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Trial registered on ANZCTR


Registration number
ACTRN12624001045505p
Ethics application status
Submitted, not yet approved
Date submitted
27/06/2024
Date registered
28/08/2024
Date last updated
28/08/2024
Date data sharing statement initially provided
28/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The REMOVE Study - Endobronchial Thermal Liquid Ablation - Lung Cancer (ETLA-LC) for the Treatment of Pulmonary Cancer Lesions - A First in Human Treat and Resect Study (CSP-21123)
Scientific title
The REMOVE Study - Endobronchial Thermal Liquid Ablation - Lung Cancer (ETLA-LC) for the Treatment of Pulmonary Cancer Lesions - A First in Human Treat and Resect Study (CSP-21123) for patients with non-small cell lung cancer.
Secondary ID [1] 312413 0
None
Universal Trial Number (UTN)
Trial acronym
REMOVE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 334226 0
Condition category
Condition code
Cancer 330895 330895 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Morair Medtech Endobronchial Thermal Liquid Ablation - Lung Cancer (ETLA-LC) is a medical device consisting of an ETLA-LC catheter, generator and Lung Cancer Treatment Tool (LCTT). The ETLA-LC System is a minimally invasive bronchoscopic treatment designed to deliver heated normal saline to targeted region(s) in which a lung tumour resides.
The REMOVE study involves the completion of a single procedure using the ETLA-LC System in the bronchoscopy suite by a trained interventional pulmonary physician (respiratory physician). The subject will receive aenesthesia and paralytics for the procedure, and the total procedure time is estimated to take about 30 minutes. The treatment will occur 5 to 14 days before the scheduled lobectomy. After the ETLA-LC procedure and immediately prior to the surgical lobectomy additional safety tests will be performed including pulmonary function tests, labs, and another CT scan.
After lobectomy, pathology on the treatment region will be performed to confirm percent of tumor killed, vascular impact and margin.
ETLA-LC therapy involves the delivery of up to 57ml of heated normal saline (0.9% Normal Saline) at 95 degrees Celsius to the lung regions that contain the identified tumor using the LCTT. The LCTT allows creation of a treatment plan based on the analysis of the high-resolution computed tomography (HRCT) of the subject's chest that provides direction and information to the interventional pulmonologist prior to the procedure. The heated normal saline delivered to the specified tumour areas will cause coagulative necrosis of the tumour and surrounding vasculature feeding the tumour, as well as margin. The goal being complete tumour kill.
Intervention code [1] 328918 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338654 0
Safety: Incidence of serious adverse events (SAE) associated with Morair Endobronchial Thermal Liquid Ablation - Lung Cancer System and/or procedure through planned surgical resection post procedure as adjudicated by an independent medical monitor. This includes but is not limited to: device and/or procedure related events requiring ICU admission, SAEs requiring additional procedure (Bronchoscopic or surgical) and death. Adverse events such as mild exacerbation of COPD will be determined primarily by clinical examination and if required the sourcing of de-identified medical records from healthcare providers or institutions.
Timepoint [1] 338654 0
The timepoint is between conduct and completion of the ETLA-LC and immediately prior to surgical resection. No AEs or SAEs will be collected once surgery begins. That is, from ETLA-LC up to planned surgical resection (5 - 14 days post ETLA-LC procedure).
Secondary outcome [1] 436850 0
Feasibility: successful delivery of ETLA-LC to the target lung segment(s) per LCTT (treatment plan).
Timepoint [1] 436850 0
Immediately post-planned surgical resection (5 - 14 days post ETLA-LC procedure).
Secondary outcome [2] 436851 0
Efficacy, Pathological Evidence: Extent of tissue ablation of the tumor and margin
Timepoint [2] 436851 0
Immediately prior to planned surgical resection (5-14 days post ETLA-LC procedure).
Secondary outcome [3] 436853 0
Efficacy, Imaging Evidence: Ability to quantify ischemic tissue within the treated region, post ETLA - LC treatment and prior to surgical resection, as assessed by CT.
Timepoint [3] 436853 0
HRCT scan will occur immediately prior to planned surgical resection (5-14 days post ETLA-LC procedure).
Secondary outcome [4] 436855 0
Prospectively assess the efficacy of ETLA-LC treatment in study subjects with malignant lesions in the lung.
Timepoint [4] 436855 0
CT scan performed post ETLA-LC and immediately before planned surgical resection. for core lab evaluation.

Eligibility
Key inclusion criteria
General Inclusion Criteria
-Age greater than or equal to 18 years old
-Non-small cell lung cancer tumor(s) suitable for lobectomy
-Suitable candidate for lobectomy as per standard of care
-Pathologically confirmed malignancy obtained via bronchoscopic biopsy with adequate yield to perform definitive diagnosis
-Cognitively able to provide written informed consent

Radiographic Inclusion Criteria
-Longest axis of tumor less than 3cm per HRCT analysis by QCT Core lab
-Tumor is identified in the periphery of lung (outer 2/3rd) by radiologic reviewer in addition to site radiologist.
-Tumor resides in eligible segment(s) per HRCT analysis by QCT Core lab, with target treatment location not adjacent to lobar fissure planned for resection, and assessed by surgeon
-Tumor resides within two or fewer eligible segments per HRCT analysis by QCT Core lab with treatment at the segmental or subsegmental level.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General Exclusion Criteria
-Post-bronchodilator FEV1 of less than 40% predicted or recent COPD exacerbation requiring treatment within 1 year of screening
-DLCO less than 40% predicted
-Supplemental oxygen at rest or during exercise
-Hospitalization for cardiac event within 6 months of screening
-Liver enzymes (AST, ALT, ALP) or total bilirubin more than 1.5 times upper limit of normal (ULN)
-Serum creatinine greater than 2 mg/dL
-Receiving immunosuppressive medication or prednisone greater than 15 mg/day (or equivalent)
-Receiving adjunct chemotherapy
-Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
-History of severe hemoptysis or persistent hemoptysis.
-Disorder of coagulation or receiving anticoagulant and/or antiplatelet medication.

Note: Antiplatelet/anticoagulant medication is permitted provided that the medication can be held per physician discretion based on specific agent prior to the procedure and through to planned surgical resection.

-Unablated tumor tissue is required from the resection to inform patient’s ongoing cancer treatment.
-Any condition that in the opinion of the investigator may interfere with the safety of the patient or evaluation of the study objectives.
-Any condition that would interfere with completion of the study including study assessments and procedures.
-Any tumor characteristic that in the opinion of the investigator may interfere with the safety of the patient or evaluation of the study objectives.
-Currently enrolled in another trial studying an experimental treatment that in the opinion of the investigator may impact this study.

Radiographic Exclusion Criteria
-Tumor invading beyond pleura into chest wall
NOTE: HRCT analysis by QCT Core Lab
Tumor invading beyond pleura into check wall assessed by Radiologic Eligibility Reviewer in addition to site radiology

Pre-procedural Exclusion Criteria
-Active respiratory infection or recent respiratory infection with resolution less than 4 weeks prior to screening or procedure.

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
The sample size for this protocol is too small to permit a formal statistical analysis. Descriptive statistics will be used to summarize all safety, feasibility, and efficacy data. Trends, particularly in reported adverse events, will be noted and characterized. A comprehensive listing, categorization, and assessment of causality will be provided for all serious and non-serious adverse events secondary to the ETLA - LC procedure.

Demographics:
Continuous variables, including age, height, and weight, will be summarized in terms of mean, median, standard deviation, minimum, and maximum. Categorical variables, including sex, ethnicity, and race, will be summarized in terms of number of observations available, frequencies and percentages of each possible value.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2025
Actual
Date of last data collection
Anticipated
28/12/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 26734 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 26735 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 26736 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 42781 0
4032 - Chermside
Recruitment postcode(s) [2] 42782 0
3050 - Parkville
Recruitment postcode(s) [3] 42783 0
2109 - Macquarie Park

Funding & Sponsors
Funding source category [1] 316824 0
Commercial sector/Industry
Name [1] 316824 0
Morair Medtech, LLC
Country [1] 316824 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Morair Medtech, Pty. Ltd
Address
Country
United States of America
Secondary sponsor category [1] 319054 0
None
Name [1] 319054 0
Address [1] 319054 0
Country [1] 319054 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315594 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 315594 0
https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
Ethics committee country [1] 315594 0
Australia
Date submitted for ethics approval [1] 315594 0
27/05/2024
Approval date [1] 315594 0
Ethics approval number [1] 315594 0

Summary
Brief summary
The aim of this study is to evaluate the safety and feasibility of Endobronchial thermal liquid ablation (ETLA-LC) for the Treatment of Pulmonary Cancer Lesions.
Who is this for?
You may be eligible for this study if you are a male or female age 18 or older with non small cell lung cancer that is scheduled for lobectomy.
Study details:
Participants will receive a bronchoscopic procedure which delivers heated normal saline to targeted region(s) where the lung tumour resides. The heated saline causes coagulative necrosis of the tumour and surrounding vasculature that feeds the tumour, and the heated saline takes a margin around the tumour as well. Participants will undergo surgical lobectomy as their standard of care 5 - 14 days after undergoing the bronchoscopy with heated saline. Pathology on the removed lung tissue (and area treated with heated normal saline) will be performed to confirm complete tumour kill.
It is hoped that findings from this study will show that the heated saline completely kills the tumour and therefore, provides an option for a procedure to kill a cancerous tumour in patients that cannot tolerate lung surgery.
Trial website
N/A
Trial related presentations / publications
Public notes
Interested subject should also have current COVID-19, RSV, pneumococcal and influenza vaccination (or documented clinical intolerance or patient refusal) to be eligible for this study.

Contacts
Principal investigator
Name 135182 0
Dr Alan Carew
Address 135182 0
The Prince Charles Hospital 627 Rode Rd Chermside QLD 4032
Country 135182 0
Australia
Phone 135182 0
+61 7 31396904
Fax 135182 0
Email 135182 0
[email protected]
Contact person for public queries
Name 135183 0
Dr. Alan Carew
Address 135183 0
The Prince Charles Hospital 627 rode Rd Chermside QLD 4032
Country 135183 0
Australia
Phone 135183 0
+61 7 31396904
Fax 135183 0
Email 135183 0
[email protected]
Contact person for scientific queries
Name 135184 0
Ms. Julie Arneson
Address 135184 0
Morair Medtech, 401 N. 36th St., Suite 202, Seattle, WA 98103
Country 135184 0
United States of America
Phone 135184 0
+12533348543
Fax 135184 0
Email 135184 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 sets will not be analyzed in this study


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.