will be evaluated by observation following the Vapor Ablation Procedure. CT Scans may be used to evaluate the impact of the Vapor Ablation on lung tissue if determined as required by the investigator.
Timepoint [1] 307837 0
30 days post BTVA-C procedure
Secondary outcome [1] 353091 0
Feasibility will be evaluated by assessing the ability of the BTVA-C System to achieve successful delivery of the thermal vapor ablation treatment according to the Instructions for Use (IFU) and navigation plan.
• Histological evidence of ablation using a tetrazolium based tissue viability stain to assess the extent and characteristics of the primary mechanism of thermal vapor ablation as well as secondary mechanisms (ischemia, nutrient depletion, apoptosis, necroptosis, etc.) in relation to the tumor focus.
• CT imaging, between ablation and resection procedures, to identify ischemic tissue within the treatment areas.
Timepoint [1] 353091 0
During and at the completion of the BTVA-C Procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Phase 1 safety and feasibility study not powered for a result

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2018
Actual
14/12/2018
Date of last participant enrolment
Anticipated
1/11/2019
Actual
Date of last data collection
Anticipated
30/11/2019
Actual
Sample size
Target
6
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 12212 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 24389 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 24391 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 300979 0
Commercial sector/Industry
Name [1] 300979 0
Uptake Medical Inc.
Country [1] 300979 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Uptake Medical Inc.
Address
936 N 34th St, STE 200
Seattle, WA USA 98103
Country
United States of America
Secondary sponsor category [1] 300563 0
None
Name [1] 300563 0
Address [1] 300563 0
Country [1] 300563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301742 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 301742 0
Ethics committee country [1] 301742 0
Australia
Date submitted for ethics approval [1] 301742 0
29/11/2017
Approval date [1] 301742 0
18/01/2018
Ethics approval number [1] 301742 0
2017.317
Ethics committee name [2] 301744 0
Macquarie University Human Research Ethics Committee HREC Medical Sciences Committee
Ethics committee address [2] 301744 0
Ethics committee country [2] 301744 0
Australia
Date submitted for ethics approval [2] 301744 0
12/06/2018
Approval date [2] 301744 0
04/09/2018
Ethics approval number [2] 301744 0
5201830364196

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55058 0
A/Prof Daniel Steinfort
Address 55058 0
The Royal Melbourne Hospital
Dept Respiratory Medicine
Grattan Street
PARKVILLE VIC 3050
Country 55058 0
Australia
Phone 55058 0
+61 03 9342 7708
Fax 55058 0
Email 55058 0
[email protected]
Contact person for public queries
Name 55059 0
Matthew Godden
Address 55059 0
Australian Healthcare Solutions Pty Ltd
P.O. Box 3270
The Pines
Doncaster East, Vic 3109
Country 55059 0
Australia
Phone 55059 0
+ 61400007127
Fax 55059 0
Email 55059 0
[email protected]
Contact person for scientific queries
Name 55060 0
Julie Arneson
Address 55060 0
Uptake Medical Inc.
936 N 34th St, STE 200
Seattle, WA USA 98103
Country 55060 0
United States of America
Phone 55060 0
0011 1 206 926 7414
Fax 55060 0
Email 55060 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data not availble


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.