Pilot study to assess safety and feasibility of bronchoscopic radiofrequency ablation in non-small cell lung cancer delivered via the EUSRA™ probe.

Not Applicable

• Conditions: lung cancer - Non small cell lung cancer; Cancerous/Malignant lung lesions; Respiratory - Other respiratory disorders / diseases; Cancer - Lung - Non small cell

• Registration Number: ACTRN12620000613909
• Lead Sponsor: Respiratory Department, Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-26
• Last Update Posted: 1 June 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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.

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

• Study Type: Interventional
• Study Design: Not specified