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Trial registered on ANZCTR


Registration number
ACTRN12620000613909
Ethics application status
Approved
Date submitted
29/04/2020
Date registered
26/05/2020
Date last updated
26/05/2020
Date data sharing statement initially provided
26/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to assess safety and feasibility of bronchoscopic radiofrequency ablation in non-small cell lung cancer delivered via the EUSRA™ probe.
Scientific title
Pilot study to assess safety and feasibility of bronchoscopic radiofrequency ablation in non-small cell lung cancer delivered via the EUSRA™ probe.
Secondary ID [1] 301143 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lung cancer - Non small cell lung cancer 317260 0
Cancerous/Malignant lung lesions 317261 0
Condition category
Condition code
Respiratory 315391 315391 0 0
Other respiratory disorders / diseases
Cancer 315393 315393 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Radiofrequency ablation (RFA) is delivered to targeted lung lesions (Cancerous lesions). Radiofrequency ablation is the delivery of measured dose radiofrequency energy into a cancerous lesion.

RFA will be delivered bronchoscopically via the EUSRA™ (Taewong, South Korea) 19-gauge RFA needle in conjunction with the VIVA combo™ RF generator (Taewong, South Korea). The needle will be dispatched using the linear endobronchial ultrasound (EBUS) scope. The linear EBUS scope will allow direct real-time ultrasound guidance of the EUSRA™ needle into the cancerous lesion. The needle will be inserted into the cancerous lesion and radiofrequency energy between 10 to 30 watts, generated from the VIVA combo™ RF generator will be administered. Wattage will be determined by the clinician performing the procedure and will depend on the size of the target lesion. The cancerous lesion will be identified prior to procedure using CT imaging.

The procedure will be performed by an interventional pulmonologist (respiratory physician) in a bronchoscopy suite within a hospital. It will be performed in a single bronchoscopic procedure prior to lung resection. Echogenic bubbling on EBUS image will represent adequate ablation, this will be monitored by the interventional pulmonologist during the procedure to determine adequate ablation. The procedure will generally take less than 60 minutes to perform. Lung resection will then occur according to standard hospital procedures.

The interval between ablation and resection will be a maximum of 2 weeks. Degree of tissue damage/necrosis from ablation will be determined post procedure by a pathologist to determine efficacy of ablation.
Intervention code [1] 317467 0
Treatment: Devices
Comparator / control treatment
Nil comparator or control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323656 0
Primary outcome: Safety

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 radiofrequency ablation procedure. Possible or known adverse events associated with the investigational device/procedure may include:

The possible risks associated with bronchoscopy:
1. Very Common (>50%) - none.
2. Common (between 10% and 50% - Sore throat, Injury to teeth, Bleeding.
3. 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 oedema, Cardiac arrest, Spasm of the muscles in your airway and / or voice box, Death.

The possible risks of the Radiofrequency Ablation treatment:
1. Very Common (>50%) - None.
2. Common (between 10% and 50%) - Bronchitis or pneumonitis (airway inflammation), Cough, Minor bleeding, Pain at the treatment site, Respiratory distress.
3. Uncommon (between 1% and 10%) - Fever, Fatigue, Loss of appetite, Pneumonia, Infection, 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.
4. Rare (<1%) - Haemothorax (blood between the chest wall and lungs), Cardiac arrhythmias, Myocardial infarction (heart attack), Oesophageal injury, Nerve injury, Brain damage, Death
Timepoint [1] 323656 0
Timepoint: up to and including 30 days post-surgical resection
Secondary outcome [1] 382505 0
Secondary Outcome 1: Feasibility

Feasibility of radiofrequency ablation treatment via the EUSRA™ ablation needle will be determined by assessing the following:

1. Successful delivery of radiofrequency ablation treatment as per treatment plan
2. Histological evidence of ablation using a H&E tissue viability stain to assess the extent of the coagulative necrotic zone in relation to the tumour focus, as well as zones of temporary inflammation and oedema.
3. CT imaging, between ablation and resection procedures, to identify the extent of treatment areas.
Timepoint [1] 382505 0
Timepoint: During and at completion of radiofrequency ablation.
Secondary outcome [2] 382506 0
Secondary Outcome 2: Changes to tumour microenvironment and tumour immunogenicity as a result of ablation.

Changes to tumour microenvironment and tumour immunogenicity as a result of thermal injury from radiofrequency ablation will be determined by assessing the following:
1. Changes in immune cell populations within the tumour pre and post ablation measured via multiplex immunohistochemistry.
2. Changes in immune cell populations within tumour pre and post ablation measured via mass cytometry.
3. Changes in immune cell populations in blood pre and post ablation measured via mass cytometry.
Timepoint [2] 382506 0
Timepoint: Baseline (tissue, blood), post ablation at time of resection (tissue, blood), post resection day 7 (blood), post resection day 30 (blood).

Eligibility
Key inclusion criteria
1. Age: greater than or equals to 18 years old

2. Non-small cell lung cancer tumour(s) suitable for resection

3. Suitable candidate for resection per standard of practice (lobectomy)

4. Microscopic proof of malignancy of lung cancer lesion to be ablated obtained.

5. Location of tumour:
a. Centrally located tumour that is accessible via linear EBUS scope
b. Anticipation that resection (lobectomy) would remove all gross tumour and
ablation with grossly negative margins

6. Signed informed consent as prescribed by hospital policies.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The following lesions should be excluded from the study for safety reasons:
a. Unable to access tumour with linear EBUS scope.
b. Tumour less than 2cm in size.
c. Tumours that are less than 2cm from major pulmonary artery vasculature (as
assessed by CT)

2. Carcinoid lung tumours

3. Tumour 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 greater than 2 mg/dl

9. Recent infection (within 30 days)

10. Receiving immunosuppressive medication or prednisone greater than 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 haemoptysis, 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 tumour 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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
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
Not yet recruiting
Date of first participant enrolment
Anticipated
8/06/2020
Actual
Date of last participant enrolment
Anticipated
30/01/2021
Actual
Date of last data collection
Anticipated
12/03/2021
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16590 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 30179 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 305586 0
Hospital
Name [1] 305586 0
Respiratory Department, Royal Melbourne Hospital
Country [1] 305586 0
Australia
Primary sponsor type
Hospital
Name
Respiratory Department, Royal Melbourne Hospital
Address
300 Grattan St
Parkville
Vic 3050
Country
Australia
Secondary sponsor category [1] 305999 0
None
Name [1] 305999 0
Address [1] 305999 0
Country [1] 305999 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305886 0
Melbourne Health
Ethics committee address [1] 305886 0
Ethics committee country [1] 305886 0
Australia
Date submitted for ethics approval [1] 305886 0
Approval date [1] 305886 0
27/08/2019
Ethics approval number [1] 305886 0
HREC/17/MH/286

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

Contacts
Principal investigator
Name 101938 0
Dr Kanishka Rangamuwa
Address 101938 0
Respiratory Department
Royal Melbourne Hospital
300 Grattan St
Parkville, Vic 3050
Country 101938 0
Australia
Phone 101938 0
+61 03 9342 7000
Fax 101938 0
Email 101938 0
kanishka.rangamuwa@mh.org.au
Contact person for public queries
Name 101939 0
Kanishka Rangamuwa
Address 101939 0
Respiratory Department
Royal Melbourne Hospital
300 Grattan St
Parkville, Vic 3050
Country 101939 0
Australia
Phone 101939 0
+61 03 9342 7000
Fax 101939 0
Email 101939 0
kanishka.rangamuwa@mh.org.au
Contact person for scientific queries
Name 101940 0
Kanishka Rangamuwa
Address 101940 0
Respiratory Department
Royal Melbourne Hospital
300 Grattan St
Parkville, Vic 3050
Country 101940 0
Australia
Phone 101940 0
+61 03 9342 7000
Fax 101940 0
Email 101940 0
kanishka.rangamuwa@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
de-identified data only will be presented in any consequent publciations as per IRB approval


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.